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1.

In Russia, we prefer to buy over-the-counter products, like cold remedies or _____,


from people in pharmacies wearing white lab coats.
→ cough syrup @

2. With your input, I'll be able to finalize the timelines for planning and
implementation and decide on ______(s) before our next meeting.
→ milestone @

3. Pharmaceutical companies must report serious ______events to the health


authorities.
→ adverse @

4. Unlike in many countries , you'll also find many cheerful, bright coloured ads in
magazines, which promote ______ and other prescription drugs in the US.
→ anti-depressant @

5. As far as Marketing is concerned, Carole Marks will be flying in from France.


She'll give us more information on the ______(s) and a target patient profile.
→ marketing claim @

6. Unlike in many countries, you'll also find many ______, bright coloured ads in
magazines, which promote anti-depressants and other prescription drugs in the US.
→ cheerful @

7. We _______ the raw materials into drugs, package them, and put in the leaflets for
the patients.
→ compound @

8. We plan to launch all of these products in Europe first and to ______ food and drug
administration (FDA) approval in the US the following year.
→ apply for @

9. Before they become fully qualified, pharmacists in the US have to take an


examination to get a _____ to practise pharmacy.
→ licence @

10. We compile the drug documentation and send it to the regulatory _______ so we
can get authorization to market the product.
→ drug authority @

11. A project manager co-ordinates and manages the ______ teams that develop and
launch a new product.
→ cross-functional @
12. _________ is an investigation to determine the advantages, practicality, and
profitability of a proposed project.
→ Feasibility study @

1
13. _________ department compiles the drug documentation and submits it to the
drug regulatory authorities so the company can get authorization to market the
product.
→ Regulatory Affairs @

14. __________ department ensures that products meet the standards which the law
requires, and contain the active ingredients advertised.
→ Quality Assurance (QA) @

15. Feasibility study is an ______ to determine the advantages, practicality, and


profitability of a proposed project
→ investigation @

16. _______ is someone whose job is to give advice on a particular subject.


→ consultant @

17. You need to be able to write scientifically and technically _____ protocols in
English.
→ accurate @

18. Since the conclusion of our successful feasibility study, we have also obtained
very _____ preclinical data.
→ encouraging @

19. __________ department plans the promotion and distribution of drugs which will
be launched, and makes decisions about the packaging or tablet colour of new
products.
→ Marketing and Sales @

20. ___________'s job is to make sure that suitable, clean containers are used to get
the product from the company to the patient.
→ Packaging technician @

21. Formulation scientists develop ______ dosage forms.


→ pharmaceutical @

22. A __________ co-ordinates and manages the cross-functional teams that develop
and launch a drug.
→ Project manager @

23. Since the ______ of our successful feasibility study, we have also obtained very
encouraging preclinical data (= end)

→ conclusion @

2
24. __________ operates complex scientific instruments and performs tests to
determine whether ingredients in liquids, powders, or tablets meet requirements.
→ Laboratory technician @

25. In Europe, the strength of medicine varies ______ depending on what health
authorities allow.
→ considerably @

26. __________ is a medication to reduce or eliminate pain.


→ Analgesic @

27. __________ means involving two or more different cultures.


→ Cross-cultural @

28. Quality is important all over the world, but in Japan we take it one step further.
We will reject a whole shipment of drugs if we find the smallest scratch or ______ in
one single package, even if it makes no difference to the product at all.
→ imperfection @

29. Project members from Marketing, Production, and Clinical Affairs are already
______
→ on board @

30. We test or organize testing on live subjects and make sure that our drugs are safe
and ______ for the patients.
→ effective @

31. I collect drug safety information about patients on our _______(s).


→ medication @

32. I received my master's ______ at New York University and licence to practise
pharmacy in the United States
→ degree @

33. __________drug is the medicine bought in a pharmacy and requiring a written


note from the doctor.
→ Prescription @

34. Ointment is a(n) _____ substance like a cream


→ oily @
35. Charley is to describe the technical equipment needed with a ________ by the end
of the month.
→ cost estimate @

36. __________ performs clinical trials. __________ must also summarize, interpret
and process clinical data.

3
→ Clinical research associate @

37. A(n) ______ is a short official note that is sent by one person to another within the
same company or organization.
→ memo @

38. __________ stands for master of science degree.


→ MSc @

39. __________ is someone you work with; a co-worker


→ Colleague @

40. Feasibility study is an investigation to _____ the advantages, practicality, and


profitability of a proposed project.
→ determine @

41. __________ is the information about a medication that is assessed before clinical
trials.
→ Preclinical data @

42. I was involved in the initial ______ phase, the planning and building of our new
pharmaceutical facility in Shanghai, and now I am the plant manager.
→ conceptual design @

43. We compile the _________ and send it to the regulatory drug authorities so we
can get authorization to market the product.
→ drug documentation @

44. __________ department tests or organizes testing on live subjects, and makes sure
that the drugs are safe and effective for the patients.
→ Clinical Affairs @

45. __________ means to take medicine without consulting a physician.


→ Self-medicate @

46. We will need to fill the position of clinical trial manager shortly. I'd appreciate it if
you could write up a job _______ with the input below and place it in the
pharmaceutical journal we normally use.
→ advertisement@

47. Formulation scientists _____ pharmaceutical dosage forms.


→ develop@

48. A __________ develops pharmaceutical dosage forms.


→ Formulation scientist@

4
49. Feasibility study is an investigation to determine the advantages, practicality, and
_____ of a proposed project.
→ profitability@

50. Some companies are successful at marketing their drugs all over the world without
making any major changes to them. Others have different formulations, advertising,
and packaging in each country, due to differences in ______(s) and laws.
→ custom@

51. _______ is an organization that provides support to the pharmaceutical,


biotechnology, and medical device industries in the form of research services
outsourced on a contract basis.
→ clinical research organization (CRO) @

52. A __________ is a company which is part of a larger and more important


company.
→ Subsidiary@

53. __________ department compounds the raw materials into drugs, packages them,
and puts in the leaflets for the patients.
→ Production@

54. A _______ is a key position in the management of clinical trials. He is responsible


for managing the clinical trial process by implementing effective strategies for his/her
organization.
→ clinical trial manager@

54. __________ department finds new substances to make new drug formulations or
changes existing dosage forms, for example, from tablets to capsules.
→ Research and Development (R&D) @

55. With your input, I'll be able to _____ the timelines for planning and
implementation and decide on milestones before our next meeting.
→ finalize@

56. __________ stands for bachelor's degree.


→ B.S. @

57. __________ are rules or laws about health.


→ Health regulations@

58. __________ stands for master's degree.


→ MS@

59. I _____ complex scientific instruments and perform tests to determine whether
ingredients in liquids, powders, or tablets meet requirements.

5
→ operate@

60. I did research on clinical ________.


→ methodology@

61. Pharmaceutical companies must report serious adverse events to the ______.
→ health authority@

62. We plan to ______ our new drug in Europe first and to apply for Food and Drug
Administration (FDA) approval in the US the following year.
→ launch@

63. A __________ is personally responsible for the quality of each product that leaves
the production line. A __________ must manage all the processes in production, QA,
and the labs to make sure SOPs are followed.
→ Qualified person@

63. ______ is a material used to wrap or protect good that are sold in stores
→ packaging@

64. Feasibility study is an investigation to determine the advantages, _______, and


profitability of a proposed project.
→ practicality@

65. I would like you to introduce yourselves and say something about your
professional background, area of _______.
→ expertise@

66. I operate complex scientific instruments and perform tests to determine whether
ingredients in liquids, powders, or tablets ______.
→ meet requirements@

67. __________ is an oily substance like a cream.


→ Ointment@

68. I am the clinical trial manager ______ this project and am supported by two
clinical research associates who will work with test centres in northern Italy and in
Slovenia
→ assigned to@

69. When people __________ with another, they work together and keep each other
informed about what is happening.
→ Liaise@

70. It's the __________ job to research, write, and edit clinical and study reports
before the pharmaceutical company submits them to regulatory authorities.

6
→ Medical writer@

71. Regulatory affairs department compiles the drug documentation and submits it to
the drug regulatory authorities so the company can get authorization to _____the
product
→ market . @

72. __________is a substance in a drug.


→ Ingredient @

73. A __________ collects drug safety information after approval and reports any
serious adverse events to the health authorities.
→ Pharmacovigilance manager . @

74. By the end of the meeting I hope we will have come up with _______ for getting
the project off the ground and a full to do list.
→ deliverables . @

75. _____ a dry substance in the form of very small grains.


→ powder . @

76. Pharmaceutical products in the__________ are future drugs, not yet on the market.
→ pipeline . @

77. CRO is searching for omeone to co-ordinate and perform _______ for stability
studies of new products.
→ analytical testing . @

78. The marketing department plans the _____ and distribution of drugs which will be
launched, and make decisions about the packaging or tablet colour of new products
→ promotion . @

79. In Russia, we prefer to buy over-the-counter products, like cold remedies or


______ syrup, from people in pharmacies wearing white lab coats
→ cough . @

80. According to European law, a qualified person is responsible for the quality of
each product that leaves the ______.
→ production line . @

81. __________ stands for bachelor of science degree.


→ BSc . @

82. ________a date or time by which you have to do or complete something.


→ deadline . @

7
83. In France, medicines should not only ______ a disease, but also look fresh and
interesting.
→ cure . @

83. _________ is a condition in which faeces are discharged from the bowels
frequently and in a liquid form.
→ Diarrhoea@

84. Medication must meet four criteria in order to abtain the status of a non-
prescription or over-the counter (OTC) product. It must have: a large margin of safety,
low incidence of side effects, low potential for ______ and abuse, and - labelling that
provides adequate directions for sale and effective use.
→ misuse@

85. When you ______ food, you use your teeth to break it up in your mouth so that it
becomes easier to swallow.
→ chew@

86. __________medicine can be purchased without a prescription but only with the
personal involvement of a pharmacist.
→ Behind-the-counter@

87. __________ is chewed prior to swallowing. It is designed for administration to


children e.g. vitamin products.
→ Chewable tablet@
88. Drug development is the process of ________ scientific discoveries made during
the research process, with the goal of producing a marketable drug.
→ carry forward@

89. An inhaler is an aerosol dispensing _____ which releases medication into the
mouth of the patient.
→ device@

90. __________ is a solid preparation that is intended to dissolve or disintegrate


slowly in the mouth (e.g.. Sore throat)
→ Lozenge@

91. __________ is the study of drugs, how they work, and what they do in the body.
__________ can be divided into two separate areas: Pharmacodynamics and
Pharmacokinetics.
→ Pharmacology@

92. __________ is the inflammation of the bronchial tubes, characterized by


coughing, difficulty in breathing.
→ Bronchitis@

8
93. __________ is the process of testing chemical compounds, with the goal of
finding a substance which has a beneficial effect on a targeted disease.
→ Research@

94. Pharmaceutical product labelling must provide ______ directions for sale and
effective use.
→ adequate@

95. Mensamint is a new dosage form of Mensadent. Known side effects often include
loss of sleep if taken in the late afternoon or evening. Occasionally, an increase in
blood pressure may _____.
→ occur@

96. __________ is the inflammation of the lungs. The lungs become filled with liquid
which makes it difficult to breathe.
→ Pneumonia@

97. One of criteria to obtain the status of OTC product in the US is that a medication
must have low _______ of side effects.
→ incidence@

98. __________is an uncoated tablet containing substances that react in the presence
of water and give off carbon dioxide.
→ Effervescent tablet@

99. A specialist or ____ in the scientific field of chemistry is called a chemist.


→ expert@

100. __________ is administered by placing it under the tongue.


→ Sublingual tablet@

101. __________ is a liquid in which another substance has been dissolved.


→ Oral solution@

102. __________ is a lung condition which causes difficulty in breathing.


→ Asthma@

103. One of criteria to obtain the status of OTC product in the US is that a medication
must have low potential for misuse and _____.
→ abuse@

104. __________ is the path by which a drug, fluid, poison, or other substance is
taken into the body.
→ Route of administration@

9
105. Mensamint is a new dosage form of Mensadent ( _________ with plysician's
prescription only)
→ Obtainable@

106. __________ is the body's exaggerated immune response to an internal or surface


agent.
→ Allergic reaction@

107. An __________ is an illness, especially one that is not very serious.


→ Ailment@

108. _______ is a container with a liquid that is administered in spray form.


→ aerosol@

109. __________ is the proportion of a drug or other substance which enters the
circulation when introduced into the body and so is able to have an active effect.
→ Bioavailability@

110. Suppository is a solid medicine which_____(s) slowly in the rectum or vagina.


→ melt@

111. A __________ illness or disability lasts for a very long time. Opposite to acute.
→ Chronic@

112. __________ is a type of capsule that is usually used to contain oils and for active
ingredients that are dissolved or suspended in oil.
→ Soft gelatin capsule@

113. Medicine needs to be easily accessible. This is, of course, a question of public
health. On the other hand, these same products can _____ if used incorrectly. This
danger must be avoided.
→ do harm@

114. __________ are fluid preparations (aqueous) for external application without
friction.
→ Lotions@

115. __________ is a unique, pharmacologically active product that has never


previously been synthesized or used to treat disease.
→ New chemical entity@

116. __________ is a drug delivery system consisting of a semi-solid, jelly-like


substance.
→ Gel@

10
117. When substances are taken with alcohol or antibiotics, their chemical form could
change and even cause ______ side effects.
→ harmful@

118. __________ is a type of capsule that is usually used to contain medicine in the
form of dry powder or very small pellets.
→ Hard gelatin capsule@

119. Toxicology is the science of poisons, including their source, chemical _______,
action, tests and their antidotes.
→ composition@

120. An __________ is someone who stays in a hospital while they receive their
treatment.
→ Inpatient@

121. Chemists and ________(s) are also interested in how the medicine is
administered, so they often ask about its formulation.
→ pharmacologist@

122. __________ is an expert in chemistry. In the UK, this word is also used for the
person who prepares and sells medicine, also known as a pharmacist in the US.
→ Chemist@

123. Solution is a liquid in which another substance has been _____(d)


→ dissolve@

124. Research is the process of testing chemical compounds, with the goal of finding a
substance which has a ______ on a targeted disease.
→ beneficial effect@

125. Some medications are available in _____ form, such drops or syrup.
→ liquid@

126. __________ means a drug preparation that gradually releases an active substance
over a period of time.
→ Time-release delivery@

127. __________ is an oily liquid to rub on painful body parts to reduce pain.
→ Liniment@

128. __________ is a medication on material or cloth placed on the skin.


→ Patch@

129. Patches are easy to _______, not too expensive, and can be placed right at the
point of pain.

11
→ apply@

129. __________ is a substance dispensed as a fine spray from a container into the
nostril.
→ Nasal spray@

130. __________ is the condition of feeling sick and the feeling that you are going to
vomit.
→ Nausea@

131. __________ is the study of poisons.


→ Toxicology@

132. In the fields of medicine, biotechnology and pharmacology, drug ______ is the
process by which new candidate medications are discovered.
→ discovery@

133. __________ refers to a group of diseases that affect how your body uses blood
sugar (glucose).
→ Diabetes@

134. If you have __________ , you have pains in your stomach and chest that are
caused by difficulties in digesting food.
→ Indigestion@

135. If a wound or a part of your body becomes __________ , it becomes infected.


→ Septic@

136. __________ is a sweet, liquid medicine taken with a spoon or cup.


→ Syrup@

137. __________ is a small, round piece of medicine to be swallowed without


chewing.
→ Pill@

138. __________is the amount of substance given at one time.


→ Dose@

139. __________ is Phase-1 study in which a test product is administered to human


beings.
→ First in-man study@

140. In Canada, Behind-the-counter medicines are those that a patient can obtain
without a prescription, but only with the personal ______ of a pharmacist.
→ involvement@

12
150. When someone has _______, their heart beats very fast in an irregular way.
(conditions of heart racing.)
→ palpitations@

151. We will have to test the bioavailability to be able to calculate dosages for non-
intravenous routes of _____ for this NCE.
→ drug administration@

152. __________ are a kind of medicine that you put in your eyes one drop at a time.
→ Eye drops@

153. __________ is the final form of the medicine, e.g. Tablet, powder, gel, spray, etc.
→ Dosage form@

154. ________is a medical condition in which there are too few red cells in your
blood, causing you to feel tired and look pale.
→ anaemia@

155. At present, the Food and Drug Administration is reviewing its current ______ on
the number of categories of medicines.
→ policy@

156. __________ is the amount and frequency of a medicinal drug that may be taken
safely.
→ Dosage@

157. An Inhaler is a small device with medicine to _____ through the mouth.
→ breathe in@

158. __________ are semi-solid, smooth greasy preparations for application to the
skin for healing.
→ Ointments@

159. Medication must meet four criteria in order to obtain the status of a non-
prescription or OTC. It must have: a large ______, low incidence of side effects, low
potential for misue and abuse, and labelling that provides adequate directions for sale
and effective use.
→ margin of safety@

160. __________ is a hard, compressed medication in round, oval or square shape


→ Tablet@

161. Someone who suffers from __________ finds it difficult to sleep.


→ Insomnia@

162 Toxicology is the study of _____.

13
→ poison@

163. __________ is the study of the bodily absorption, distribution, metabolism, and
excretion of drugs (what the body does to the drug)
→ Pharmacokinetics@

164. Which of the following dosage form(s) do the patients _____ (= prefer)?
→ favour@

165. __________ drug is a product which can be sold without the patient seeing a
doctor.
→ Over-the-counter@

166. __________ is a mixture of ingredients prepared in a certain way and used for a
specific purpose.
→ Formulation@

167. OTC Pharmaceutical products must have labelling that provides adequate _____
for sale and effective use.
→ directions@

168. __________ is the degree to which a substance (a toxin or poison) can harm
humans or animals.
→ Toxicity@

169. Mensamint is a new dosage form of Mensadent. Known side effects often include
loss of sleep if taken in the late afternoon or evening. ______ (now and then ), an
increase in blood pressure may occur.
→ occasionally@

170. The science of poisons, including their source, chemical composition, action,
tests , and even their _____(s) , is what we call Toxicology
→ antidote@

171. __________dosage forms are applied to the skin surface.


→ Topical@

172. __________ is a solid medicine which melts slowly in the rectum or vagina.
→ Suppository@

173. If you have a __________ when you are ill, your body temperature is higher than
usual.
→ Fever@

174. __________ is the process of carrying forward scientific discoveries made during
the research process, with the goal of producing a marketable drug

14
→ Development@

175. Scientists have made a major ______ in the treatment of cancer.


→ breakthrough@

176. __________ is an expert in the science of poisons.


→ Toxicologist@

177. Suppository is a solid medicine which melts slowly in the _______ or vagina.
→ rectum@

178. __________ is the study of physiological effects of drugs and the mechanisms of
their actions (what the drug does to the body)
→ Pharmacodynamics@

179. __________ is a scientific study designed to systematically test a medical


intervention in humans.
→ Clinical trial@

180. __________ are liquid preparations for oral use that are intended to be
administered in small amount with the aid of a suitable measuring device.
→ Oral drops@

181. __________ dosage forms are breathed in through mouth or nose and are often
used to treat respiratory diseases.
→ Inhaled@

182. Even a product that has been marketed for years might have to be taken off the
market in a __________ if serious adverse reactions occur.
→ Product recall@

183. We should tell the lab staff to _____ that all the labs are spotlessly clean and that
all lab devices and equipment are where they should be - at every single workstation.
→ double-check@

184. __________ stands for Good Research Practice


→ GRP@

185. Endpoint testing is carried out at the end of every manufacturing process. This is
to ensure that all procedures have been performed in _________with industry and
company standards.
→ compliance@

186. ______ and validation are required to prove that the manufacturing and testing
equipment is functional
→ inspection@

15
187. __________ is a chemical that damages cellular DNA, resulting in mutations or
cancer.
→ Genotoxic substance@

188. A/An __________ inspects and verifies the safety procedures in the lab.
→ auditor@

189. __________ involves all manufacturing processes in GMP which make sure the
goods produced are kept at high standards.
→ Quality assurance@

190. __________ prevents occurrence of errors


→ Preventive action@

191. Please ______ receipt of this memo and send us a copy of all your
correspondence with regard to this scheduled audit.
→ confirm@

192. Validation of cleaning processes is essential in this industry, because chemical or


_______ contamination of drug products can potentially lead to severe public health
risks.
→ bacterial@

193. Proper documentation not only _____(s) traceability, but also allows a complete
product recall from the market.
→ to enable@

194. Inspection and validation are required to prove that the manufacturing and testing
equipment is ______.
→ functional@

195. __________ involves interim and product sampling procedures, which are
carried out to check product quality.
→ Quality control@

196. __________ stands for Corrective Action/Preventive Action. It is a part of the


overall Quality Management System (QMS) required for GMP
→ CAPA@

197. A/an __________ is a safety device consists of a sheet of a fire retardant material
which is placed over a fire in order to extinguish it.
→ Fire blanket@

198. A(n)_____ audit of safety procedures in all laboratories is carried out yearly.
→ annual@

16
199. ___________ is a/an apparatus to wash the eyes after exposure to chemical
contamination.
→ Eye bath@

200. The company claims that a cleaning error was the reason for the entire incident.
This clearly underlines the ______ of underestimating the importance of the cleaning
process in pharmaceutical manufacturing.
→ danger@

201. I suggest you _____ of toxic waste in the bins provided for this purpose.
→ dispose@

202. The quality assurance process in ______ (GMP) includes product quality control,
sampling, and testing.
→ Good Manufacturing Practice@

203. Although there were no serious instances of non-compliance, a number of


incidents of undesirable conditions and practices were observed. These need to be
corrected before the _______ review in 30 days
→ follow-up@

204. Documentation is important and necessary at every step of the processes,


activities, and ______(s) involved in drug manufacturing.
→ operation@

205. __________ drugs are no longer pure and acceptable for sale or public use and,
therefore, must be returned to the manufacturer, or destroyed.
→ Contaminated@

206. A/an __________ is a device that you wear over your face in order to protect
yourself from poisonous gases.
→ Gas mask@

207. _________ stands for Good Safety Practice


→ GSP@

208. Proper protective clothing and safety ______ must be worn at all times
→ equipment@

209. Endpoint testing is carried out at the end of every manufacturing process. This is
to ensure that all _______(s) have been performed in compliance with industry and
company standards.
→ Procedure@

300. Auditors generally watch or _______safety procedures in the lab.

17
→ observe@

301. According to reports, it seems that an unanticipated reaction between the drug's
active ingredient and the chemicals used as part of the cleaning processes at the site
was the ______ of the contamination.
→ cause@

302. Endpoint testing is carried out at the end of every manufacturing process to
_____ that all procedures have been performed in compliance with industry and
company standards.
→ ensure@

303. Standard operating procedures (SOPs) are written and used by companies to
make it easier for them to follow GxP These are a set of written instructions to
maintain ______ and results
→ performance@

304. Proper ______ and safety equipment must be worn at all times.
→ protective clothing@

305. ______ the field of manufacturing, good practice must be adhered to in all
processes in a pharmaceutical company. No process can be considered isolated from
the others.
→ beyond@

306. Documentation is important and necessary at every step of the processes,


activities, and operations ______ drug manufacturing.
→ involved in@

307. __________ are shoe covers used to reduce foot borne contamination and help
maintain a sterile environment.
→ Overshoes@

308. All work with virus- infected animals must be performed in the _______.
→ bio-safety cabinet@

309. You need to ______ all equipment following any experiments with laboratory
animals.
→ disinfect@

310. The quality assurance ______ in good manufacturing practice (GMP) includes
product quality control, sampling, and testing.
→ process@

311. Preventive action prevents ______ of errors.


→ occurrence@

18
312. ______ is important and necessary at every step of the processes, activities, and
operations involved in drug manufacturing.
→ documentation@

313. The goal of an internal audit is to identify any areas requiring corrective or
preventive actions. It is done to ______ compliance with industry standards,
especially for safety procedures.
→ assure@

314. Contaminated products are no longer _______ and acceptable for sale or public
use and, therefore, must be returned to the manufacturer, or destroyed.
→ pure@

315. All operational methods and procedures must also be inspected for ______.
→ accuracy@

316. A well-known European pharmaceutical company was forced to recall one of its
drugs ________ claims of product contamination.
→ due to@

317. Beyond the filed of manufacturing, good practice must be ______(ed) to in all
processes in a pharmaceutical company
→ adhere@

318. To ensure that laboratory workers are asked certain questions about safety
procedures, auditors use a __________.
→ Checklist@

319. Aspirin mainly used for ______ and fever.


→ pain relief@

320. An internal __________ involves inspection and validation of operational


methods, procedures, equipment to ensure functionality, accuracy and validity.
→ Audit@

321. __________ stands for Good Manufacturing Practice.


→ GMP@

322. Disinfectant must be used on all equipment following an _______ with


laboratory animals.
→ experiment@

323. A well-known European pharmaceutical company was ____(ed) to recall one of


its drugs due to claims of product contamination.
→ force@

19
324. Protective glasses/_____ must be worn at all times in the laboratory.
→ goggles@

325. Corrective Action/Preventive Action (CAPA) focuses on the systematic


investigation of non-conformance events (errors or _______(s)), to prevent their
occurrence (for preventive action) or recurrence (for corrective action).
→ deviation@

326. A __________ looks at all aspects of a pharmaceutical company together to


make sure that the entire process meets high industry standards.
→ Holistic approach

327. Manufacturing processes and procedures must go through periodic __________


to guarantee that they are still of an acceptable standard.
→ Validation@

328. Scientists often read journals and go to international conferences, because they
need to stay _________ in their scientific fields.
→ up-to-date@

329. Toxic or ______ materials must be disposed of properly.


→ hazardous@

330. The reason for ________, or product sampling, is to check the quality of
pharmaceutical products
→ interim testing@

331. ______ documentation not only enables traceability, but also allows a complete
product recall from the market, if necessary.
→ proper@

332. Small _______ spills must be covered with a paper towel and treated with bleach
.
→ biological agent@

333. A few years ago, a well-known European pharmaceutical company was forced to
recall one of its drugs due to claims of product contamination. The drug manufacturer
was unable to say just how many patients were taking this drug at the time. However,
it estimated the _____figure at over 40,000 people.
→ global@

334. _______ of this meeting was very short.


→ advance notice@

20
335. Any observation or _______ noted by the auditors is categorized as either major,
minor, or critical.
→ Finding@

336. At the end of every stage of a product's manufacturing process, __________ is


done to maintain quality standards.
→ Endpoint testing@

337. An _____ audit involes inspection and validation of operational methods,


procedures, equipment to ensure functionality, accruacy and validity
→ internal@

338. Lab animals must be transported in _____ cages.


→ covered@

339. A few years ago, a well-known European pharmaceutical company was forced to
recall one of its drugs due to claims of product _____.
→ contamination@

340. __________ prevents recurrence of errors


→ Corrective action@

341. A few years ago, a well-known European pharmaceutical company was forced to
recall one of its drugs due to _____s of product contamination.
→ claim@

342. Small biological agent spills must be covered with a paper towel and treated with
________ .
→ bleach@

343. The reason for interim testing, or __________, is to check the quality of
pharmaceutical products.
→ Product sampling@

344. CAPA focuses on the systematic investigation of non-conformance events (errors


or deviations), to prevent their occurrence (for preventive action) or_______ (for
corrective action).
→ recurrence@

345. The quality assurance process in good ______ practice (GMP) includes product
quality control, sampling, and testing.
→ manufacturing@

346. __________ (QMS) is a formalized system that documents processes,


procedures, and responsibilities for achieving quality policies and objectives.
→ Quality Management System@

21
347. Please confirm _____ of this memo and send us a copy of all your
correspondence with regard to this scheduled audit.
→ receipt@

348. All laboratory work must be documented in ________ GLP.


→ accordance with@

349. It is absolutely essential to move lab mice outdoors in closed ____(s) .


→ cage@

350. The documentation required for all research processes and development steps
ensures the __________ of a drug.
→ Traceability@

351. __________ stands for Good Documentation Practice


→ GDP@

352. Corrective Action/Preventive Action (CAPA) is a part of the overall Quality


Management System (QMS) required for GMP. It ____(es) on the systematic
investigation of non-conformance events (errors or deviations), to prevent their
occurrence (for preventive action) or recurrence (for corrective action).
→ focus@

353. A product recall took place following reports from patients that their medication
had a strange odour. Several patients from a number of different countries made the
_______ within a short period of time.
→ complaint@

354. If any __________ is observed during the audit, the department will be informed
so they can take corrective action.
→ non-compliance@

355. Special containers are provided for the _______ of toxic waste materials.
→ disposal@

356. Corrective _____ / Preventive ______ ( CAPA ) is a part of the overall Quality
Management System ( QMS) required for GMP .
→ action@

357. Special ______(s) are provided for the disposal of toxic waste materials.
→ container@

358. ______ must be used on all equipment following any experiments with
laboratory animals.
→ disinfectant@

22
359. _________ are a set of written instructions to maintain performance and results.
They are the basis of good QA and QC system.
→ Standard operating procedures (SOPs) @

360. Standard operating procedures (SOPs) are written and used by companies to
make it easier for them to follow GxP. These are a set of written instructions to
_____performance and results
→ maintain@

361. __________ make sure that the health and well-being of laboratory workers are
guaranteed.
→ Safety procedures@

362. Contaminated products are no longer pure and acceptable for sale or public use
and, therefore, must be returned to the ______ or destroyed.
→ manufacturer@

363. __________ stands for Good Auditing Practice.


→ GAP@

364. __________ stands for Good Laboratory Practice.


→ GLP@

365. Endpoint testing is carried out at the end of every manufacturing process. This is
to ensure that all procedures have been performed ______ industry and company
standards.
→ in compliance with@

367. _______ disposal of toxic waste material was recorded. (= incorrect/ wrong)
→ improper@

368. This memo is to_____ you that your department has been scheduled for a
periodic audit of the laboratory safety systems and procedures.
→ advise@

369. An __________ is a distinctive unpleasant smell.


→ Odour@

370. Any observation or finding noted by the auditors is _______(d) as either major,
minor, or critical.
→ categorize@

371. All _______ procedures and methods must also be inspected for accuracy.
→ operational@

23
372. Even a product that has been marketed for years might have to be taken off the
market if serious _________(s) occur.
→ adverse drug reaction@

373. To ______ something means to make it easier to understand, usually by


explaining it in more detail.
→ clarify@

374. __________ stands for Good Clinical Practice.


→ GCP@

375. Drops of liquid administered to the eye.


→ gtt@

376. (Heart Rate) is the frequency with which a person's heart beats in a given amount
of time. It is usually expressed in beats per minute.
→ HR@

377. (intramuscular injection) A medicine that is injected into a muscle with a syringe.
→ IM@

378. A measure of volume equal to the amount a standard teaspoon can hold, or
almost five milliliters.
→ teaspoonful (tsp) @

379. a unit of volume equal to a cube whose sides are equal to one centimeter.
→ cubic centimeter (cc) @

380. A unit of mass equal to one thousandth of a gram.


→ milligram (mg) @

381. (Diagnosis) is the positive identification of a patient's disease or ailment.


→ Dx@

382. If medicine is given ______ (by mouth), it is taken orally, or through the mouth.
→ P.0. @

383. a unit of mass equal to one millionth of a gram.


→ microgram (mcg) @

384. An X-ray is a visual image of all or part of the body acquired with special
equipment using electromagnetic radiation to see bones and other internal aspects of
the body.
→ XR@

24
385. A unit of liquid volume equal to one thousandth of a liter and equal to one cubic
centimeter.
→ milliliter (ml) @

386. The path by which a medicine is taken into the body.


→ route of administration@

387. (sublingual) Medicine that is given beneath the tongue.


→ SL@

388. a unit of mass which is equal to one-thousandth of a kilogram,


→ gram (g) @

389. A unit of weight equal to 1/16th of a pound.


→ ounce (oz) @

390. If a medicine is given ______(per rectum), it is taken through the rectum.


→ P.R. @

391. Medicine is applied to a certain part of the surface of the body.


→ topical@

392. (treatment/ prescription) is the specific drug or course of action prescribed to


treat a patient's medical condition.
→ Rx@

393. (hypertension) is having blood pressure that is higher than normal.


→ HTN@

394. the correct amount and frequency of medicine to give to a person.


→ dosage@

395. If a patient ______ (complains of) something, he or she describes symptoms that
are painful or uncomfortable.
→ c/o@

396. 1/1000th the weight of the minor component of a chemical solution dissolved in
the major component.
→ milliequivalent (mEq) @

397. (Short of Breath) is a condition in which a patient finds it more difficult to


breathe than usual.
→ SOB@

398. (subcutaneous) A medicine that is injected into the fatty layer under the skin with
a syringe.

25
→ SQ@

399. A measure of volume equal to the amount a standard tablespoon can hold or
about three teaspoons.
→ tablespoonful (Tbsp) @

400. To give medicine to a patient.


→ administer@

401. (temperature) is a quantitative measurement of heat within the body. It is can be


used, in part, to gauge whether the body is operating normally.
→ T@

402. (Blood Pressure) is the force exerted by circulating blood on the walls of blood
vessels. Lt is a vital sign that medical professionals use to determine whether body
systems are operating as they should.
→ BP@

403. An intravenous injection is a method of administering medicine into a vein using


a syringe, often over a long period of time.
→ I.V. @

404. If something is found ______ (on examination), it was discovered during an


exam.
→ o/e@

405. If a function is ______ (Within Normal Limits), it is operating in a normal range.


→ WNL@

406. a unit of liquid volume equal to the amount of liquid which comes from a
dropper, or about 1/12th of a milliliter.
→ drop (gtt) @

407. To ______ is to force air loudly through the throat because of an illness or throat
irritation.
→ cough@

408. If something is ______, it has liquid flowing or leaking out of it.


→ runny@

409. To ______ is to have pain that comes and goes very quickly.
→ throb@

410. ______ is a collection of information.


→ data@

26
411. Medication that is given immediately.
→ stat@

412. Medication that is given as needed.


→ PRN@

413. A(n) ______ is a pain felt in the muscles.


→ muscle ache@

414. To ______ is to breathe with difficulty in a noisy manner.


→ wheeze@

415. Medication that is given every hour.


→ qh@

416. A(n) ______ is an illness that can cause coughing, a runny nose, and a sore
throat.
→ cold@

417. Medication that is given after meals.


→ pc@

418. A(n) ______ is a medical treatment performed by a doctor or surgeon.


→ procedure@

419. If something is ______, it is happening at the present time.


→ current@

420. A(n) ______ is a record of the medical conditions of a patient's family that might
affect the patient's health.
→ family medical history@

421. ______ is a viral illness that can cause fevers, aches, and wheezing,
→ flu@

422. If someone has a ______ something, he or she has experienced it regularly or


repeatedly.
→ history of@

423. Medication that is given at bedtime.


→ qhs@

424. A(n) ______ is pain or illness reported by a patient.


→ complaint@

425. Medication that is given three times per day.

27
→ TID@

426. Medication that is given four times per day.


→ QID@

427. Medication that is given every other day.


→ QOD@

428. A(n) ______ is a medical condition that causes a reaction or illness when
someone comes in contact with a particular substance.
→ allergy@

429. A(n) ______ is a pain felt in the head.


→ headache@

430. A medication that is taken before meals.


→ ac@

431. A(n) ______ is a patient's record of lifestyle and personal details, such as
occupation and marital status.
→ social history@

432. A(n) ______ is an illness that causes body temperature to rise,


→ fever@

433. A(n) ______ (PMH) is a patient's record of previous illnesses, procedures, and
other medical details.
→ past medical history@

434. A(n) ______ is the start or first instance of something.


→ onset@

435. If a medication that is given twice per day.


→ BID@

436. A(n) ______ is a feeling or physical change that indicates illness.


→ symptom@

437. A(n) ______ is an organized examination of a patient's physiological state as


compared to what is understood to be normal.
→ inspection@

438. A(n) ______ is a report that discusses what was found after cells and tissue were
examined.
→ pathology report@

28
439. ______ is the use of x-rays to view images of the internal human body.
→ radiography@

440. To _____ an endoscopic tube is to insert it into the body in order to take internal
pictures,
→ feed@

441. ______ is a waste product found in blood that the kidney usually removes.
→ creatinine@

442. ______ are statistical measures of essential body functions such as temperature,
pulse rate, blood pressure, and respiration.
→ vital signs@

443. ______ is the conveyance of information about a person's physiological or


emotional state by the way he or she moves.
→ body language@

444. A(n) ______ is a medical imaging technique that uses the reflection of sound
waves to produce an image of the body.
→ ultrasound@

445. A(n) ______ is a medical procedure in which a piece of tissue is removed and
examined to help determine an illness.
→ biopsy@

446. ______ (CKD) is a medical condition in which a person loses kidney function
over time.
→ chronic kidney disease@

447. ______ is a semi-solid substance placed between the patient's skin and an
ultrasound probe.
→ gel@

448. ______ is the examination of something by touch.


→ palpation@

449. ______ is the process of creating pictures of the human body for the purpose of
diagnosing and treating medical problems.
→ medical imaging@

450. To ______ something such as mood is to bring about a change in it.


→ affect@

451. ______ is the act of tapping on an area of the body such as the chest or abdomen
to determine the condition of the underlying bone or tissues.

29
→ percussion@

452. A(n) ______ (MRI) is a medical imaging technique that uses magnetic forces on
atoms to produce an image of the body.
→ magnetic resonance imaging@

453. ______ is a type of protein found in the body.


→ albumin@

454. A ______ (BUN) test is a test to determine the amount of urea nitrogen in the
blood.
→ blood urea nitrogen test@

455. A(n) ______ is a test that examines a urine sample.


→ urinalysis@

456. A(n) ______ is a measure of heartbeats in a given period of time. One way to
take this measurement is to place the fingers over a major artery in the neck, wrist, or
other location and press them against a bone to feel the palpations of the heart as
blood moves through the artery.
→ pulse@

457. A ______ (GFR) test is a test to determine how much kidney function a person
has.
→ glomerular filtration rate test@

458. ______ is the examination of something by listening with or without an


instrument such as a stethoscope.
→ auscultation@

459. A(n) ______ is a thin, tubular instrument used to examine the inside of an organ
or body cavity.
→ endoscope@

460. ______ is a measure of the pressure with which blood moves through the body.
→ blood pressure@

461. A(n) ______ is a form of medical imaging that uses many two-dimensional X-
rays to create a three-dimensional image of an object.
→ CT scan@

462. If something is ______, it is related to the kidneys.


→ renal@

463. A(n) ______ is a form of radiation that can be used to take pictures of the internal
human body

30
→ x-ray@

464. To ______ something is to determine the qualities of its condition or state.


→ evaluate@

465. A(n) ______ (ECG)is a measurement of the electrical activity of the heart over a
period of time.
→ electrocardiogram@

466. A(n) ______ is something that someone notices, or the act of noticing something.
→ observation@

467. Creatinine _____ are higher than normal

→ levels@

468. Good morning, and welcome everyone. Great that everyone on the project team
could make it to our _____ meeting

→ kick – off@

469. _____ are statistical measures of essential body functions such as temperature,
pulse rate, blood pressure,, and respiration

→ vital signs@

470. From the notes, it seems the _____ of symptoms started after moving house

→ onset@

471. Clinical Affairs department _____ of organizes clinical trials on live subjects,
and makes sure that the drugs are safe and effective for the patients

→ conducts@

472. The last temperature reading indicated that the patient had (a)_____

→ fever@

473. At the end of every stage of a product’s manufacturing process, _____ is done to
maintain quality standards

31
→ Endpoint testing@

474. Every morning, you should put 2 _____ of natural sea water in each nostril to
clear up breathing

→ drop@

475. Which aspect of drug manufacturing enables traceability? Choose the


INCORECT answer:

→ holistic approach@

476. We plan to launch all of these products in Europe first and to _____ food and
drug administration (FDA) approval in the US the following year

→ apply for@

477. During mosquito season, applying ____ ointment helps to relieve bites

→ topical@

478. A patch is _____

→ a medication on material or cloth placed on the skin@

479. The feasibility study has just been successfully____

→ completed@

480. A tablet is a type of _____ dosage forms

→ oral@

481. Doctors need a full ____ of the patient’s condition.


→ history@

482. A ____ is a measure of volume equal to the amount a standard teaspoon can hold,
or almost five milliliters.
→ tsp@

32
483. According to reports, it seems that an unanticipated ___ between the drug's active
ingredient and the chemicals used as part of the cleaning processes at the site was the
cause of the contamination.
→ reaction@

484. Feasibility study is an investigation to


→determine the advantages, practicality, and profitability of a proposed project.@

485. Please put 2 ___ (s) of cleaning solution in each ear. Use a dropper.
→ drop@

486. An ___ injection is an injection of a medication directly into the vein.


→ Intravenous@

487. Choose the CORRECT statement about Quality assurance and auditing
→ All operational methods and procedures must be inspected and validated to isolate
products of high safety.@

488. Research is the process of testing chemical compounds, with the goal of finding a
substance which has a ____ on a targeted disease.
→ beneficial effect@

489. A holistic approach looks at ___


→ aspects of a pharmaceutical company together to make sure that the entire process
meets high industry standards. @

490. We were taught ____ techniques for the organs beneath the abdomen.
→ percussion@

491. A Project manager ____ and manages the cross-functional teams that develop
and launch a drug
→ coordinates@

492. To ____ something is to determine the qualities of its condition or state.


→ evaluate@

493. If a medication is given ____, it is given immediately.


→ stat@

494. Choose the word or phrase that matches the following definition: "a form of
medical imaging that uses many two-dimensional X-rays to create a three-dimensional
image of an object"
→ CT scan@

33
500. Pneumonia is______
→ the inflammation of the lungs@

501. Corrective action ____


→ prevents recurrence of errors@

502. The antibiotics are ____, so that’s 3 times a day


→ TID@

503. You’ll have to eat something first Mr. Jackson as your meds are to be taken
____.
→ pc@

504. Ointment is a(n) ___ substance like a cream


→ oily@

505. A(n) ____ is a medical condition that causes a reaction or illness when someone
comes in contact with a particular substance
→ allergy@

506. Common ____ of CAREFREEDO are: nausea, vomiting, abdominal pain


→ side effects@

507. Production department is responsible for:_______


→ compounding the raw materials into drugs, packages them, and puts in the leaflets
for the patients. @

508. Since the conclusion of our successful feasibility study, we have also obtained
very ___ preclinical data.
→ encouraging@

509. Toxicity is _____


→ the study of poisons. @

510. From the ____ we can see that there are no broken bones or fractures
→ XR@

511. Medication must meet four criteria in order to abtain the status of a non-
prescription or over-the counter (OTC) product. Choose the CORRECT statement:
→ It must have labelling that provides inadequate directions for sale and effective
use@

34
512. An internal ________ involves inspection and validation of operational methods,
procedures, equipment to ensure functionality, accuracy and validity
c. audit@

513. I have a fear of swallowing pills and for that reason my doctor always prescribes
pills that can be absorbed ____
→ sublingually@

514. A Pharmacovigilance manager collects drug safety information _______ and


reports any serious adverse events to the health authorities.
→ after approval@

515. Standard operating procedures (SOPs) are ________on a regular basis, often
after an audit has been carried out.
→ updated@

516.Research and Development (R&D) department finds new _______ to make new
drug ______ or changes existing dosage forms, for example, from tablets to capsules.
→ substances/ formulations

517. Choose the CORRECT statement:


→A Clinical research associate performs clinic trials. Clinical research associate must
also summarize, interpret and process clinical data.. @

518. The______ options include diet and lifestyle changes.


→Rx@

519. You are writing the SOP guideline to tell your employee to tell your employee “
Wipe up all chemical spills in the laboratory immediately”.The CORRECT guideline
is:

→ All chemical spills in the laboratory must be wiped up immediately@

520. Behind-the-counter medicine_______

→ can not be purchaced without a prescription but only with the personal involvement
of a pharmacist@

521 . The internal audit of the laboratory safery system is done to assure_____ with
industry standards, especially for safety procedures

→ compliance@

35
522. Graham is having difficulty breathing and is________a lot.

→wheezing.@

523. My son takes 1________ of Omega-3 fish oil every day before his meal.

→ tbsp.@

524. I will give you a _______ ointment to put on the scar.

→topical@

525. _______your input_______.we need the financial data from your department as
soon as possible.

→as far as…..is concerned@

526. Doctors must collect accurate_________ in order to have important details about
their patients.

→data@

527. In the Pharmaceutical industry,GAP stands for________


→ good AUDITING practice.@

528 . A Pharmacovigilance manager collects drug safety information_______ and


reports any serious adverse events to the health authorities.
→ before approval@

529. ________ is the process oftesting chemical compound, with the goal of finding a
substance which has a beneficial effect on a targeted disease.
→ Development@

530. An ________ injection is an injection of a medication directly into the vein

→ Intravenous@

531. One thousand ________ (s) make up one kilogram

36
→ G@

532. Feasibility study is a(n) ________ to determine the advantages, practicality, and
profitability of a proposed project

→ Investigation@

533. Doctor Greene, the patient is waiting for his ________

→ Rx@

534. Bioavailability is the proportion os a drug or other substance which ________

→ Enters the cieculation when introduced into the body and so is able to have an
active effect@

535. A(n) ________ is a test that examines a urine sample

→Urinalysis@

536. To ________ is to breath with difficulty in a noisy manner

→Wheeze@

537. Choose the word that match the following definition: “To is to breath with
difficulty in a noisy manner”

→SOP@

538. The optiones include diet and lifestyle changes.

→WNL@

37
539. A/an ________ a solid perparation that is intended to dissolve or disintegrate
slowly in the mouth

→Lozenge@

540. Which aspect of drug manufacturing enables traceability?

A. Quality assurance
B. Quality control
C. Quanlity assurance
D. Holistic approach

541. Please go to the radiology department immediately for a(n) ________

A. Injection
B. Pathology report
C. Physical examination
D. X-ray

542. The asthmatic patient complained of ____

→SOB@

543. Production department _____ the raw materials into drugs, packages them, and
puts in the leaflets for the patients.
→compounds@

544. A(n) ____ uses magnetic properties of atoms to create very detailed pictures.

→MRI@

545. For this patient, the correct ____ is 200 milligrams per day.

→ route of administration@

546. We will remove some tissue from your liver during the ____.

38
a. There are three catagories of drugs in Canada
b. There are four catagories of drugs in the U.S.
c. Canada has two official categories: prescription drugs and OTC drugs
d. The US has two official categories: prescription drugs and OTC drugs

547. As soon as you see the victim, check first all the ____ .

a. percussion@

548. Mr. Hallam said that he has been taking over-the-counter medicine for his ____

c. cold@

549. Mr. Hans must take his medication BID, which means ____ times a day.

→ two@

550. Regulatory Affairs department compiles the drug documentation and submits it
to the drug regulatory authorities so the company can get _______

→authorization to market the product. @

551. Pharmaceutical products in the pipeline are ____


→future drugs, not yet on the market. @

552. __________capsule is a type of capsule that is usually used to contain oils and
for active ingredients that are dissolved or suspended in oil.

a. Soft gelatin
b. Solid
c. Hard gelatin
d. Suppository

553. A Qualified person is personally responsible for the ____ of each product that
leaves the production line. A Qualified person must manage all the processes in
production, QA, and the labs to make sure Standard Operating Procedures are
followed.

a. qualify
b. quantity

39
c. quality
d. quantify

554. The internal audit of the laboratory safety system is done to assure _______with
industry standards, especially for safety procedures.
→compliance@

555. Before doing any ____ we must first know about any allergies or previous
conditions.

→procedure@

556. Bronchitis is the __ of the bronchial tubes, characterized by coughing, difficulty


in breathing.
→inflammation@

557. After taking the patient’s temperature, measure their ____ .


→pulse@

558. From the ____ we can see that there are no broken bones or fractures.

→XR@

559. An internal audit involves inspection and _____ of operational methods,


procedures, equipment to ensure functionality, accuracy and validity.

→validation@

560. The blood sample analysis shows blood sugar levels ____.

→WNL@

561. A ____ is a unit of mass which is equal to one-thousandth of a kilogram,

→g@

40
Quizizz
1. __BP__ is the force exerted by circulating blood on the walls of blood
vessels. Lt is a vital sign that medical professionals use to determine
whether body systems are operating as they should.

→ BP (Blood Pressure)

2. If a patient ___C/O___ something, he or she describes symptoms that are


painful or uncomfortable.

→ C/O (complains of )

3. ___Dx___ is the positive identification of a patient’s disease or ailment.

→ Dx

4. ___HR___ is the frequency with which a person's heart beats in a given


amount of time. It is usually expressed in beats per minute.

→ HR (Heart Rate)

5. ___HTN___ is having blood pressure that is higher than normal.

→ HTN (Hypertension)

6. If something is found ___O/E___, it was discovered during an exam.

→ O/E (on examination)

7. ____Rx__ is the specific drug or course of action prescribed to treat a


patient’s medical condition.

→ Rx

41
8. ___SOB___ is a condition in which a patient finds it more difficult to
breath than usual.

→ SOB (Short of Breath)

9. ___T___ is a quantitative measurement of heat within the body. It is can


be used, in part, to gauge whether the body is operating normally.

→T

10. If a function is ___WNL___, it is operating in a normal range.

→ WNL ( Within Normal Limits )

11. ______ is a visual image of all or part of the body acquired with special
equipment using electromagnetic radiation to see bones and other internal
aspects of the body.

→ XR

12. Choose the word that matches the following definition "to describe
uncomfortable symptoms"

→ C/O (complains of )

13. Choose the word that matches the following definition "the amount of
internal body heat measured” → T (Temperature)

14. Choose the word that matches the following definition "the identification
of an illness or disease"

→ Dx

15. Choose the word that matches the following definition "the amount of
force applied on blood vessel walls by circulating blood"

→ BP (Blood Pressure)

16. Choose the word that matches the following definition "the number of
heartbeats in a given amount of time"

→ HR

17. Choose the word that matches the following definition "to be at an average
level"

42
→ WNL

18. Choose the word that matches the following definition "discovered while
investigating a patient’s health"

→ O/E

19. The ___XR__ clearly showed that bone was broken.

→ XR

20. The asthmatic patient complained of __SOB____

→ SOB

21. ___Rx___ for the infection included antibiotics.

→ Rx

22. The patient with high blood pressure was diagnosed with ___HTN___.

→ HTN

23. A ___CC___ is a unit of volume equal to a cube whose sides are equal to
one centimeter.

→ CC (cubic centimeter)

24. A __gtt____ is a unit of liquid volume equal to the amount of liquid which
comes from a dropper, or about 1/12th of a milliliter.

→ gtt

25. A ___g___ is a unit of mass which is equal to one-thousandth of a


kilogram,

→g

26. ___gtt___(s) are drops of liquid administered to the eye.

→ gtt

27. A ___mcg___is a unit of mass equal to one millionth of a gram.

→ mcg

43
28. A ___mEq___ is 1/1000th the weight of the minor component of a
chemical solution dissolved in the major component.

→ mEq

29. A__mg____ is a unit of mass equal to one thousandth of a gram.

→ mg

30. A ___ml___ is a unit of liquid volume equal to one thousandth of a liter


and equal to one cubic centimeter.

→ ml

31. A ___tbsp___ is a measure of volume equal to the amount a standard


tablespoon can hold or about three teaspoons.

→ tbsp

32. A ___tsp___ is a measure of volume equal to the amount a standard


teaspoon can hold, or almost five milliliters.

→ tsp

33. Which of the following is equal to one ml?

→ 1 cubic centimeter

34. Choose the word that matches the following definition "a unit of mass
equal to one millionth of a gram"

→ mcg

35. Choose the word that matches the following definition "a unit of mass
equal to one thousandth of a gram"

→ mg

36. Choose the word that matches the following definition "1/1000th the
weight of the minor component of a chemical solution dissolved in the
major component"

→ mEq

37. Choose the word that matches the following definition "a unit of mass
which is equal to 1/1000th of a kilogram"
44
→g

38. Choose the word that matches the following definition "a measure of
volume equal to the amount a standard teaspoon can hold"

→ tsp

39. Choose the word that matches the following definition "a measure of
volume equal to the amount a standard tablespoon can hold or about three
teaspoons"

→ Tbsp

40. Please put 2 _____ (s) of cleaning solution in each ear. Use a dropper.

→ drop

41. Half a liter is equal to 500 ___ml___ (s)

→ ml

42. One thousand ___g___ (s) make up one kilogram

→g

43. To ___administer___ medicine is to give it to a patient.

→ administer

44. A(n) ______ is the correct amount and frequency of medicine to give to a
person.

→ dosage

45. A(n)___IV___ is a method of administering medicine into a vein using a


syringe, often over a long period of time.

→ IV

46. A(n)___IM___ injection is a medicine that is injected into a muscle with a


syringe.

→ IM

47. If medicine is given ___P.O___, it is taken orally, or through the mouth.

45
→ P.O

48. If a medicine is given ___P.R___, it is taken through the rectum.

→ P.R

49. A __route of administration____ is the path by which a medicine is


taken into the body.

→ route of administration

50. If a medicine is ______, it is injected into the fatty layer under the skin
with a syringe.

→ SQ (Subcutaneous injection)

51. If a medicine is taken ______, it is given beneath the tongue

→ SL (sublingually)

52. If a medicine is ______, it is applied to a certain part of the surface of the


body.

→ topical

53. Choose the word that matches the following definition "injected into the
fatty layer under the skin with a syringe"

→ subcutaneous (Subcutaneous injection)

54. Choose the word that matches the following definition "taken orally, or
through the mouth"

→ P.O

55. Choose the word that matches the following definition "given beneath the
tongue"

→ sublingual

56. Choose the word that matches the following definition "taken through the
rectum"

→ P.R

46
57. Choose the word that matches the following definition "injection into a
vein using a syringe, often over a long period of time"

→ IV

58. Choose the word that matches the following definition "applied to a
certain part of the surface of the body"

→ topical

59. Is the ______ for this medicine sublingual or P.O ?

→ route of administration

60. Please get me a syringe so I can give this ______.

→ intramuscular injection

61. How should we ______ Mr. Smith’s medicine?

→ administer

62. For this patient, the correct ______ is 200 milligrams per day.

→ dosage

63. QH means: → given every hour

64. If something is ______, it is happening at the present time.

→ current

65. Choose the word or phrase that matches the following definition: "an
illness that causes discomfort in the head and body"

→ cold

66. Fatigue is a ______ of the flu.

→ symptom

67. Choose the word or phrase that matches the following definition: "the first
instance of something"

→ onset

68. The patient's ______included her previous surgeries .

47
→ past medical history

69. A(n) ______ is a patient’s record of lifestyle and personal details, such as
occupation and marital status.

→ social history

70. If a medication is given ______, it is given three times per day.

→ TID

71. A ______ is a feeling or physical change that indicates illness.

→ symptom

72. A ______ is an illness that can cause coughing, a runny nose, and a sore
throat.

→ cold

73. If a medication is given ______, it is given immediately.

→ stat

74. If a medication is given ______, it is given after meals.

→ pc

75. According to the thermometer, the patient has a ______

→ fever

76. If something is ______, it has liquid flowing or leaking out of it.

→ runny

77. The pain in my back ______

→ throbs

78. TID means: → given three times per day

79. To ______ is to force air loudly through the throat because of an illness or
throat irritation.

→ cough

48
80. Choose the word or phrase that matches the following definition: "a pain
or illness reported by a patient"

→ complaint

81. If a medication is given ______, it is before meals.

→ ac

82. _____ is a viral illness that can cause fevers, aches, and wheezing,

→ flu

83. The patient should take this medication before he eats. The underlined part
has the same meaning as:

→ ac

84. To ______ is to have pain that comes and goes very quickly.

→ throb

85. Choose the word or phrase that matches the following definition: "a
medical treatment"

→ procedure

86. A(n) ______ is pain or illness reported by a patient.

→ complaint

87. If a medication is given ______, it is given every hour.

→ qh

88. QID means: → given four times per day

89. If a medication is given ______, it is given twice per day.

→ BID

90. You should take this antibiotic when you go to bed. The underlined part
has the same meaning as:

→ qhs

91. PRN means: → given as needed

49
92. The patient's ______ condition was caused by a recent injury.

→ current

93. A ______ is an illness that causes body temperature to rise

→ fever

94. If a medication is given ______, it is given four times per day.

→ QID

95. To ______ is to breathe with difficulty in a noisy manner.

→ wheeze

96. A(n) ______ is a medical treatment performed by a doctor or surgeon.

→ procedure

97. I need 50 cc's of lidocaine immediately! The underlined part has the same
meaning as:

→ stat

98. If a medication is given ______, it is given every other day.

→ QOD

99. The patient's ______ included her occupation.

→ social history

100. Choose the word or phrase that matches the following definition: "a
record of a patient’s family’s conditions"

→ family medical history

101. Medical professionals take medical histories to ______ information that


might help with diagnoses.

→ uncover

102. Choose the word or phrase that matches the following definition: "to
breathe noisily and with difficulty"

→ wheeze

50
103. f a medication is given ______, it is given at bedtime.

→ qhs

104. ______ is a collection of information.

→ data

105. If a medication is given ______, it is given as needed.

→ PRN

106. Paul's family has a ______ cancer.

→ history of

107. Choose the word or phrase that matches the following definition: "a
collection of information"

→ data

108. A(n) ______ is a record of the medical conditions of a patient’s family


that might affect the patient’s health.

→ family medical history

109. If someone has a ______ something, he or she has experienced it


regularly or repeatedly.

→ history of

110. QOD means: → given every other day

111. Take two of these after you eat. The underlined part has the same
meaning as:

→ pc

112. Helen was coughing because of the ______

→ flu

113. BID means: → given twice per day

114. Choose the word or phrase that matches the following definition: "having
liquid leaking from something"

51
→ runny

115. A(n) ______ is a medical condition that causes a reaction or illness when
someone comes in contact with a particular substance.

→ allergy

116. Choose the word or phrase that matches the following definition: "to
force air loudly through the throat"

→ cough

117. A(n) ______ is a patient’s record of previous illnesses, procedures, and


other medical details.

→ past medical history

118. A(n) ______ is the start or first instance of something.

→ onset

119. You will need to take a pill once every hour until you start to feel better.
The underlined part has the same meaning as:

→ qh

120. A(n) ______ is a measure of heartbeats in a given period of time. One


way to take this measurement is to place the fingers over a major artery in
the neck, wrist, or other location and press them against a bone to feel the
palpations of the heart as blood moves through the artery.

→ pulse

121. ______ is the examination of something by touch.

→ palpitation

122. A(n) ______ is a test that examines a urine sample.

→ urinalysis

123. Choose the word or phrase that matches the following definition: "a waste
product found in blood that the kidney usually removes"

→ creatinine

52
124. Get a(n) ______of that patient’s heart activity.

→ ECG

125. Which of the following is NOT an aspect of checking vital signs?

→ evaluating posture

126. A ______ (BUN) test is a test to determine the amount of urea nitrogen in
the blood.

→ blood urea nitrogen

127. If something is ______, it is related to the kidneys.

→ renal

128. Choose the word that is similar in meaning to the underlined part.
The nurse forgot to determine the quality of the patient’s posture.

→ evaluation

129. ______ is a type of protein found in the body.

→ albumin

130. A(n) ______ is something that someone notices, or the act of noticing
something.

→ observation

131. A(n) ______ (ECG)is a measurement of the electrical activity of the heart
over a period of time. → electrocardiogram

132. Choose the word or phrase that matches the following definition: "a
medical imaging technique that uses the reflection of sound waves to
produce an image of the body"

→ ultrasound

133. Choose the word or phrase that matches the following definition: "a type
of protein found in the body"

→ albumin

53
134. To ______ something is to determine the qualities of its condition or
state.

→ evaluate

135. Which of the following is an advanced medical imaging technique?

→ CT scan

136. Which of the following is an aspect of checking vital signs?

→ auscultation

137. Choose the word that is similar in meaning to the underlined part.
The doctor performed an investigation of the patient’s ear.

→ inspection

138. A(n) ______ is a form of medical imaging that uses many


twodimensional X-rays to create a three-dimensional image of an object.

→ CT scan

139. People can have a relatively normal life with just one ______.

→ kidney

140. Choose the word or phrase that matches the following definition: "a thin,
tubular instrument used to examine the inside of an organ or body cavity"

→ endoscope

141. A(n) ______ is an organized examination of a patient’s physiological


state as compared to what is understood to be normal.

→ inspection

142. Choose the word or phrase that matches the following definition: "a test
that examines a urine sample"

→ urinalysis

143. ______ is the conveyance of information about a person’s physiological


or emotional state by the way he or she moves.

→ body language

54
144. Which of the following is NOT an advanced medical imaging technique?

→ X-ray

145. The bone is likely broken, but take a(n) ______ to make sure.

→ X-ray

146. The doctor will ______ a tube into the man’s chest to see pictures with
the endoscope.

→ injection

147. We will remove some tissue from your liver during the ______.

→ biopsy

148. Choose the word that is similar in meaning to the underlined part.
The patient’s back pain seemed to make a difference upon her mood

→ affect

149. Which of the following is a physical examination technique?

→ auscultation

150. Which of the following is an advanced medical imaging technique?

→ ECG

151. Apply this ______to the area before using the ultrasound machine.

→ gel

152. To ______ something such as mood is to bring about a change in it.

→ affect

153. Your ______ reading, at 110/65, is on the low end of the normal range.

→ blood pressure

154. Choose the word or phrase that matches the following definition: "the use
of X-rays to view images of the internal human body"

→ radiography

55
155. Choose the word or phrase that matches the following definition: "a
medical condition in which a person loses kidney function over time"

→ chronic kidney disease

156. Which of the following is a physical examination technique?

→ percussion

157. ______ is a semi-solid substance placed between the patient’s skin and an
ultrasound probe.

→ gel

158. The ______ will show the results from several tests.

→ pathology report

159. A(n) ______ is a thin, tubular instrument used to examine the inside of an
organ or body cavity.

→ endoscope

160. A(n) ______ is a report that discusses what was found after cells and
tissue were examined.

→ pathology report

161. Choose the word or phrase that matches the following definition: "a test
to determine the amount of urea nitrogen in the blood"

→ BUN test

162. Which of the following is a physical examination technique?

→ palpitation

163. ______ are statistical measures of essential body functions such as


temperature, pulse rate, blood pressure, and respiration. VITAL SIGNS

164. Which of the following is an aspect of checking vital signs?


CHECKING PULSE

165. ______ is the use of x-rays to view images of the internal human body.
RADIOGRAPHY

56
166. Choose the word or phrase that matches the following definition: "a form
of medical imaging that uses many twodimensional X-rays to create a
three-dimensional image of an object". CT SCAN

167. A(n) ______ (MRI) is a medical imaging technique that uses magnetic
forces on atoms to produce an image of the body. MAGNETIC
RESONANCE IMAGING

168. ______ is a waste product found in blood that the kidney usually
removes. CREATININE

169. Which of the following is an advanced medical imaging technique? MRI

170. Choose the word that is similar in meaning to the underlined part.
Through watching carefully the doctor noticed that the patient was
limping. OBSERVATION

171. A ______ tests how well kidneys are working. GFR TEST

172. Choose the word or phrase that matches the following definition: "a
yellow liquid waste product that the body produces" URINE

173. A(n) ______ is a medical procedure in which a piece of tissue is removed


and examined to help determine an illness. BIOPSY

174. What is one use for percussion techniques? TO CHECK THE


CONDITION OF INTERNAL ORGANS

175. Choose the word or phrase that matches the following definition: "a
medical imaging technique that uses magnetic forces on atoms to produce
an image of the body" MRI

176. ______ is the act of tapping on an area of the body such as the chest or
abdomen to determine the condition of the underlying bone or tissues.
PERCUSSION

177. Who is most likely to be examined by an ultrasound? A PATIENT


WHO IS PREGNANT

178. Which of the following is an aspect of checking vital signs? TAKING


TEMPERATURE

57
179. A(n) ______ is a medical imaging technique that uses the reflection of
sound waves to produce an image of the body. ULTRASOUND

180. A ______ (GFR) test is a test to determine how much kidney function a
person has. GLOMERULAR FILTRATION RATE

181. A(n) ______ is a form of radiation that can be used to take pictures of the
internal human body) X-RAY

182. ______ is the examination of something by listening with or without an


instrument such as a stethoscope. AUSCULTATION

183. If one or both kidneys decline in function you may have ______ failure.
RENAL

184. ______ (CKD) is a medical condition in which a person loses kidney


function over time. CHRONIC KIDNEY DISEASE

185. ______ is a measure of the pressure with which blood moves through the
body. BLOOD PRESSURE

186. ______department compounds the raw materials into drugs, packages


them, and pút in the leaflets for patients. PRODUCTION

187. ______department finds new substances to make new drug formulations


or changes existing dosage form, for example, from tablets to capsules.
RESEARCH AND DEVELOPMENT (R&D)

188. ______department compiles the drug documentation and submits it to the


drug regulatory authorities so company can get authorization to market the
product. REGULATORY AFFAIRS

189. Regulatory Affairs department compiles drug documentation and submits


it to the drug regulatory authorities so the company can get ______
AUTHORIZATION TO MARKET THE PRODUCT

190. ______department plans the promotion and distribution of drugs which


will be launched, and makes decisions about the packaging or tablet colour
of new products. MARKETING AND SALE

191. Marketing and sale department plans ______ of drugs which will be
launched, and makes decisions about the packaging or tablet colour of new
products. THE PROMOTION AND DISTRIBUTION

58
192. ______department tests or organizes testing on live subjects, and makes
sure that the drugs are safe and effective for the patients. CLINICAL
AFFAIRS

193. ______department ensures that product meet the standards whch the law
requires, and contain the active ingredients advertised. QUALITY
ASSURANCE (QA)

194. Quality Assurance (QA) department ensures that products meet the
standards which the law requires, and contain the ______ advertised.
ACTIVE INGREDIENTS

195. Dosage form is the final form of the medicine, e.g. Tablet, powder, gel,
spray, etc. DOSAGE FORM

196. ______ form is the final form of the medicine, e.g. Tablet, powder, gel,
spray, etc. DOSAGE

197. ______ is a product which can be sold without the patient seeing a doctor.
OVER-THE-COUNTER DRUG

198. ______are future drugs, not yet on the market. PHARMACEUTICAL


PRODUCTS IN THE PIPELINE

199. Pharmaceutical products in the______are future drugs, not. PIPELINE

200. ______is the medicine bought in a pharmacy and requiring a written note
form the doctor. PRESCRIPTION DRUG

201. ______drug is the medicine bought in a pharmacy and requiring a written


note form the doctor. PRESCRIPTION

202. A ______ collects drug safety information after approval and reports any
serious adverse events to the health authorities.
PHARMACOVIGILANCE MANAGER

203. ______ performs clinical trials. ______ must also summarize, interpret
and process clinical data. CLINICAL RESEARCH ASSOCIATE

204. Clinical research associate performs ______ . Clinical research associate


must also summarize, interpret and process clinical data. CLINICAL
TRIALS

59
205. ______ operates complex scientific instruments and performs tests to
determine whether ingredients in liquids, powders, or tablets meet
requirements. LABORATORY TECHNICIAN

206. Laboratory technicians ______ complex scientific instruments and


performs tests to determine whether ingredients in liquids, powders, or
tablets meet requirements. OPERATE

207. It’s the ______’s job to research, write, and edit clinical and study reports
before the pharmaceutical company submits them to regulatory authorities.
The ______ summarizes and interpret clinical data. MEDICAL WRITER

208. It’s the Medical writer’s job to ______ clinical and study reports before
the pharmaceutical company submits them to regulatory authorities.
RESEARCH, WRITE, AND EDIT

209. A ______ co-ordinates and manages the cross-functional teams that


develop and launch a drug. PROJECT MANAGER

210. A Project manager ______ and manages the cross-functional teams that
develop and launch a drug. COORDINATES

211. A ______ is personally responsible for the quality of each product that
leaves the product line. QUALIFIED PERSON

212. A ______ is personally responsible for the quality of each product that
leaves the product. He must manage all the processes in production, QA,
and the labs to make sure Standard Operating Procedures are followed.
QUALIFIED PERSON

213. ______ (SOPS) means a description of a working method or process.


STANDARD OPERATING PROCEDUERS

214. ______ are rules or laws about health. HEALTH REGULATIONS

215. ______’s job is to make sure that suitable, clean containers are used to get
the product from the company to the patient. PACKAGING
TECHNICIAN

216. ______ is an oily substance like a cream. OINTMENT

217. ______ stands for bachelor’s degree. B.S

60
218. ______ stands for bachelor of science degree. BSc

219. In the UK, to become fully qualified, pharmacists have to take an


examination to get a ______ to practice pharmacy. LICENSE

220. I______ my PhD in Pharmaceutical Chemistry at Monash University.


GOT/RECEIVED/OBTANIED

221. But first, here is ______ . The feasibility study has just been successfully
completed. AN UPDATE THE PROJECT

222. The main reason I am writing to you is to get your input on a new
product. ______ we plan to market a new prescription drug for headaches.
AS YOU KNOW
I ______ Johnson & Johnson in their clinical department. UESD TO
WORK AT

223. I ______ a first line worker and worked my way up to. STARTED AS

224. To self-medicate means: TO TAKE MEDICINE WITHOUT


SEEKING ADVICE OF A HEALTHCARE PROFESSIONAL

225. CRO ______ someone to co-ordinate and perform analytical testing for
stability studies of new products. IS RESEARCHING FOR

226. ______ is a medication to reduce or eliminate pain. ANALGESIC

227. All of the following are non-production pharmaceutical professions,


EXCEPT?. LINE WORKER

228. Which of the following is NOT a form of pharmaceutical documentation?


MARKETING CLAIMS

229. The feasibility study has just been successfully______. COMPLETED

230. I worked my way ______ to project manager. UP

231. Before we close, ______ to review the action points. I WOULD LIKE

232. We will need to fill the position of clinical trial manager shortly. I’d
appreciate it if you could write up a job ______ with the input below and
place it in the pharmaceutical journal we normally use.
ADVERTISEMENT

61
233. We test or organize testing on live subjects and make sure that our drugs
are safe and ______ for the patients. EFFECTIVE

234. ______ is a substance in a drug. INGREDIENT

235. Regulatory affairs department compiles the drug documentation and


submits it to the drug regulatory authorities so the company can get
authorization to ______ the product. MARKET

236. Since the ______ of our successful feasibility study, we have also
obtained very encouraging preclinical data (=end). CONCLUSION

237. Since the conclusion of our successful feasibility study, we have also
obtained very ______ preclinical data. ENCOURAGING

238. Feasibility study is a(n) ______to determine the advantages, practicality,


and profitability of a proposed project. INVESTIGATION

239. Feasibility study is an investigation to ______ the advantages,


practicality, and profitability of a proposed project. DETERMINE

240. A(n) ______ is a short official note that is sent by one person to another
within the same company or organization. MEMO

241. ______ is a dry substance in the form of very small grains. POWDER

242. Ointment is a(n) ______ substance like a cream. OILY

243. I operate complex scientific instruments and perform test to determine


whether ingredients in liquids, powder, or tablets ______. MEET
REQUIREMENTS

244. According to European law, a qualified person is responsible for the


quality of each product that leaves the ______. PRODUCTION LINE

245. I ______ complex scientific instruments and perform test to determine


whether ingredients in liquids, powder, or tablets meet requirements.
OPERATE

246. I was involved in the initial ______ design phase, the planning and
building of our new pharmaceutical facility in Shanghai, and now I am the
plant manager. CONCEPTUAL

62
247. I received my master’s ______ at New York University and licence to
practice pharmacy in the United States. DEGREE

248. With your input, I’ll be able to ______ the timelines for planning and
implementation and decide on milestones before out next meeting.
FINALIZE

249. You need to be able to write scientifically and technically ______


protocols in English. ACCURATE

250. Unlike in many countries, you’ll also find many cheerful, bright coloured
ads in magazines, which promote ______ and other prescription drugs in
US. ANTI-DEPRESSANT

251. In Europe, the strength of medicine varies ______ depending on what


health authorities allow. CONSIDERABLY

252. In France, medicines should not only ______ a disease, but also look
fresh and interesting. CURE

253. Some companies are successful at marketing their drugs all over the
world without making any major changes to them. Others have different
formulations, advertising, and packaging in each country, due to
differences in ______ and law. CUSTOMS

254. In an R & D meeting, John gives the following answer:”It is already


available in lozenge and chewing gum form, but we hope to develop a
time-release patch in the near future”. What question did John answer?
WHAT KIND OF FORMULATION COULD WE DEVELOP FROM
THIS NCE?
255. Patches are easy to ______, not too expensive, and can be placed right at
the point of pain. APPLY
256. One of criteria to obtain the status of OTC product in the US is that a
medication must have low ______ of side effects. INCIDENCE
257. ______ is the path by which a drug, fluid, poison, or other substance is
taken into the body. ROUTE OF ADMINISTRATION
258. To obtain the status of a non-prescription or OTC in the US, a drug must
have ______ . A LARGE MARGIN OF SAFETY
259. If you have a ___ when you are ill, your body Temperature is higher than
usual. FEVER

63
260. Mensamint is a new dosage form of Mensadent. Known side effects
often include loss of sleep if taken in the late afternoon or evening. ____ (
now and then ), an increase in blood pressure may develop.
OCCASIONALLY
261. Common ____ of CAREFREEDO are: nausea, vomiting, abdominal
pain. SIDE EFFECTS
262. ___ is the process of testing chemical compounds, with the goal of fiding
a substance which has a beneficial effect on a targeted disease.
RESEARCH
263. OTC Pharmaceutical products must have labelling that provides aquadate
___ for sale and effective use. DIRECTIONS
264. ____ is a container with a liquid that is administered in spray form.
AEROSOL
265. Sublingual tablet is administered by placing it ____ . UNDER THE
TONGUE
266. Choose the CORRECT statement about drug categories THE US HAS
TWO OFFICIAL CATEGORIES: PRESCRIPTION DRUGS AND OTC
DRUGS
267. Which one of the following is NOT a route of administration?
DISSOLUTION
268. Take these _____ three times a day with meal. PILLS
269. _____ is the study of the bodily absorption, distribution, metabolism, and
excretion of drugs (what the body does to the drug).
PHARMACOKINETICS
270. Dosage is the ____ AMOUNT AND FREQUENCY OF A MEDICINAL
DRUG THAT MAY BE TAKEN SAFRLY
271. A/an ____ a solid preperation that is intended to dissolve or disintegrate
slowly in the mouth. LOZENGE
272. Someone who suffers from insomina ____. FINDS IT DIFFICULT TO
SLEEP.
273. Bronchitis is the _____ of the bronchial tubes, characterized bu coughing,
difficulty in breathing. INFLAMMATION.
274. ____ is the degree to which a substance can harm humans or animals.
TOXICITY
275. A/an____ is a type of topical dosage forms. CREAM
276. Scientists have made a major ___ in the treatment of cancer.
BREAKTHROUGH

64
277. An aerosol is a type of _____ dosage forms. INHALED
278. _____ capsule is a type of capsule that is usually used to contain
medicine in the form of dry powder or very small pellets. HARD
GELATIN
279. A/an ______ is a liquid in which another substance has been dissolved.
SOLUTION
280. ____ is the study of drugs, how they work, and what they do in the body.
____ can be divided into two separate areas. Pharmacodynamics and
Pharmacokinetics. PHARMACOLOGY
281. _____ is a solid medicine which melts slowly in the rectum or vagina.
SOPPOSITORY
282. Anaemia is ____ A MEDICAL CONDITION IN WHICH THERE ARE
TWO FEW RED CELLS IN YOUR BLOOD, CAUSING YOU TO FEEL
TIRED AND LOOK PALE.
283. _____ is an expert in chemistry. In the UK, this word is also used for the
person who preapres and sells medicine, also known as a pharmacist in the
US. CHEMIST
284. ______capsule is a type of capsule that is usualy used to caintain oils and
for active ingredients that are dissolved or suspended in oil. SOFT
GELATIN
285. _____ is the process of carrying forward scientific discoveries made
during the research process, with the goal of producing a marketable drug.
DEVELOPMENT
286. ____ is the study of poison. TOXICOLOGY
287. ____ refer to a group of diseases that affect how your body uses blood
sugar. (glucose) DIABETES
288. _____ is an expert in the science of poisons. TOXICOLOGIST
289. A/an ____ is a type of inhaled dosage forms. AEROSOL
290. Someone who suffers from ____ finds it difficult to sleep. INSOMNIA
291. You were asked to give your opinion about the in-man studies of a new
drug. Choose the INCORRECT sentence: ACCORDING TO ME, THE
IN-MAN STUDIES FOR THIS DRUG WILL TAKE MORE THAN SIX
MONTH
292. Medication must been four criteria in order to abtain the status of a non-
presription or over-the counter (OTC) product. Choose the CORRECT
statement: IT MUST HAVE LOW INCIDENCE OF SIDE EFFECTS

65
293. _____ is a condition in which faeces are discharged from the bowels
frequently and in a liquid form. DIARRHOEA
294. A specialist or ____ in the scientific filed of chemistry is called a chemist.
EXPERT
295. _________ is an oily liquid to rub on painful body parts to reduce pain.
LINIMENT
296. Mensamint is a new dosage form of Mensadent (_______ with plysician’s
presciption only) OBTAINABLE
297. Behind-the-counter medicine _____ CAN BE PURCHASED WITHOUT
A PRESCIPTION BUT ONLY WITH THE PERSONAL
INVOLVEMENT OF A PHARMACIST.
298. A cream is a type of _____ dosage forms. TOPICAL
299. ________is the amount and frequency of a medicinal drug that may be
taken safely. DOSAGE FORM
300. If you have _______, you have pain in your stomach and chest that are
caused by difficulties in digesting food. INDIGESTION
301. Suppository is a solid medicine which _____(s) slowly in the rectum or
vagina. MELT
302. ______ medicine can be perchased withou a presciption but only with the
personal involvement of a pharmacist. BEHIND-THE-COUNTER
303. Medication must meet four criteria in order to abtain the status of a non-
prescription or over-the-counter (OTC) product. Choose the CORRECT
statement: IT MUST HAVE A LARGE MARGIN OF SAFETY
304. When substances are taken with alcohol or antibiotics, their chemical
form could change and even cause harmful side effects. SIDE EFFECTS
305. Using the right______ is especially inportant when givinig medicine to
children, because they often have problems swolling pills. DOSAGE
FORM
306. A/an ____ a semi-solid, smooth greasy preparation for application to the
skin for healing. OINTMENT
307. When substances are taken with alcohol or antibiotics, their chemical
form could change and even cause ______ side effects (=bad) HARMFUL
308. Liminent is _____ AN OILY LIQUID TO RUB ON PAINFUL BODY
PARTS TO REDUCE PAIN
309. ________ is the study of physiological effects of drugs and the
mechanisms of their actions (what the drug does to the body)
PHARMACODYNAMICS

66
310. _______ is a unique, pharmacologically active product that has never
previously been synthesized or used to treat disease. NEW CHEMICAL
ENTITY
311. _________ia a medical condition in which there are too few red cells in
your blood, causing you feel tired or pale. ANAEMIA
312. Why do operational methods and procedures have to be validated? TO
COMPLETE THE QUALITY ASSURANCE PROCESS
313. Standard operating procedures (SOPs) are written and used by companies
to make it easier for them to follow GxP. These are set of written
instructions to ______ performance and results MAINTAIN
314. CAPA stands for ________. It is a part of the overall Quality
Management System (QMS) required for GMP. CORECTIVE
ACTION/PREVENTVE ACTION
315. CAPA stands for CORECTIVE ACTION/PREVENTVE ACTION. It is a
part of the overall ____________ (QMS) required for GMP. Quality
Management System
316. In the Pharmaceutical industry, GDP stands for _____ GOOD
DOCUMENTATION PRACTICE
317. Proper protective clothing must be ____ at all times. WORN
318. Standard operating procedures are regularly _____ UPDATED
319. Standard operating procedures (SOPs) are _______ on a regular basis,
often after an audit has been carried out. UPDATED
320. Why is product sampling carried out? TO CHECK PRODUCT
QUALITY
321. Any observation or _____ noted by the auditors is categorized as either
major, minor, or critical. FIDING
322. A holistic approach looks as aspects of a pharmaceutical company
______ to make sure that the entire process meets high industry standards.
TOGETHER
323. Why do operational methods and procudures have to be validated? TO
COMPLETE THE INSPECTION PROCESS
324. What are the clothing guidelines for lab technicians? PROTECTIVE
CLOTHING MUST BE WORN AT ALL TIMES.
325. Choose the CORRECT statement about Quality assurance and auditing.
PROPER DOCUMENTATION NOT ONLY ENABLES
TRACEABILITY, BUT ALSO ALLOWS A COMPLETE PRODUCT
RECALL FROM THE MARKET, IF NECESSARY.

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326. Even a product that has been marketed for years might have to be _____
the market in a product recall if serious adverse reaction occur. TAKEN
OFF
327. A few years ago, a well-known European pharmaceutical company was
force to recall one of its drugs due to claims of product contamination. The
drug manufacturer was unable to say just how many patients were taking
this drug at the time. However, it estimated the ____ figure at over 40,000
people. GLOBAL
328. Choose the correct phrase to state the reason for the memo. THIS
MEMO IS TO ADVISE YOU THAT….
329. A/an _____ is a distinctive unpleasant smell. ODOUR
330. _______ (QMS) is a formalized system that document processed,
procedures, and responsibilities for achieving quality policies and
objectives. QUALITY MANAGEMENT SYSTEM
331. You are writing the SOP guideline to tell your employee to “perform all
work with virus-infected animals in the bio-safety cabinet” . The correct
SOP guideline is: ALL WORK WITH VIRUS-INFECTED ANIMALS
MUST BE PERFORMED IN THE BIO-SAFETY CABINET
332. Why is product sampling carried out? TO MAKE SURE SOPs ARE
FOLLOWED
333. A(n) _______ is a safety device consists of a sheet of a fire retardant
material which is placed over a fire in order to extinguish it. FIRE
BLANKET
334. Choose the correct phrase to ask for verification of some information.
PLEASE CONFIRM….
335. Inspection and validation are required to prove that the manufacturing
and testing equipment is ______ FUNCTIONAL
336. A_________ considers laboratory and manufacturing processes and
environments together and not individually. HOLISTIC APPROACH
337. Choose the word means :”No longer pure” CONTAINMINATED
338. Choose the word that match the following defination: “Practice of
checking that goods and services follow standards” . QA
339. According to report, it seems that an unanticipated ______ between the
drug’s active ingredient and the chemicals used as part of the cleaning
processes at the site wa the cause if the contamination. REACTION
340. In the Pharmaceutical industry, stands for _____ GOOD CLINICAL
PRACTICE

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341. Even a product that has been marketed for years might have to be taken
off the market in a _____ if serious adverse reactions occur. PRODUCT
RECALL
342. An internal _____ involves inspection and validation of operational
methods, procedures, equipment to ensure functionality, accuracy and
validity. AUDIT
343. CAPA is a part of the overall Quality Management System (QMS)
required for GMP. _____ prevents recurrence of errors. CORRECTIVE
ACTION
344. An annual audit of safety procedures in all laboratories is carried out
____ EVERY 12 MONTHS
345. __________ make sure that the health and well-being of laboratory
workers are guaranteed. SAFETY PROCEDURES
346. A genotoxic substance is ______ A CHEMICAL THAT DAMAGES
CELLULAR DNA, RESULTING IN MUTATIONS OR CANCER.
347. An internal audit involves inspection and ______ of operational methods,
procedures, equipment to ensure functionality, accuracy and validity.
VALIDATION
348. A few years ago, a well-known European pharmaceutical company was
forced to ____ one its drugs due to claims of product contamination.
RECALL
349. ________ a/an apparatus to wash the eyes after exposure to chemical
contamination. EYE PATH
350. ______ involves all manufacturing processes in GMP which make sure
the good produced are kept high standards. QUALITY ASSURANCE
351. Documentation is important and necessary at every step of the processes,
activities, and ____(s) involved in drug manufacturing. OPERATION
352. All operational methods and proceudures must also be inspected for ____
ACCURACY
353. _____ is important and necessary at every step of the processes,
activities, and operation involved in drug manufacturing.
DOCUMENTATION
354. You need to _____ all equipment following any experiments with
laboratory animals. DISINFECT
355. Please make sure that all the laboratory staff are advised and prepared
_____ standard audit procedure. IN ACCORDANCE WITH

69
356. Which aspect of drug manufacturing enables traceability?
DOCUMENTATION
357. In the Pharmaceutical inductry, GRP stands for ____ GOOD
RESEARCH PRACTICE
358. At the end of every stage of a product’s manufacturing process, ______ is
done to maintain quality standards. ENDPOINT TESTING
359. Corrective action _____ PREVENT RECURRENCE OR ERRORS
360. The quality assurance _______ in good manufacturing practice (GMP)
includes product quality control, sampling, and testing. PROCESS
361. Manufacturing processes and procedures must go through periodic
_______ to guarantee that they are still of an acceptable standard.
VALIDATION
362. This memo is _____ you that your department has been scheduled for a
periodic audit of the laboratory safety systems and procedures. TO
ADVISE
363. To _______ something means to make it easier to understand, usually by
explaining it in more detail. CLARIFY
364. This memo is to ______ you that your department has been scheduled for
a periodic audit of the laboratoy safety systems and procedures. ADVISE
365. Safety procedures guarantee the _____ of lab workers. HEALTH
366. We should tell the lab staff to _____ that all the labs are spotlessly clean
and that all lab devices and equipment are where they should be – at every
single workstation. DOUBLE-CHECK
367. Please comfirm _____ of this memo and send us a copy of all your
correspondence with regard to this scheduled audit. RECEIPT
368. _________ involves all manufacturing processes in GMP which make
sure the goods produced are kept at high standards. QUALITY
ASSURANCE
369. A gas mask is a device that your wear over your face in order to protect
yourself from ____ POISIONOUS GASES
370. Choose the word that match the following definition: “A written
desciption of a working method”. SOP
371. The completed checklist and original audit results will be _______ with
you and the Research and Development Vice President. REVIEWED
372. Preventation action ______. PREVENT OCCURANCE OF ERRORS
373. In the Pharmaceutical industry, GSP stands for ______ GOOD SAFETY
PRACTICE.

70
Session 1.

1. If a medicine is given _____ (per rectum), it is taken through the rectum.

A. P.R.
71
B. P.O.
C. WNL
D. o/e

2. (sublingual) – Medicine that is given beneath the tongune.

A. SQ.
B. SL
C. WNL
D. Dx

3. A measure of volume equal to the amount a standard teaspoon can hold, on


almost five milliliters.

A. cubic centimeter (cc)


B. teaspoonful (tsp)
C. milliliters (ml)
D. tablesspoonful (Tbsp)

4. If a function is ____ (Within Normal Limits), it is operating in a normal


range.

A. WNL
B. o/e
C. c/o
D. P.O.

5. The parth by which a medicine is taken into the body.

A. ounce (oz)
B. milliequivalent ( mEq)
C. cubic centimeter (cc)
D. route of administration

6. (treatment/ prescription) is the specific drug or course of action prescribed to


treat a patient’s medical condition.

A. HR
B. Rx
C. IM
D. Dx

72
7. A unit of mass equal to one thousandth of a gram.

A. ounce (oz)
B. milligram (mg)
C. gram (g)
D. milliliters (ml)

8. Drops of liquid administered to the eye.

A. SOB
B. HTN
C. drop (gtt)
D. gtt

9. A unit of liquid volume equal to the amount of liquid which comes from a
dropper, or about 1/12th of a milliliter.

A. gram (g)
B. drop (gtt)
C. ounce (oz)
D. milliliter (g)

10. (subcutaneous) A medicine that is injected into the fatty layer under the skin
with a syringe.

A. IM
B. SOB
C. SQ
D. SL

11. (hypertension) is having blood pressure that is higher than normal.

A. gtt
B. WNL
C. HTN
D. o/e

12. An intravenous injection is a method of administering medicine into a vein


using a syringe, often over a long period of time.

A. P.R.
B. IM

73
C. P.O.
D. I.V.

13. A unit of mass which is equal to one-thousandth of a kilogram.

A. gram (g)
B. microgram (mcg)
C. milligram (mg)
D. kilogram (kg)

14. A unit of volume equal to a cube whose sides are equal to one centimeter.

A. drop (gtt)
B. microgram (mcg)
C. milliliter (ml)
D. cubic centimeter (cc)

15. (Diagnosis) is the positive identification of a patient’s disease or ailment.

A. Rx
B. IM
C. SQ
D. Dx

16. (Heart Rate) is the frequency with which a person’s heart beats in a given
amount of time. It is usually expressed in beats per minute.

A. Dx
B. HTN
C. HR
D. Rx

17. (Blood Pressure) is the force exerted by circulating blood on the walls of
blood vessels. It is a vital sign that medical professionals use to determine
whether body systems are operating as they should.

A. HR
B. XR
C. BP
D. Rx

18. Medicine is applied to a certain part of the surface of the body.

74
A. topical
B. P.R.
C. P.O.
D. dosage.

19. An X-ray is a visual image of all or part of the body acquired with special
equipment using electromagnetic radiation to see bones and ohter internal
aspects of the body.

A. Rx
B. BP
C. HR
D. XR

20. If medicine is given ___ (by mouth), it is taken orally, or through the mouth.

A. P.O.
B. o/e
C. topical
D. P.R.

21. A unit of weight equal to 1/16th of a pound.

A. microgram (mcg)
B. milligram (mg)
C. ounce (oz)
D. gram (g)

22. If a patient ___ (complains of) something, he or she describes symtoms that
are painful or uncomfortable.

A. c/o
B. WNL
C. P.R.
D. o/e

23. the correct amount and frequency of medicine to give to a person.

A. o/e
B. gram (g)
C. dosage
D. topical

75
24. If something is found ___ (on examination), it was discovered during an
exam.

A. P.O.
B. WNL
C. c/o
D. o/e

25. A unit of mass equal to one millionth of a gram.

A. milliliter (ml)
B. milligram (mg)
C. microgram (mcg)
D. gram (g)

26. (temperature) is a quantitative measurement of heat within the body. It is


can be used, in part, to gauge whether the body is operating normally.

A. T
B. XR
C. HR
D. Rx

27. (Short of Breath) is a condition in which a patient finds it more difficult to


beathe than usual.

A. c/o
B. HTN
C. SQ
D. SOB

28. A measure of volume equal to the amount a standard tablespoon can hold or
about three teaspoons.

A. teaspoonful (tsp)
B. cubic centimeter (cc)
C. tablespoonful (Tbsp)
D. milliequivalent (mEq)

29. 1/1000th the weight of the minor componet of a chemical solution dissolved
in the major component.

76
A. teaspoonful (tsp)
B. milliliter (ml)
C. tablespoonful (Tbsp)
D. milliequivalent (mEq)

30. To give medicine to a patient.

A. ounce (oz)
B. drop (gtt)
C. administer
D. milliliter (ml)

62 Questions

1. A ____ is 1/1000th the weight of the minor component of a chemical solution


dissolved in the major component.

A. mEq
B. g
C. mcg
D. mg

2. If a patient ____ something, he or she describes symptoms that are painful or


uncomfortable.

A. c/o
B. Dx
C. o/e
D. HTN

3. A ____ is a unit of mass equal to one thousandth of a gram.

A. ml
B. mg
C. mEq
D. mcg

4. For this patient, the correct ____ is 200 milligrams per day.

A. dosage form
B. route of administration
C. route of medication

77
D. dosage

5. Which of the following is equal to one ml?

A. 1 cubic centimeter
B. 1 drop
C. 1 milligram
D. 1 teaspoon.

6. ____ for the infection included antibiotics.

A. HTN
B. WNL
C. Rx
D. XR

7. Choose the word that matches the following definition “a unit of mass equal
to one thousandth of a gram”

A. mg
B. mEq
C. ml
D. mcg

8. Choose the word that matches the following definition “a unit of mass which
is equal to 1/1000th of a kilogram”

A. mg
B. mEq
C. mcg
D. g

9. A(n) ___ injection is a medicine that is injected into a muscle with a syringe.

A. IV
B. P.R.
C. IM
D. SQ

10. ____is having blood pressure that is higher than normal.

A. Dx
B. HTN

78
C. WNL
D. Rx

11. ____ is a visual image of all or part of the body acquired with special
equipment using electromagnetic radiation to see bones and other internal
aspects of the body.

A. Rx
B. HR
C. WNL
D. XR

12. A _____ is a unit of mass which is equal to one-thousandth of a kilogram.

A. g
B. mcg
C. mEg
D. mg

13. Please get me a syringe so I can given this _____.

A. dosage form
B. intramuscular injection
C. pill
D. route of administration

14. Choose the word that matches the following definition “a unit of mass equal
to one millionth of a gram”.

A. mg
B. mEg
C. g
D. mcg

15. Is the _____ for this medicine sublingual or P.O.?

A. route of administration
B. bioavailability
C. dosage form
D. route of medication

79
16. _____- is the frequency with a person’s heart beats in a given amount of
time. It is usually expressed in beats per minute.

A. Rx
B. HR
C. BP
D. Dx

17. If medicine is given ____, it is taken orally, or through the mouth.

A. P.R.
B. P.O.
C. IV
D. SL

18. _____ is a quantitative measurement of heat within the body. It is can be


used, in part, to gauge whether the body is operating normally.

A. Dx
B. c/o
C. T
D. Rx

19. Choose the word that matches the following definition “the number of
heartbeats in a given amount of time”

A. Dx
B. Rx
C. BP
D. HR

20. One thousand _____ (s) make up one kilogram.

A. mcg
B. mEg
C. g
D. mg

21. Choose the word that matches the following definition “ the identification of
an illness or disease”

A. Dx

80
B. Rx
C. BP
D. HR

22. If something is found ____, it was discovered during an exam.

A. o/e
B. SOB
C. WNL
D. c/o

23. A(n) _____ is the correct amount and frequency of medicine to give to a
person.

A. dosage form
B. dosage
C. dose
D. dossier

24. A _____ is a unit of volume equal to a cube whose sides are equalto one
centimeter.

A. mg
B. mEq
C. cc
D. mcg

25. Choose the word that matches the following definition “the amount of force
applied on blood vessel walls by circulating blood”

A. Rx
B. HR
C. BP
D. Dx

26. _____ is the positive identification of a patient’s disease or ailment.

A. HR
B. Rx
C. Dx
D. BP

81
27. A ____ is a unit of liquid volume equal to one thousandth of a liter and
equal to one cubic centimeter.

A. g
B. ml
C. mg
D. gtt

28. Choose the word that matches the following definition “taken through the
rectum”.

A. P.O.
B. IV
C. SL
D. P.R.

29. Choose the word that matches the following definition “applied to a certain
part of the surface of the body”.

A. topical
B. medicine
C. pills
D. sublingual

30. A(n) _____ is a method of administering medicine into a vein using a


syringe, often over a long period of time.

A. IV
B. P.O.
C. IM
D. P.R.

31. If a medicine is given _____, it is taken through the rectum.

A. P.R.
B. P.O.
C. IM
D. SQ

32. The ____ clearly showed that bone was broken.

A. HR

82
B. Rx
C. XR
D. T

33. A _____ is the path by which a medicine is taken into the body.

A. bioavaitability
B. route of medicine
C. dosage form
D. route of administration

34. ___ is the force exerted by circulating blood on the walls of blood vessels.
It is a vital sign that medical professionals use to determine whether body
systems are operating as they should.

A. Dx
B. Rx
C. BP
D. HR

35. Half a liter is equal to 500 ____ (s).

A. ml
B. mg
C. gtt
D. g

36. If a function is ____, it is operating in a normal range.

A. XR
B. WNL
C. HTN
D. Rx

37. To ____ medicine is to give it to a patient.

A. administer
B. admit
C. administration
D. admission

83
38. Choose the word that matches the following definition “a measure of
volume equal to the amount a standard tablespoon can hold or about three
teaspoon”

A. tsp
B. gtt
C. Tbsp
D. mcg

39. Choose the word that matches the following definition “discovered while
investigating a patient’s health”

A. SOB
B. o/e
C. WNL
D. c/o

40. How should we ____ Mr. Smith’s medicine?

A. administration
B. admission
C. administer
D. admit

41. Choose the word that matches the following definition “to be at an average
level”

A. WNL
B. XR
C. HTN
D. Rx

42. ____ (s) are drops of liquid administered to the eye.

A. mEq
B. gtt
C. tsp
D. mcg

43. The asthmatic patient complained of _____

A. HTN

84
B. HR
C. WNL
D. SOB

44. The patient with high blood pressure was diagnosed with _____.

A. WNL
B. Rx
C. SOB
D. HTN

45. If a medicine is ____, it is injected into the fatty layer under the skin with a
syringe.

A. SL
B. P.O.
C. IV
D. SQ

46. Choose the word that matches the following definition “to describe
uncomfortable symptoms”

A. o/e
B. c/o
C. XR
D. WNL

47. Please put 2 _____ (s) of cleaning solution in each ear. Use a dropper.

A. Tbsp
B. drop
C. mcg
D. tsp

48. Choose the word that matches the following definition “the amount of
internal body heat measured”

A. Dx
B. c/o
C. T
D. Rx

85
49. ____ is the specific drug or course of action prescribed to treat a patient’s
medical condition.

A. Rx
B. HTN
C. WNL
D. XR

50. A____ is a measure of volume equal to the amount a standard tablespoon


can hold or about three teaspoons.

A. mcg
B. tbsp
C. gtt
D. tsp

51. Choose the word that matches the following definition “injected into the
fatty layer under the skin with a syringe”

A. subcutaneous
B. intravenous
C. topical
D. sublingual

52. A____ is a unit of liquid volume equal to the amount of liquid which comes
from a dropper, or about 1/12th of a milliliter.

A. mcg
B. tsp
C. gtt
D. mEq

53. If a medicine í taken ____, it is given beneath the tongue

A. SQ
B. SL
C. P.R.
D. IV

54. Choose the word that matches the following definition “1/1000 th the weight
of the minor component of a chemical solution dissolved in the major
component”

86
A. g
B. mcg
C. mEq
D. mg

55. ____ is a condition in which a patient finds it more difficult to breathe than
usual.

A. HR
B. WNL
C. SOB
D. HTN

56. Choose the word that matches the following definition “given beneath the
tongue”

A. sublingual
B. intravenous
C. topical
D. subcutaneous

57. Choose the word that matches the following definition “a measure of
volume equal to the amount a standard teaspoon can hold”

A. gtt
B. Tbsp
C. tsp
D. mcg

58. Choose the word that matches the following definition “taken orally, or
through the mouth”

A. SL
B. SQ
C. P.O.
D. P.R.

59. If a medicine is ____, it is applied to a certain part of the surface of the


body.

A. subcutaneous
B. P.R.

87
C. IV
D. topical

60. A ____ is a measure of volume equal to the amount a standard teaspoon can
hold, or almost five milliliters.

A. Tbsp
B. tsp
C. mcg
D. gtt

61. Choose the word that matches the following definition “injection into a vein
using a syringe, often over a long period of time”

A. IM

B. SQ

C. P.O.

D. IV

62. A ____ is a unit of mass equal to one millionth of a gram.

A. mg
B. mcg
C. ml
D. mEq

63. The patient was complaining of _____

a. Rx
b. SOB
c. HR
d. XR

Session 2

1. QH means:
A. given three times per day
B. given every other day
C. given twice per day

88
D. given every hour
2. If something is ____, it is happening at the present time.
A. pre-existing
B. current
C. new
D. old
3. Choose the word or phrase that matches the following definition: “an
illness that causes discomfort in the head and body”
A. fever
B. cold
C. wheeze
D. throb
4. Fatigue is a ____ of the flu.
A. symptom
B. history
C. allergy
D. procadure
5. Choose the word or phrase that matches the following definition: “the
first instance of something”
A. complaint
B. procedure
C. onset
D. allergy
6. The patient’s _____ included her previous surgeries.
A. social history
B. history of
C. current medical history
D. past medical history
7. A(n) _____ is a patient’s record of lifestyle and personal details, such as
occupation and marital status.
A. family medical history
B. history of
C. past medical history
D. social history
8. If a medication is given ____, it is given three times per day.
A. TID
B. PRN

89
C. QID
D. QOD
9. A _____ is a feeling or physical change that indicates illness.
A. onset
B. procadure
C. allergy
D. symptom
10. A _____ is an illness that can cause coughing, a runny nose, and a sore
throat.
A. cold
B. wheeze
C. throb
D. fever
11. If a medication is given ____, it is given after meals.
A. ac
B. pc
C. qh
D. qhs
12. If a medication is given ____, it is given immediately.
A. ac
B. pc
C. stat
D. qhs
13. According to the thermometer, the patient has a ____
a. fever
b. cough
c. wheeze
d. throb
14. If something is ____, it has liquid flowing or leaking out of it.
a. runny
b. cold
c. hot
d. dry
15. The pain in my back ____ (verb)
a. runny
b. throbs
c. coughs

90
d. wheezes
16. TID means:
a. given as needed
b. given every other day
c. given twice per day
d. given three times per day
17. To ____ is to force air loudly through the throat because of an illness or
throat irritation.
a. runny
b. throb
c. wheeze
d. cough
18. Choose the word or phrase that matches the following definition: “a pain
or illness reported by a patient”
a. data
b. onset
c. procedure
d. complaint
19. If a medication is given ____, it is before meals.
a. qh
b. ac
c. stat
d. pc
20. _____ is a viral illness that can cause fevers, aches, and wheezing,
a. fever
b. headache
c. flu
d. wheeze
21. The patient should take this medication before he eats. The underlined
part has the same meaning as:
a. qh
b. ac
c. pc
d. stat
22. To ____ is to have pain that comes and goes very quickly.
a. wheeze
b. cough

91
c. throb
d. runny
23. Choose the word or phrase that matches the following definition: “a
medical treatment”
a. allergy
b. complaint
c. procedure
d. onset
24. A(n) ____ is pain or illness reported by a patient.
a. onset
b. procedure
c. data
d. complaint
25. If a medication is given ____, it is given every hour,
a. pc
b. ac
c. ahs
d. qh
26. QID means:
a. given every hour
b. given every other day
c. given three times per day
d. given four times per day
27. If a medication is given _____, it is given twice per day.
a. QID
b. TID
c. PRN
d. BID
28. You should take this antibiotic when you go to bed. The underlined part
has the same meaning as:
a. pc
b. ac
c. qhs
d. qh
29. PRN means:
a. given every hour
b. given as needed

92
c. given three times per day
d. given four times per day
30. The patient’s ____ condition was caused by a recent injury
a. current
b. past
c. pre-existing
d. old
31. A ____ is an illness that causes body temperature to rise.
a. wheeze
b. throb
c. cold
d. fever
32. If a medication is given _____, it is given four times per day.
a. QID
b. PRN
c. TID
d. QOD
33. To _____ is to breathe with difficulty in a noisy manner.
a. cough
b. runny
c. throb
d. wheeze
34. A(n) ______ is a medical treatment performed by a doctor or surgeon.
a. procedure
b. complaint
c. allergy
d. onset
35. I need 50 cc’s of lidocaine immediately!. The underlined part has the
same meaning as:
a. qhs
b. stat
c. pc
d. ac
36. If a medication is given ____, it is given every other day.
a. PRN
b. TID
c. QID

93
d. QOD
37. The patient’s _____ included her occupation.
a. past symptom history
b. history of
c. family medical history
d. social history
38. Choose the word or phrase that matches the following definition: “a
record of a patient’s family’s conditions”
a. past symptom history
b. past medical history
c. family medical history
d. social history
39. Medical professionals take medical histories to ____ information that
might help with diagnoses.
a. complaint
b. cover
c. uncover
d. procedure
40. Choose the word or phrase that matches the following definition: “to
breathe noisily and with difficulty”
a. cough
b. wheeze
c. runny
d. throb
41. If a medication is given ____, it is given at bedtime.
a. qh
b. qhs
c. pc
d. ac
42. _____ is a collection of information.
a. data
b. dosage
c. dose
d. dosage form
43. If a medication is given _____, it is given as needed.
a. PRN
b. BID

94
c. QID
d. QOD
44. Choose the word or phrase that matches the following definition: “a
collection of information”
a. data
b. dose
c. dosage
d. dosage form
45. Paul’s family has a ____ cancer.
a. social history
b. past medical history
c. history of
d. family medical history
46. A(n) ____ is a record of the medical conditions of a patient’s family that
might affect the patient’s health.
a. social history
b. past medical history
c. history of
d. family medical history

47. If someone has a _____ something, he or she has experienced it regularly


or repeatedly.
a. history of
b. social history
c. past medical history
d. family medical history
48. QOD means:
a. given as needed
b. given twice per day
c. given four per day
d. given every other day
49. Take two of these after you eat. The underlined part has the same
meaning as:
a. pc
b. ac
c. qhs
d. qh

95
50. Helen was coughing because of the _____
a. headache
b. wheeze
c. flu
d. fever
51. BID means:
a. given four times per day
b. given every hour
c. given as needed
d. given twice per day
52. Choose the word or phrase that matches the following definition:
“having liquid leaking from something”
a. cold
b. runny
c. dry
d. hot
53. A(n) ______ is a medical condition that causes a reaction or illness when
someone comes in contact with a particular substance.
a. complaint
b. procedure
c. onset
d. allergy
54. Choose the word or phrase that matches the following definition: “to
force air loudly through the throat”
a. runny
b. wheeze
c. cough
d. throb
55. A(n) ____is a patient’s record of previous illness, procedures, and other
medical details.
a. history of
b. social history
c. past medical history
d. family medical history
56. A(n) _____ is the start or first instance of something.
a. allergy
b. procedure

96
c. onset
d. complaint
57. You will need to take a pill once every hour until you start to feel better.
The underlined part has the same meaning as:
a. pc
b. ac
c. qhs
d. qh

Session 3

1. A(n) _____ is a measure of heartbeats in a given period of time. One way


to take this measurement is to place the fingers over a major artery in the
neck, wrist, or other location and press them against a bone to feel the
palpations of the heart as blood moves through the artery.
a. percussion
b. pulse
c. pressure
d. pass
2. _____ is the examination of something by touch.
a. inspection
b. palpation
c. percussion
d. auscultation
3. A(n) ____ is a test that examines a urine sample.
a. urinalysis
b. GFR test
c. BUN test
d. CKD test
4. Choose the word or phrase that matches the following definition: “a
waste product found in blood that the kidney usually removes”
a. CKD
b. creatinine
c. BUN
d. albumin

97
5. Get a(n) ____ of that patient’s heart activity.
a. urinalysis
b. endoscope
c. ECG
d. albumin
6. Which of the following is NOT an aspect of checking vital signs?
a. evaluating posture
b. taking temperatune
c. auscultation
d. checking pulse
7. A ____ (BUN) test is a test to determine the amount of urea nitrogen in
the blood.
a. body urea network
b. blood urea nitrogen
c. body urea nitrogen
d. blood urine nitrogen
8. If something is _____, it is related to the kidneys.
a. mental
b. dental
c. rental
d. renal
9. Choose the word that is similar in meaning to the underlined part.<br />
The nurse forgot to determine the quality of the patient’s posture.
a. affect
b. evaluation
c. effect
d. avaluate
10. _____ is a type of protein found in the body.
a. albumin
b. urinalysis
c. renal
d. creainine
11. A(n) ____ is something that someone notices, or the act of noticing
something.
a. palpation
b. inspection
c. observation

98
d. evaluation
12. A(n) _____(ECG) is a measurement of the electrical activity of the heart
over a period of time.
a. electrocardiogram
b. ultrasound
c. magnetic resonance imaging
d. endoscope
13. Choose the word or phrase that matches the following definition: “a
medical imaging technique that use the reflection of sound waves to
produce an image of the body”
a. MRI
b. ultrasound
c. endoscope
d. CT scan
14. Choose the word or phrase that matches the following definition: “a type
of protein found in the body”
a. albumin
b. urinalysis
c. creatinine
d. renal
15. To _____ something is to determine the qualities of its condition or state.
a. evaluate
b. access
c. accept
d. evaluation

16. Which of the following is an aspect of checking vital signs?


a. evaluating patient’s mood
b. evaluating posture
c. auscussion
d. observation of the patient’s body language
17. Choose the word that is similar in meaning to the underlined part.<br />
The doctor performed an investigation of the patient’s ear.
a. auscultation
b. inspection
c. percussion
d. palpation

99
18. A(n) _____ is a form of medical imaging that uses many two-
dimensional X-rays to create a three-dimensional image of an object.
a. endoscope
b. electrocardiogram
c. CT scan
d. ultrasound
19. People can have a relatively normal life with just one _____.
a. albumin
b. creatinine
c. kidney
d. renal
20. Choose the word or phrase that matches the following definition: “a thin,
tubular instrument used to examine the inside of an organ or body cavity”
a. MRI
b. radiography
c. CT scan
d. endoscope
21. A(n) _____ is an organized examination of a patient’s physiological state
as compared to what is understood to be normal.
a. percussion
b. palpation
c. inspection
d. observation
22. Choose the word or phrase that matches the following definition: “a test
that examines a urine sample”
a. urinalysis
b. CKD test
c. GFR test
d. BUN test
23. ____ is the conveyance of information about a person’s physiological or
emotional state by the way he or she moves.
a. body language
b. observation
c. sign language
d. vital signs
24. Which of the following is NOT an advanced medical imaging technique?
a. MRI

100
b. CT scan
c. ECG
d. X-ray
25. The bone is likely broken, but take a(n) ____ to make sure.
a. ECG
b. X-ray
c. GFR
d. radiography
26. The doctor will _____ a tube into the man’s chest to see pictures with the
endoscope.
a. check
b. feed
c. injection
d. gel
27. We will remove some tissue from your liver during the _____.
a. urinalysis
b. GFR test
c. biopsy
d. CKD test
28. Choose the word that is similar in meaning to the underlined part.<br />
The patient’s back pain seemed to make a difference upon her mood.
a. evaluate
b. effective
c. effect
d. affect
29. Which of the following is a physical examination technique?
a. auscultation
b. palpitations
c. vital signs
d. pulse
30. Which of the following is an advanced medical imaging technique?
a. X-ray
b. Rx
c. ECG
d. Dx
31. Apply this ____ to the area before using the ultrasound machine.
a. gel

101
b. ECG
c. feed
d. endoscope
32. To ____ something such as mood is to bring about a change in it.
a. affect
b. effective
c. effect
d. affection
33. Your _____ reading, at 110/65, is on the low end of the normal range.
a. blood pressure
b. glomerular filtration rate
c. albumin
d. creatinine
34. Choose the word or phrase that matches the following definition: “the
use of X-rays to view images of the internal human body”
a. endoscope
b. MRI
c. radiography
d. ultrasound
35. Choose the word or phrase that matches the following definition: “a
medical condition in which a person loses kidney function over time”
a. continual kidney disease
b. chronic kidney diagnosis
c. chronic kidney disease
d. constant kidney disease
36. Which of the following is a physical examination technique?
a. sign language
b. percussion
c. palpitations
d. vital sign
37. _____ is a semi-solid substance placed between the patient’s skin and an
ultrasound probe.
a. lotion
b. cream
c. tablet
d. gel
38. The ____ will show the results from several tests.

102
a. pathology report
b. blood urea nitrogen
c. chronic kidney disease
d. blood pressre
39. A(n) ____ is a thin, tubular instrument used to examine the inside of an
organ or body cavity.
a. endoscope
b. electrocardiogram
c. surgery report
d. ultrasound
40. A(n) ____ is a report that discusses what was found after cells and tissue
were examined.
a. cardiology report
b. pathology report
c. surgery report
d. pharmacy report
41. Choose the word or phrase that matches the following definition: “a test
to determine the amount of urea nitrogen in the blood”
a. CKD test
b. GFR test
c. urinalysis
d. BUN test
42. Which of the following is a physical examination technique?
a. pulse
b. body language
c. palpation
d. vital signs
43.______ are statistical measures of essential body functions such as
temperature, pulse rate, blood pressure, and respiration.
a. vital symptoms
b. vital effects
c. vital signs
d. vital affects
44. Which of the following is an aspect of checking vital signs?
a. evaluating patient’s mood
b. observation of the patient’s body laguage
c. checking pulse

103
d. evaluating posture
45. _____ is the use of x-rays to view images of the internal human body.
a. ultrasound
b. radiography
c. endoscope
d. electrocardiogram
46. Choose the word or phrase that matches the following definition: “a form
of medical imaging that uses many two-dimensional X-rays to create a
three-dimensional image of an object”
a. MRI
b. CT scan
c. radiography
d. ultrasound
47. A(n) ____ (MRI) is a medical imaging technique that uses magnetic
forces on atoms to produce an image of the body.
a. electrocardiogram
b. magnetic resonance imaging
c. electrocardiogram
d. endoscope
48. ____ is a waste product found in blood that the kidney usually removes
a. albumin
b. CKD
c. BUN
d. creatinine
49. Which of the following is an advanced medical imaging technique?
a. Dx
b. X-ray
c. MRI
d. Rx
50. Choose the word that is similar in meaning to the underlined part.<br />
Through watching carefully the doctor noticed that the patient was
limping.
a. palpation
b. observation
c. auscultation
d. percussion
51. A ___ tests how well kidneys are working.

104
a. GFR test
b. BUN test
c. biopsy
d. CKD test
52. Choose the word or phrase that matches the following definition: “a
yellow liquid waste product that the body produces”
a. urethra
b. urine
c. urea
d. urinalysis
53. A (n) ____ is a medical procedure in which a piece of tissue is removed
and examined to help determine an illness.
a. biomedical
b. bioavailability
c. biology
d. biopsy
54. What is one use for percussion techniques?
a. to measure a patient’s pulse
b. to determine the quality of a patient’s breathing
c. to check the condition of internal organs
d. to ecaluate a patient’s mood
55. Choose the word or phrase that matches the following definition: “a
medical imaging technique that uses magnetic forces on atoms produce
an image of the body”
a. ultrasound
b. MRI
c. CT scan
d. radiography
56. ____ is the act of tapping on an area of the body such as the chest or
abdomen to determine the condition of the underlying bone or tissues.
a. evaluation
b. auscultation
c. percussion
d. palpation
57. Who is most likely to be examined by an ultrasound?
a. a patient in surgery
b. a patient with a broken bone

105
c. a patient with avnormal heart activity
d. a patient who is pregnant
58. Which of the following is an aspect of checking vital signs?
a. observation of the patient’s body language
b. taking temperature
c. evaluating posture
d. evaluating patient’s mood
59. A(n) ____ is a medical imaging technique that uses the reflection of
sound waves to produce an image of the body.
a. electrocardiogram
b. endoscope
c. ultrasound
d. radiography
60. A ____ (GFR) test is a test to determine how much kidney function a
person has.
a. glomerular filtration rate
b. glomerular filtration respond
c. glomerular filtration range
d. glomerular filtration route
61. A(n) ____ is a form of radiation that can be used to take pictures of the
internal human body.
a. ultrasound
b. endoscope
c. x-rat
d. electrocardiogram
62. _____ is the examination of something by listening with or without an
instrument such as a stethoscope.
a. observation
b. auscultation
c. percussion
d. palpation
63. If one or both kidneys decline in function you may have _____ failure.
a. rental
b. renal
c. dental
d. mental

106
64. ____ (CKD) is a medical condition in which a person loses kidney
function over time.
a. continual kidney disease
b. chronic kidney diagnosis
c. chronic kidney disease
d. constant kidney disease
65. ____ is a measure of the pressure with which blood moves through the
body.
a. heart pressure
b. pulse pressure
c. blood pressure
d. body pressure

Ss6

1.
__________ stands for Good Clinical Practice.
1. Odour
2. GCP
3. Genotoxic substance
4. GLP
2. All _______ procedures and methods must also be inspected for accuracy.
1. container
2. operation
3. operational
4. Contaminated
3. Contaminated products are no longer pure and acceptable for sale or public use
and, therefore, must be returned to the ______ or destroyed.
1. operation
2. functional
3. maintain
4. manufacturer
4. _______ disposal of toxic waste material was recorded. (= incorrect/ wrong)
1. Eye bath

107
2. Overshoes
3. proper
4. improper
5. The reason for interim testing, or __________, is to check the quality of
pharmaceutical products.
1. Quality assurance
2. Product sampling
3. manufacturing
4. interim testing
6. Protective glasses/_____ must be worn at all times in the laboratory.
1. goggles
2. observe
3. covered
4. to enable
7. Although there were no serious instances of non-compliance, a number of
incidents of undesirable conditions and practices were observed. These need to
be corrected before the _______ review in 30 days
1. Procedure
2. Checklist
3. follow-up
4. to enable
8. Proper protective clothing and safety ______ must be worn at all times
1. disinfectant
2. protective clothing
3. accuracy
4. equipment
9. Endpoint testing is carried out at the end of every manufacturing process. This
is to ensure that all procedures have been performed in _________with industry
and company standards.
1. operation
2. compliance
3. categorize
4. bacterial
10.______ is important and necessary at every step of the processes, activities, and
operations involved in drug manufacturing.
1. Quality assurance
2. Validation
3. documentation
4. operation
11.A/An __________ inspects and verifies the safety procedures in the lab.
1. container
2. clarify
3. auditor

108
4. hazardous
12.This memo is to_____ you that your department has been scheduled for a
periodic audit of the laboratory safety systems and procedures.
1. force
2. advise
3. assure
4. cause
13.Standard operating procedures (SOPs) are written and used by companies to
make it easier for them to follow GxP. These are a set of written instructions to
_____performance and results
1. maintain
2. Finding
3. container
4. internal
14.CAPA focuses on the systematic investigation of non-conformance events
(errors or deviations), to prevent their occurrence (for preventive action)
or_______ (for corrective action).
1. recurrence
2. complaint
3. Procedure
4. ensure
15.Documentation is important and necessary at every step of the processes,
activities, and operations ______ drug manufacturing.
1. up-to-date
2. involved in
3. Endpoint testing
4. Validation
16.I suggest you _____ of toxic waste in the bins provided for this purpose.
1. auditor
2. observe
3. goggles
4. dispose
17.Please ______ receipt of this memo and send us a copy of all your
correspondence with regard to this scheduled audit.
1. confirm
2. to enable
3. claim
4. adhere
18.According to reports, it seems that an unanticipated reaction between the drug's
active ingredient and the chemicals used as part of the cleaning processes at the
site was the ______ of the contamination.
1. force
2. assure

109
3. cause
4. bacterial
19.At the end of every stage of a product's manufacturing process, __________ is
done to maintain quality standards.
1. involved in
2. Product sampling
3. Endpoint testing
4. disinfectant
20.Endpoint testing is carried out at the end of every manufacturing process to
_____ that all procedures have been performed in compliance with industry and
company standards.
1. annual
2. in compliance with
3. ensure
4. compliance
21.Any observation or finding noted by the auditors is _______(d) as either major,
minor, or critical.
1. compliance
2. Finding
3. categorize
4. Validation
22.__________ involves interim and product sampling procedures, which are
carried out to check product quality.
1. biological agent
2. Quality control
3. Safety procedures
4. Quality assurance
23.If any __________ is observed during the audit, the department will be
informed so they can take corrective action.
1. compliance
2. biological agent
3. Gas mask
4. non-compliance
24.A product recall took place following reports from patients that their medication
had a strange odour. Several patients from a number of different countries made
the _______ within a short period of time.
1. complaint
2. deviation
3. to enable
4. compliance
25.Corrective Action/Preventive Action (CAPA) is a part of the overall Quality
Management System (QMS) required for GMP. It ____(es) on the systematic

110
investigation of non-conformance events (errors or deviations), to prevent their
occurrence (for preventive action) or recurrence (for corrective action).
1. process
2. focus
3. force
4. assure
26.Even a product that has been marketed for years might have to be taken off the
market in a __________ if serious adverse reactions occur.
1. Product recall
2. manufacturer
3. Endpoint testing
4. internal
27.__________ stands for Good Documentation Practice
1. GMP
2. CAPA
3. GAP
4. GDP
28.______ documentation not only enables traceability, but also allows a complete
product recall from the market, if necessary.
1. proper
2. to enable
3. beyond
4. Overshoes
29.To ensure that laboratory workers are asked certain questions about safety
procedures, auditors use a __________.
1. receipt
2. Checklist
3. process
4. Overshoes
30.Corrective _____ / Preventive ______ ( CAPA ) is a part of the overall Quality
Management System ( QMS) required for GMP .
1. action
2. functional
3. adhere
4. deviation
31.Aspirin mainly used for ______ and fever.
1. inspection
2. pain relief
3. accordance with
4. disinfectant
32._________ are a set of written instructions to maintain performance and results.
They are the basis of good QA and QC system.
1. Standard operating procedures (SOPs)

111
2. Safety procedures
3. Quality control
4. Genotoxic substance
33.Proper ______ and safety equipment must be worn at all times.
1. Holistic approach
2. non-compliance
3. biological agent
4. protective clothing
34.A few years ago, a well-known European pharmaceutical company was forced
to recall one of its drugs due to _____s of product contamination.
1. Audit
2. claim
3. advise
4. CAPA
35.Validation of cleaning processes is essential in this industry, because chemical
or _______ contamination of drug products can potentially lead to severe public
health risks.
1. bacterial
2. operation
3. recurrence
4. deviation
36.A(n)_____ audit of safety procedures in all laboratories is carried out yearly.
1. annual
2. accuracy
3. auditor
4. Gas mask
37.__________ prevents recurrence of errors
1. advance notice
2. Genotoxic substance
3. Contaminated
4. Corrective action
38.Standard operating procedures (SOPs) are written and used by companies to
make it easier for them to follow GxP These are a set of written instructions to
maintain ______ and results
1. performance
2. complaint
3. up-to-date
4. recurrence
39.Disinfectant must be used on all equipment following an _______ with
laboratory animals.
1. functional
2. categorize
3. equipment

112
4. experiment
40.Even a product that has been marketed for years might have to be taken off the
market if serious _________(s) occur.
1. involved in
2. adverse drug reaction
3. interim testing
4. Endpoint testing
41.Special containers are provided for the _______ of toxic waste materials.
1. disinfectant
2. disposal
3. equipment
4. operational
42.An _____ audit involes inspection and validation of operational methods,
procedures, equipment to ensure functionality, accruacy and validity
1. clarify
2. Gas mask
3. internal
4. functional
43.Any observation or _______ noted by the auditors is categorized as either
major, minor, or critical.
1. accuracy
2. categorize
3. Finding
4. functional
44.Beyond the filed of manufacturing, good practice must be ______(ed) to in all
processes in a pharmaceutical company
1. advise
2. action
3. adhere
4. proper
45.The goal of an internal audit is to identify any areas requiring corrective or
preventive actions. It is done to ______ compliance with industry standards,
especially for safety procedures.
1. assure
2. maintain
3. action
4. advise
46.The quality assurance ______ in good manufacturing practice (GMP) includes
product quality control, sampling, and testing.
1. receipt
2. process
3. Good Manufacturing Practice
4. Procedure

113
47.It is absolutely essential to move lab mice outdoors in closed ____(s) .
1. clarify
2. cage
3. cause
4. dispose
48.Special ______(s) are provided for the disposal of toxic waste materials.
1. disinfect
2. equipment
3. biological agent
4. container
49.Preventive action prevents ______ of errors.
1. advance notice
2. occurrence
3. goggles
4. compliance
50.Manufacturing processes and procedures must go through periodic __________
to guarantee that they are still of an acceptable standard.
1. categorize
2. functional
3. Validation
4. documentation
51.______ must be used on all equipment following any experiments with
laboratory animals.
1. disinfectant
2. Quality control
3. inspection
4. disinfect
52.Inspection and validation are required to prove that the manufacturing and
testing equipment is ______.
1. functional
2. operational
3. internal
4. experiment
53.An __________ is a distinctive unpleasant smell.
1. auditor
2. GLP
3. GMP
4. Odour
54.All operational methods and procedures must also be inspected for ______.
1. accuracy
2. annual
3. categorize
4. disposal

114
55.A well-known European pharmaceutical company was ____(ed) to recall one of
its drugs due to claims of product contamination.
1. Audit
2. claim
3. force
4. pure
56.__________ stands for Good Auditing Practice.
1. Eye bath
2. GCP
3. GAP
4. annual
57.Proper documentation not only _____(s) traceability, but also allows a complete
product recall from the market.
1. internal
2. functional
3. equipment
4. to enable
58.A/an __________ is a safety device consists of a sheet of a fire retardant
material which is placed over a fire in order to extinguish it.
1. Gas mask
2. performance
3. Fire blanket
4. non-compliance
59.The reason for ________, or product sampling, is to check the quality of
pharmaceutical products
1. disinfectant
2. Genotoxic substance
3. Product recall
4. interim testing
60.The documentation required for all research processes and development steps
ensures the __________ of a drug.
1. manufacturing
2. Traceability
3. Checklist
4. interim testing
61.Auditors generally watch or _______safety procedures in the lab.
1. adhere
2. improper
3. observe
4. disposal
62.Lab animals must be transported in _____ cages.
1. occurrence
2. clarify

115
3. container
4. covered
63.Endpoint testing is carried out at the end of every manufacturing process. This
is to ensure that all procedures have been performed ______ industry and
company standards.
1. in compliance with
2. Product recall
3. non-compliance
4. complaint
64.All laboratory work must be documented in ________ GLP.
1. bio-safety cabinet
2. interim testing
3. accordance with
4. Product sampling
65.__________ prevents occurrence of errors.
1. Overshoes
2. Preventive action
3. Safety procedures
4. Eye bath
66.__________ involves all manufacturing processes in GMP which make sure the
goods produced are kept at high standards.
1. Genotoxic substance
2. Quality control
3. Quality assurance
4. Safety procedures
67.__________ stands for Good Laboratory Practice.
1. GCP
2. GMP
3. Preventive action
4. GLP
68.__________ stands for Corrective Action/Preventive Action. It is a part of the
overall Quality Management System (QMS) required for GMP
1. GAP
2. Quality assurance
3. CAPA
4. proper
69.All work with virus- infected animals must be performed in the _______.
1. biological agent
2. operational
3. accuracy
4. bio-safety cabinet
70.Small biological agent spills must be covered with a paper towel and treated
with ________ .

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1. clarify
2. accuracy
3. bleach
4. receipt
71.__________ stands for Good Safety Practice
1. Genotoxic substance
2. advance notice
3. GSP
4. CAPA
72.__________ make sure that the health and well-being of laboratory workers are
guaranteed.
1. Safety procedures
2. Quality control
3. Preventive action
4. disinfectant
73._______ of this meeting was very short.
1. documentation
2. Preventive action
3. advance notice
4. accordance with
74.Small _______ spills must be covered with a paper towel and treated with
bleach .
1. biological agent
2. protective clothing
3. operational
4. Holistic approach
75.A __________ looks at all aspects of a pharmaceutical company together to
make sure that the entire process meets high industry standards.
1. Fire blanket
2. Holistic approach
3. Safety procedures
4. Quality assurance
76.A few years ago, a well-known European pharmaceutical company was forced
to recall one of its drugs due to claims of product contamination. The drug
manufacturer was unable to say just how many patients were taking this drug at
the time. However, it estimated the _____figure at over 40,000 people.
1. force
2. due to
3. global
4. focus
77.A/an __________ is a device that you wear over your face in order to protect
yourself from poisonous gases.
1. action

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2. internal
3. Gas mask
4. non-compliance
78.______ the field of manufacturing, good practice must be adhered to in all
processes in a pharmaceutical company. No process can be considered isolated
from the others.
1. adhere
2. Contaminated
3. Eye bath
4. beyond
79.An internal __________ involves inspection and validation of operational
methods, procedures, equipment to ensure functionality, accuracy and validity.
1. advise
2. action
3. Audit
4. due to
80.__________ stands for Good Manufacturing Practice.
1. GCP
2. GMP
3. GDP
4. GLP
81.The company claims that a cleaning error was the reason for the entire incident.
This clearly underlines the ______ of underestimating the importance of the
cleaning process in pharmaceutical manufacturing.
1. ensure
2. danger
3. adhere
4. cause
82.Toxic or ______ materials must be disposed of properly.
1. pain relief
2. hazardous
3. container
4. Overshoes
83.Scientists often read journals and go to international conferences, because they
need to stay _________ in their scientific fields.
1. up-to-date
2. involved in
3. contamination
4. performance
84.You need to ______ all equipment following any experiments with laboratory
animals.
1. disinfect
2. equipment

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3. Fire blanket
4. Endpoint testing
85.Contaminated products are no longer _______ and acceptable for sale or public
use and, therefore, must be returned to the manufacturer, or destroyed.
1. ensure
2. manufacturer
3. pure
4. cage
86.A few years ago, a well-known European pharmaceutical company was forced
to recall one of its drugs due to claims of product _____.
1. documentation
2. Validation
3. manufacturing
4. contamination
87.__________ drugs are no longer pure and acceptable for sale or public use and,
therefore, must be returned to the manufacturer, or destroyed.
1. Quality assurance
2. Overshoes
3. Contaminated
4. Quality control
88.______ and validation are required to prove that the manufacturing and testing
equipment is functional
1. functional
2. internal
3. Overshoes
4. inspection
89.Please confirm _____ of this memo and send us a copy of all your
correspondence with regard to this scheduled audit.
1. receipt
2. process
3. Checklist
4. operation
90.Documentation is important and necessary at every step of the processes,
activities, and ______(s) involved in drug manufacturing.
1. contamination
2. functional
3. operation
4. Checklist
91.We should tell the lab staff to _____ that all the labs are spotlessly clean and
that all lab devices and equipment are where they should be - at every single
workstation.
1. performance
2. compliance

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3. documentation
4. double-check
92.__________ (QMS) is a formalized system that documents processes,
procedures, and responsibilities for achieving quality policies and objectives.
1. Quality Management System
2. Holistic approach
3. Preventive action
4. Contaminated
93.A well-known European pharmaceutical company was forced to recall one of its
drugs ________ claims of product contamination.
1. process
2. due to
3. Audit
4. documentation
94.Corrective Action/Preventive Action (CAPA) focuses on the systematic
investigation of non-conformance events (errors or _______(s)), to prevent their
occurrence (for preventive action) or recurrence (for corrective action).
1. Procedure
2. occurrence
3. Validation
4. deviation
95.__________ are shoe covers used to reduce foot borne contamination and help
maintain a sterile environment.
1. Overshoes
2. Eye bath
3. Gas mask
4. Contaminated
96.___________ is a/an apparatus to wash the eyes after exposure to chemical
contamination.
1. Eye bath
2. Quality control
3. Gas mask
4. inspection
97.The quality assurance process in good ______ practice (GMP) includes product
quality control, sampling, and testing.
1. functional
2. manufacturing
3. process
4. disinfectant
98.Endpoint testing is carried out at the end of every manufacturing process. This
is to ensure that all _______(s) have been performed in compliance with
industry and company standards.
1. bacterial

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2. complaint
3. performance
4. Procedure
99.To ______ something means to make it easier to understand, usually by
explaining it in more detail.
1. clarify
2. internal
3. Finding
4. Checklist
100. __________ is a chemical that damages cellular DNA, resulting in
mutations or cancer.
1. Contaminated
2. Genotoxic substance
3. Eye bath
4. Corrective action

1. ______ is a material used to wrap or protect good that are sold in stores

1. medication
2. Self-medicate
3. Prescription
4. packaging
2. In Russia, we prefer to buy over-the-counter products, like cold remedies
or ______ syrup, from people in pharmacies wearing white lab coats
1. memo
2. cure
3. accurate
4. cough
3. By the end of the meeting I hope we will have come up with _______ for
getting the project off the ground and a full to do list.
1. licence
2. deliverables
3. expertise

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4. meet requirements
4. __________ operates complex scientific instruments and performs tests
to determine whether ingredients in liquids, powders, or tablets meet
requirements.
1. Clinical research associate
2. Laboratory technician
3. Research and Development (R&D)
4. Regulatory Affairs
5. In Russia, we prefer to buy over-the-counter products, like cold _____ or
cough syrup, from people in pharmacies wearing white lab coats.
1. cough syrup
2. licence
3. determine
4. remedy
6. __________ is the information about a medication that is assessed before
clinical trials.
1. Clinical research associate
2. Preclinical data
3. Feasibility study
4. Clinical Affairs
7. With your input, I'll be able to finalize the timelines for planning and
implementation and decide on ______(s) before our next meeting.
1. finalize
2. determine
3. promotion
4. milestone
8. __________drug is the medicine bought in a pharmacy and requiring a
written note from the doctor.
1. Preclinical data

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2. Prescription
3. Self-medicate
4. compound
9. Feasibility study is an ______ to determine the advantages, practicality,
and profitability of a proposed project
1. practicality
2. investigation
3. expertise
4. drug authority
10. With your input, I'll be able to _____ the timelines for planning and
implementation and decide on milestones before our next meeting.
1. deadline
2. pipeline
3. finalize
4. Liaise
11. I operate complex scientific instruments and perform tests to determine
whether ingredients in liquids, powders, or tablets ______.
1. marketing claim
2. meet requirements
3. encouraging
4. drug authority
12. Feasibility study is an investigation to _____ the advantages, practicality,
and profitability of a proposed project.
1. effective
2. determine
3. expertise
4. licence

123
13. It's the __________ job to research, write, and edit clinical and study
reports before the pharmaceutical company submits them to regulatory
authorities.
1. consultant
2. Medical writer
3. meet requirements
4. Clinical Affairs
14. In Europe, the strength of medicine varies ______ depending on what
health authorities allow.
1. drug authority
2. encouraging
3. cost estimate
4. considerably
15. I collect drug safety information about patients on our _______(s).
1. medication
2. Production
3. packaging
4. Prescription
16. I am the clinical trial manager ______ this project and am supported by
two clinical research associates who will work with test centres in northern Italy
and in Slovenia
1. cheerful
2. deliverables
3. practicality
4. assigned to
17. When people __________ with another, they work together and keep
each other informed about what is happening.
1. degree
2. finalize

124
3. Liaise
4. conclusion
18. Unlike in many countries, you'll also find many ______, bright coloured
ads in magazines, which promote anti-depressants and other prescription drugs
in the US.
1. cough syrup
2. licence
3. cheerful
4. imperfection
19. __________ means to take medicine without consulting a physician.
1. Prescription
2. Analgesic
3. Self-medicate
4. Cross-cultural
20. Charley is to describe the technical equipment needed with a ________
by the end of the month.
1. cost estimate
2. cross-functional
3. health authority
4. investigation
21. __________ department compiles the drug documentation and submits it
to the drug regulatory authorities so the company can get authorization to
market the product.
1. Preclinical data
2. Quality Assurance (QA)
3. Production
4. Regulatory Affairs
22. __________ is someone you work with; a co-worker
1. Analgesic

125
2. Cross-cultural
3. packaging
4. Colleague
23. _____ a dry substance in the form of very small grains.
1. deadline
2. develop
3. Ingredient
4. powder
24. In France, medicines should not only ______ a disease, but also look
fresh and interesting.
1. cough
2. considerably
3. remedy
4. cure
25. A __________ develops pharmaceutical dosage forms.
1. Formulation scientist
2. Pharmacovigilance manager
3. Health regulations
4. consultant
26. _______ is someone whose job is to give advice on a particular subject.
1. consultant
2. Medical writer
3. Formulation scientist
4. clinical research organization (CRO)
27. A __________ is a company which is part of a larger and more important
company.
1. Subsidiary
2. Cross-cultural

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3. Project manager
4. Analgesic
28. __________ department finds new substances to make new drug
formulations or changes existing dosage forms, for example, from tablets to
capsules.
1. clinical trial manager
2. Production
3. Research and Development (R&D)
4. Regulatory Affairs
29. I _____ complex scientific instruments and perform tests to determine
whether ingredients in liquids, powders, or tablets meet requirements.
1. operate
2. licence
3. cheerful
4. degree
30. Feasibility study is an investigation to determine the advantages,
_______, and profitability of a proposed project.
1. practicality
2. investigation
3. Feasibility study
4. analytical testing
31. Since the conclusion of our successful feasibility study, we have also
obtained very _____ preclinical data.
1. encouraging
2. conclusion
3. practicality
4. deliverables
32. Project members from Marketing, Production, and Clinical Affairs are
already ______

127
1. on board
2. compound
3. accurate
4. Subsidiary
33. I would like you to introduce yourselves and say something about your
professional background, area of _______.
1. expertise
2. deliverables
3. determine
4. licence
34. __________ is a medication to reduce or eliminate pain.
1. Subsidiary
2. Analgesic
3. packaging
4. Colleague
35. __________ stands for bachelor's degree.
1. B.S.
2. oily
3. Ingredient
4. memo
36. __________is a substance in a drug.
1. Prescription
2. Ingredient
3. Project manager
4. Packaging technician
37. We plan to ______ our new drug in Europe first and to apply for Food
and Drug Administration (FDA) approval in the US the following year.
1. conclusion

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2. launch
3. clinical research organization (CRO)
4. production line
38. CRO is searching for omeone to co-ordinate and perform _______ for
stability studies of new products.
1. Clinical research associate
2. conceptual design
3. analytical testing
4. practicality
39. We will need to fill the position of clinical trial manager shortly. I'd
appreciate it if you could write up a job _______ with the input below and place
it in the pharmaceutical journal we normally use.
1. advertisement
2. marketing claim
3. imperfection
4. investigation
40. Pharmaceutical companies must report serious adverse events to the
______.
1. Health regulations
2. medication
3. cost estimate
4. health authority
41. Pharmaceutical products in the__________ are future drugs, not yet on
the market.
1. health authority
2. pipeline
3. accurate
4. milestone

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42. I was involved in the initial ______ phase, the planning and building of
our new pharmaceutical facility in Shanghai, and now I am the plant manager.
1. analytical testing
2. Marketing and Sales
3. marketing claim
4. conceptual design
43. We test or organize testing on live subjects and make sure that our drugs
are safe and ______ for the patients.
1. encouraging
2. expertise
3. effective
4. licence
44. __________ means involving two or more different cultures.
1. Subsidiary
2. Cross-cultural
3. Colleague
4. Analgesic
45. __________ department plans the promotion and distribution of drugs
which will be launched, and makes decisions about the packaging or tablet
colour of new products.
1. Quality Assurance (QA)
2. Packaging technician
3. Regulatory Affairs
4. Marketing and Sales
46. __________ performs clinical trials. __________ must also summarize,
interpret and process clinical data.
1. Packaging technician
2. Self-medicate
3. Clinical research associate

130
4. Laboratory technician
47. __________ stands for master of science degree.
1. MSc
2. B.S.
3. Cross-cultural
4. memo
48. We plan to launch all of these products in Europe first and to ______
food and drug administration (FDA) approval in the US the following year.
1. apply for
2. Formulation scientist
3. effective
4. accurate
49. _______ is an organization that provides support to the pharmaceutical,
biotechnology, and medical device industries in the form of research services
outsourced on a contract basis.
1. Clinical research associate
2. clinical research organization (CRO)
3. clinical trial manager
4. apply for
50. Formulation scientists _____ pharmaceutical dosage forms.
1. deadline
2. licence
3. pharmaceutical
4. develop
51. According to European law, a qualified person is responsible for the
quality of each product that leaves the ______.
1. apply for
2. production line
3. Medical writer

131
4. profitability
52. __________ department compounds the raw materials into drugs,
packages them, and puts in the leaflets for the patients.
1. Production
2. Regulatory Affairs
3. Project manager
4. Prescription
53. Pharmaceutical companies must report serious ______events to the health
authorities.
1. health authority
2. adverse
3. accurate
4. pipeline
54. You need to be able to write scientifically and technically _____
protocols in English.
1. accurate
2. conclusion
3. adverse
4. Liaise
55. A project manager co-ordinates and manages the ______ teams that
develop and launch a new product.
1. Prescription
2. Cross-cultural
3. Production
4. cross-functional
56. As far as Marketing is concerned, Carole Marks will be flying in from
France. She'll give us more information on the ______(s) and a target patient
profile.
1. Packaging technician

132
2. anti-depressant
3. marketing claim
4. Marketing and Sales
57. __________ is an investigation to determine the advantages, practicality,
and profitability of a proposed project.
1. Feasibility study
2. Preclinical data
3. Prescription
4. Regulatory Affairs
58. A(n) ______ is a short official note that is sent by one person to another
within the same company or organization.
1. remedy
2. MSc
3. memo
4. Ointment
59. Unlike in many countries , you'll also find many cheerful, bright coloured
ads in magazines, which promote ______ and other prescription drugs in the
US.
1. marketing claim
2. meet requirements
3. advertisement
4. anti-depressant
60. The marketing department plans the _____ and distribution of drugs
which will be launched, and make decisions about the packaging or tablet
colour of new products
1. promotion
2. effective
3. conclusion
4. finalize

133
61. Quality is important all over the world, but in Japan we take it one step
further. We will reject a whole shipment of drugs if we find the smallest scratch
or ______ in one single package, even if it makes no difference to the product at
all.
1. effective
2. assigned to
3. imperfection
4. Prescription
62. __________ stands for bachelor of science degree.
1. MSc
2. MS
3. BSc
4. Cross-cultural
63. A __________ collects drug safety information after approval and reports
any serious adverse events to the health authorities.
1. Pharmacovigilance manager
2. Marketing and Sales
3. clinical trial manager
4. Packaging technician
64. Some companies are successful at marketing their drugs all over the
world without making any major changes to them. Others have different
formulations, advertising, and packaging in each country, due to differences in
______(s) and laws.
1. market
2. custom
3. operate
4. milestone
65. Feasibility study is an investigation to determine the advantages,
practicality, and _____ of a proposed project.
1. determine

134
2. profitability
3. drug authority
4. practicality
66. __________ department tests or organizes testing on live subjects, and
makes sure that the drugs are safe and effective for the patients.
1. Research and Development (R&D)
2. Clinical Affairs
3. Feasibility study
4. Quality Assurance (QA)
67. Formulation scientists develop ______ dosage forms.
1. practicality
2. Preclinical data
3. pharmaceutical
4. Cross-cultural
68. I did research on clinical ________.
1. Subsidiary
2. Ingredient
3. methodology
4. Health regulations
69. ________a date or time by which you have to do or complete something.
1. deadline
2. Production
3. Colleague
4. Ingredient
70. __________ stands for master's degree.
1. Feasibility study
2. Colleague
3. Clinical research associate

135
4. MS
71. A __________ co-ordinates and manages the cross-functional teams that
develop and launch a drug.
1. Packaging technician
2. Feasibility study
3. Preclinical data
4. Project manager
72. Since the ______ of our successful feasibility study, we have also
obtained very encouraging preclinical data (= end)
1. conclusion
2. cough syrup
3. milestone
4. encouraging
73. __________ department ensures that products meet the standards which
the law requires, and contain the active ingredients advertised.
1. Clinical research associate
2. Marketing and Sales
3. Quality Assurance (QA)
4. Clinical Affairs
74. A __________ is personally responsible for the quality of each product
that leaves the production line. A __________ must manage all the processes in
production, QA, and the labs to make sure SOPs are followed.
1. production line
2. Qualified person
3. Formulation scientist
4. Medical writer
75. Before they become fully qualified, pharmacists in the US have to take an
examination to get a _____ to practise pharmacy.
1. Liaise

136
2. deliverables
3. milestone
4. licence
76. Regulatory affairs department compiles the drug documentation and
submits it to the drug regulatory authorities so the company can get
authorization to _____the product
1. marketing claim
2. market
3. operate
4. remedy
77. I received my master's ______ at New York University and licence to
practise pharmacy in the United States
1. adverse
2. determine
3. operate
4. degree
78. A _______ is a key position in the management of clinical trials. He is
responsible for managing the clinical trial process by implementing effective
strategies for his/her organization.
1. Cross-cultural
2. Feasibility study
3. Production
4. clinical trial manager
79. __________ are rules or laws about health.
1. Feasibility study
2. Preclinical data
3. Health regulations
4. Analgesic

137
80. We compile the drug documentation and send it to the regulatory
_______ so we can get authorization to market the product.
1. Production
2. compound
3. drug authority
4. advertisement

ss 5
1. Medicine needs to be easily accessible. This is, of course, a question of
public health. On the other hand, these same products can _____ if used
incorrectly. This danger must be avoided.
1. occur
2. do harm
3. harmful
4. discovery
2. Scientists have made a major ______ in the treatment of cancer.
1. Eye drops
2. Oral solution
3. palpitations
4. breakthrough
3. When someone has _______, their heart beats very fast in an irregular
way. (conditions of heart racing.)
1. palpitations
2. composition
3. directions
4. Indigestion
4. __________ is a mixture of ingredients prepared in a certain way and
used for a specific purpose.
1. Nasal spray

138
2. Formulation
3. Oral solution
4. Pneumonia
5. __________ refers to a group of diseases that affect how your body uses
blood sugar (glucose).
1. policy
2. Diabetes
3. Toxicity
4. Ointments
6. The science of poisons, including their source, chemical composition,
action, tests , and even their _____(s) , is what we call Toxicology
1. discovery
2. adequate
3. Pneumonia
4. antidote
7. Medication must meet four criteria in order to obtain the status of a non-
prescription or OTC. It must have: a large ______, low incidence of side effects,
low potential for misue and abuse, and labelling that provides adequate
directions for sale and effective use.
1. Allergic reaction
2. margin of safety
3. pharmacologist
4. involvement
8. When substances are taken with alcohol or antibiotics, their chemical
form could change and even cause ______ side effects.
1. anaemia
2. antidote
3. harmful
4. aerosol

139
9. Solution is a liquid in which another substance has been _____(d)
1. aerosol
2. dissolve
3. Obtainable
4. discovery
10. Research is the process of testing chemical compounds, with the goal of
finding a substance which has a ______ on a targeted disease.
1. beneficial effect
2. incidence
3. occasionally
4. Sublingual tablet
11. __________ is the condition of feeling sick and the feeling that you are
going to vomit.
1. Nausea
2. Research
3. Bronchitis
4. Dose
12. Suppository is a solid medicine which melts slowly in the _______ or
vagina.
1. device
2. rectum
3. Nausea
4. melt
13. __________ are liquid preparations for oral use that are intended to be
administered in small amount with the aid of a suitable measuring device.
1. Oral drops
2. Inhaled
3. Lotions
4. Dosage form

140
14. When you ______ food, you use your teeth to break it up in your mouth
so that it becomes easier to swallow.
1. Pill
2. chew
3. Chronic
4. harmful
15. __________ are fluid preparations (aqueous) for external application
without friction.
1. Eye drops
2. Dosage
3. Lotions
4. Chronic
16. __________ is a scientific study designed to systematically test a medical
intervention in humans.
1. Clinical trial
2. Insomnia
3. Pharmacodynamics
4. Oral drops
17. __________ is a unique, pharmacologically active product that has never
previously been synthesized or used to treat disease.
1. Hard gelatin capsule
2. Pharmacodynamics
3. Behind-the-counter
4. New chemical entity
18. __________ are semi-solid, smooth greasy preparations for application to
the skin for healing.
1. Inhaled
2. Eye drops
3. Ointments

141
4. Diarrhoea
19. If you have __________ , you have pains in your stomach and chest that
are caused by difficulties in digesting food.
1. palpitations
2. Dosage form
3. Indigestion
4. Fever
20. __________ is the amount and frequency of a medicinal drug that may be
taken safely.
1. Dosage form
2. Dosage
3. Tablet
4. Dose
21. One of criteria to obtain the status of OTC product in the US is that a
medication must have low _______ of side effects.
1. abuse
2. incidence
3. Lozenge
4. Bronchitis
22. In the fields of medicine, biotechnology and pharmacology, drug ______
is the process by which new candidate medications are discovered.
1. discovery
2. incidence
3. Diarrhoea
4. involvement
23. ________is a medical condition in which there are too few red cells in
your blood, causing you to feel tired and look pale.
1. Asthma
2. anaemia

142
3. Lozenge
4. Nausea
24. __________ is Phase-1 study in which a test product is administered to
human beings.
1. First in-man study
2. Soft gelatin capsule
3. Sublingual tablet
4. Time-release delivery
25. Some medications are available in _____ form, such drops or syrup.
1. rectum
2. liquid
3. expert
4. Asthma
26. Pharmaceutical product labelling must provide ______ directions for sale
and effective use.
1. device
2. directions
3. adequate
4. antidote
27. __________ is the final form of the medicine, e.g. Tablet, powder, gel,
spray, etc.
1. Diarrhoea
2. Toxicity
3. Dosage form
4. Eye drops
28. __________ is the degree to which a substance (a toxin or poison) can
harm humans or animals.
1. Tablet
2. Toxicity

143
3. Lozenge
4. Lotions
29. __________ is the inflammation of the lungs. The lungs become filled
with liquid which makes it difficult to breathe.
1. Pharmacodynamics
2. Lozenge
3. Pneumonia
4. anaemia
30. __________ is the body's exaggerated immune response to an internal or
surface agent.
1. Over-the-counter
2. Dosage form
3. Nasal spray
4. Allergic reaction
31. __________ is a liquid in which another substance has been dissolved.
1. Toxicologist
2. Oral solution
3. Tablet
4. Nasal spray
32. __________ is the study of poisons.
1. Toxicology
2. Toxicologist
3. Nasal spray
4. Pneumonia
33. __________ is a small, round piece of medicine to be swallowed without
chewing.
1. Syrup
2. Pill
3. Asthma
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4. melt
34. An Inhaler is a small device with medicine to _____ through the mouth.
1. breathe in
2. Dosage form
3. breakthrough
4. Oral solution
35. __________ is a solid medicine which melts slowly in the rectum or
vagina.
1. Dosage form
2. Toxicity
3. Liniment
4. Suppository
36. A specialist or ____ in the scientific field of chemistry is called a chemist.
1. apply
2. Liniment
3. expert
4. Tablet
37. Which of the following dosage form(s) do the patients _____ (= prefer)?
1. Asthma
2. favour
3. rectum
4. Septic
38. Mensamint is a new dosage form of Mensadent. Known side effects often
include loss of sleep if taken in the late afternoon or evening. ______ (now and
then ), an increase in blood pressure may occur.
1. Bioavailability
2. occur
3. occasionally
4. Pharmacology
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39. __________is the amount of substance given at one time.
1. Nausea
2. Asthma
3. Toxicologist
4. Dose
40. Toxicology is the study of _____.
1. Tablet
2. Toxicity
3. poison
4. Topical
41. If a wound or a part of your body becomes __________ , it becomes
infected.
1. liquid
2. expert
3. Septic
4. Chronic
42. __________ is a substance dispensed as a fine spray from a container into
the nostril.
1. Suppository
2. Nasal spray
3. Dosage form
4. Formulation
43. __________ is a type of capsule that is usually used to contain oils and
for active ingredients that are dissolved or suspended in oil.
1. Bioavailability
2. Hard gelatin capsule
3. Soft gelatin capsule
4. Pharmacodynamics

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44. If you have a __________ when you are ill, your body temperature is
higher than usual.
1. Tablet
2. Fever
3. aerosol
4. apply
45. Someone who suffers from __________ finds it difficult to sleep.
1. Clinical trial
2. Pneumonia
3. Insomnia
4. Inpatient
46. __________ is a sweet, liquid medicine taken with a spoon or cup.
1. Asthma
2. Eye drops
3. Oral solution
4. Syrup
47. __________ is the process of testing chemical compounds, with the goal
of finding a substance which has a beneficial effect on a targeted disease.
1. Lozenge
2. Chemist
3. Development
4. Research
48. An __________ is an illness, especially one that is not very serious.
1. Lotions
2. Asthma
3. aerosol
4. Ailment

147
49. __________ is the study of drugs, how they work, and what they do in
the body. __________ can be divided into two separate areas:
Pharmacodynamics and Pharmacokinetics.
1. Development
2. Pharmacology
3. Bioavailability
4. Pharmacokinetics
50. __________ is a lung condition which causes difficulty in breathing.
1. Nasal spray
2. Suppository
3. Diarrhoea
4. Asthma
51. Medication must meet four criteria in order to abtain the status of a non-
prescription or over-the counter (OTC) product. It must have: a large margin of
safety, low incidence of side effects, low potential for ______ and abuse, and -
labelling that provides adequate directions for sale and effective use.
1. abuse
2. favour
3. discovery
4. misuse
52. __________ are a kind of medicine that you put in your eyes one drop at
a time.
1. Lotions
2. Ointments
3. Oral drops
4. Eye drops
53. Suppository is a solid medicine which_____(s) slowly in the rectum or
vagina.
1. Tablet
2. melt

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3. expert
4. Fever
54. __________ is the study of physiological effects of drugs and the
mechanisms of their actions (what the drug does to the body)
1. Diarrhoea
2. Hard gelatin capsule
3. Pharmacology
4. Pharmacodynamics
55. __________ is administered by placing it under the tongue.
1. Chewable tablet
2. Suppository
3. First in-man study
4. Sublingual tablet
56. __________ is a solid preparation that is intended to dissolve or
disintegrate slowly in the mouth (e.g.. Sore throat)
1. Bronchitis
2. Pneumonia
3. Diarrhoea
4. Lozenge
57. __________ is a type of capsule that is usually used to contain medicine
in the form of dry powder or very small pellets.
1. Hard gelatin capsule
2. Route of administration
3. Pharmacodynamics
4. Development
58. __________ is chewed prior to swallowing. It is designed for
administration to children e.g. vitamin products.
1. New chemical entity
2. Chewable tablet

149
3. Nasal spray
4. Hard gelatin capsule
59. __________dosage forms are applied to the skin surface.
1. Pill
2. Topical
3. Liniment
4. Asthma
60. A __________ illness or disability lasts for a very long time. Opposite to
acute.
1. Eye drops
2. Bronchitis
3. Chronic
4. Lozenge
61. Mensamint is a new dosage form of Mensadent. Known side effects often
include loss of sleep if taken in the late afternoon or evening. Occasionally, an
increase in blood pressure may _____.
1. occur
2. occasionally
3. Chemist
4. Patch
62. __________ is a condition in which faeces are discharged from the
bowels frequently and in a liquid form.
1. Diarrhoea
2. Bronchitis
3. Dosage form
4. Lozenge
63. __________ is the proportion of a drug or other substance which enters
the circulation when introduced into the body and so is able to have an active
effect.

150
1. Pharmacodynamics
2. Pharmacology
3. Pharmacokinetics
4. Bioavailability
64. __________ drug is a product which can be sold without the patient
seeing a doctor.
1. Toxicity
2. Over-the-counter
3. Time-release delivery
4. Pharmacodynamics
65. __________is an uncoated tablet containing substances that react in the
presence of water and give off carbon dioxide.
1. Development
2. Effervescent tablet
3. Formulation
4. Pharmacodynamics
66. __________ is a medication on material or cloth placed on the skin.
1. Asthma
2. Oral solution
3. Patch
4. Dosage
67. __________ is an expert in the science of poisons.
1. Toxicologist
2. Bronchitis
3. Oral solution
4. Liniment
68. Drug development is the process of ________ scientific discoveries made
during the research process, with the goal of producing a marketable drug.
1. Pharmacology
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2. Pharmacodynamics
3. carry forward
4. pharmacologist
69. __________ is the process of carrying forward scientific discoveries
made during the research process, with the goal of producing a marketable drug
1. Pharmacokinetics
2. Bioavailability
3. Research
4. Development
70. __________ is an expert in chemistry. In the UK, this word is also used
for the person who prepares and sells medicine, also known as a pharmacist in
the US.
1. Chemist
2. anaemia
3. Research
4. Ailment
71. __________ is the study of the bodily absorption, distribution,
metabolism, and excretion of drugs (what the body does to the drug)
1. Hard gelatin capsule
2. Pharmacokinetics
3. Bioavailability
4. Oral solution
72. __________ is the path by which a drug, fluid, poison, or other substance
is taken into the body.
1. Allergic reaction
2. First in-man study
3. Route of administration
4. Formulation

152
73. __________ is a drug delivery system consisting of a semi-solid, jelly-
like substance.
1. Patch
2. Pill
3. Gel
4. Liniment
74. An inhaler is an aerosol dispensing _____ which releases medication into
the mouth of the patient.
1. rectum
2. device
3. Nausea
4. Fever
75. __________medicine can be purchased without a prescription but only
with the personal involvement of a pharmacist.
1. Bioavailability
2. Allergic reaction
3. Pharmacodynamics
4. Behind-the-counter
76. __________ is a hard, compressed medication in round, oval or square
shape
1. Tablet
2. Syrup
3. Patch
4. Oral solution
77. We will have to test the bioavailability to be able to calculate dosages for
non-intravenous routes of _____ for this NCE.
1. Behind-the-counter
2. Soft gelatin capsule
3. drug administration

153
4. Pharmacodynamics
78. Mensamint is a new dosage form of Mensadent ( _________ with
plysician's prescription only)
1. occasionally
2. breathe in
3. palpitations
4. Obtainable
79. Chemists and ________(s) are also interested in how the medicine is
administered, so they often ask about its formulation.
1. Pharmacodynamics
2. pharmacologist
3. harmful
4. Formulation
80. _______ is a container with a liquid that is administered in spray form.
1. aerosol
2. Tablet
3. anaemia
4. Lotions
81. __________ is the inflammation of the bronchial tubes, characterized by
coughing, difficulty in breathing.
1. Formulation
2. Bronchitis
3. Diarrhoea
4. Suppository
82. Patches are easy to _______, not too expensive, and can be placed right at
the point of pain.
1. abuse
2. Fever
3. apply

154
4. favour
83. Toxicology is the science of poisons, including their source, chemical
_______, action, tests and their antidotes.
1. poison
2. Dosage form
3. palpitations
4. composition
84. One of criteria to obtain the status of OTC product in the US is that a
medication must have low potential for misuse and _____.
1. liquid
2. abuse
3. device
4. Lozenge
85. OTC Pharmaceutical products must have labelling that provides adequate
_____ for sale and effective use.
1. palpitations
2. discovery
3. Formulation
4. directions
86. __________ is an oily liquid to rub on painful body parts to reduce pain.
1. Pneumonia
2. Ailment
3. Liniment
4. Tablet
87. At present, the Food and Drug Administration is reviewing its current
______ on the number of categories of medicines.
1. Toxicity
2. policy
3. Chronic

155
4. Lozenge
88. In Canada, Behind-the-counter medicines are those that a patient can
obtain without a prescription, but only with the personal ______ of a
pharmacist.
1. involvement
2. palpitations
3. breathe in
4. discovery
89. __________ dosage forms are breathed in through mouth or nose and are
often used to treat respiratory diseases.
1. Inhaled
2. Tablet
3. Nausea
4. Lotions
90. __________ means a drug preparation that gradually releases an active
substance over a period of time.
1. Time-release delivery
2. New chemical entity
3. Chewable tablet
4. Allergic reaction

1. ____ department compounds the raw materials into drugs, packages them,
and puts in the leaflets for the patients.
a. Quality Assurance (QA)
b. Clinical Affairs
c. Production
d. Marketing and Sales
2. _____ department compounds the materials into drugs, packages them,
and puts in the leaflets for the patients.
a. Product
b. Production

156
c. Package
d. Packaging
3. ____ department finds new substances to make new drug formulations or
changes existing dosage forms, for example, from tablets to capsules.
a. Quality Assurance (QA)
b. Clinical Affairs
c. Regulatory Affairs
d. Research and Development (R&D)
4. ____ department finds new substances to make new drug formulations or
changes existing dosage forms, for example, from tablets to capsules.
a. Research and Development (R&D)
b. Researcher and Development (R&D)
c. Regulatory and Development (R&D)
d. Research and Deployment (R&D)
5. _____ department compiles the drug documentation and submits it to the
drug regulatory authorities so the company can get authorization to
market the product.
a. Quality Assurance (QA)
b. Clinical Affairs
c. Research and Development (R&D)
d. Regulatory Affairs
6. Regulatory Affairs department compiles the drug documentation and
submits it to the drug regulatory authorities so the company can get
_____.
a. authorization to conduct preclinical testing.
b. authorization to market the product.
c. authorization to market the nea chemical entity (NCE)
d. authorization to conduct in vitro testing
7. _____ department plans the promotion and distribution of drugs which
will be launched, and makes decisions about the packing or tablet colour
of new products.
a. Quality Assurance (QA)
b. Clinical Affairs
c. Research and Development (R&D)
d. Marketing and Sales

157
8. Marketing and Sales department plans _____ of drugs which will be
launched, and makes decisions about the packing or tablet colour of new
products.
a. the formulation of dosage forms
b. the production and distribution
c. the quality and quanlity
d. the promotion and distribution
9. ______ department tests or organizes testing on live subjects, and makes
sure that the drugs are safe and effective for the patients.
a. Quality Assurance (QA)
b. Clinical Affairs
c. Regulatory Affairs
d. Production
10. _____ department conducts or organizes clinical trials on live subjects,
and makes sure that the drugs are safe and effective for the patients.
a. Safety
b. Pharmacovigilance
c. Clinical Affairs
d. Regulatory Affairs
11.______ department ensures that products meet the standards which the
law requires, and contain the active ingredients advertised.
a. Regulatory Affairs
b. Research and Development (R&D)
c. Quality Assurance (QA)
d. Marketing and Sales
12.(QA) department ensures that products meet the standards which the law
requires, and contain the _____ advertised.
a. excipients
b. active ingredients
c. inactive ingredients
d. placebo
13.Dosage form is the final form of the medicine, e.g. Tablet, powder, gel,
spray, etc.
a. Dosage
b. Dose
c. Dosage form
d. Dossier

158
14.______ form is the final form of the medicine, e.g. Tablet, powder, gel,
spray, etc.
a. Dosage
b. Dose
c. Dosage form
d. Dossier
15._____ is a product which can be sold without the patient seeing a doctor.
a. Over-the couter drug
b. Prescription drug
c. Pharmaceutical products in the pipeline
d. Dosage form
16._____ are future drugs, not yet on the market.
a. Over-the couter drug
b. Prescription drug
c. Pharmaceutical products in the pipeline
d. Dosage form
17.Pharmaceutical products in the _____ are future drugs, not yet on the
market.
a. timeline
b. pipeline
c. sideline
d. deadlin
18.____ is the medicine bought in a pharmacy and requiring a written note
from the doctor.
a. Prescription drug
19.A_____ collects drug safety information after approval and reports any
serious adverse events to the health
a. Pharmacovigilance mannager
20.______ per forms clinical trials. _____ must also summarize, interpret
and process clinical data.
a. Clinical research associate
21.Clinical research associate performs ______. Clinical research associate
must also summarize, interpret and process clinical data.
a. clinical trials
22._______ operates complex scientific instruments and performs tests to
determine whether ingredients in liquids, powders, or tablets meet
requirements.

159
a. Laboratory technicians
23.Laboratory technicians ______ complex scientific instruments and
performs tests to determine whether ingredients in liquids, powders, or
tablets meet requirements.
a. operate
24.It’s the _____’s job to research, write, and edit clinical and study reports
before the pharmaceutical company submits them to regulatory
authorities. The _____ summarizes and interpret clinical data.
a. Medical writer
25.It’s the Medical writer’s job to_____ clinical and study reports before the
pharmaceutical company submits them to regulatory authorities .
a. research, write, and edit
26.A _______ co-ordinates and manages the cross-functional teams that
develop and launch a drug.
a. Project manager
27.A Project manager _____ and manages the cross-functional teams that
develop and launch a drug.
a. co-ordinates
b. compiles
c. computes
d. conducts
28.A _____is personally responsible for the quality of each product that
leaves the production line.
a. Qualified person
29.A _____is personally responsible for the quality of each product. He must
manage all the processes in production, QA, and the labs to make sure
Standard Operating are followed.
a. Qualified person
30.______ (SOPS) means a description of a working method or prcess.
a. Standard operating proceducres
31.____ are rules or laws about health.
a. Health regulations
32._______’s job is to make sure that suitable, clean containers are used to
get the product from the company to the patient.
a. Packaging technician
33.______ stands for bachelor’s degree.
a. B.S.

160
34._____ stands for bachelor’s science degree.
a. BSc
35.____ stands for master of degree.
a. M.S.
36.In the UK, to become fully qualified, pharmacists have to take an
examination to get a _____ tp practise pharmacy.
a. license
37.I ____ my PhD in Pharmaceutical Chemistry at Monash University.
a. got/received/obtained
38.But first, here is _____. The feasibility study has just been successfully
complated.
a. an update of the project
b. up-to-date of the project
c. an updated project
d. an update on the project
39.The main reason I am writing to you is to get your input on a new
product. _____ we plan to market a new prescription drug for headaches.
a. As you know
b. As far as your input is concerned
c. As far as
d. As long as
40.I _____ Johnson & Johnson in their clinical department.
a. used to work at
b. used to work on
c. did research on
d. use to work at
41.I_____ a first line worker and worked my way up to packaging
technician.
a. started as
b. used to work at
c. have experience in
d. responsible for
42.To self-medicate means:
a. To take medicine without seeking advice of a healthcare
professional.
43.CRO ____ someone to co-ordinate and perform analytical testing for
stability studies of new products.

161
a. is searching for
44.______ is a medication to reduce or eliminate pain.
a. Analgesic
45.All of the following are non-production pharmaceutical professions,
EXCEPT:
a. line worker
b. formulation scientist
c. lab technician
d. clinical research associate
46.Which of the following is NOT a form of pharmaceutical documentation?
a. Marketing claims
b. Clinical reports
c. Study reports
d. Clinical protocol
47.The feasibility study has just been successfully _____.
a. completed
48.I worked my way _____ to project manager
a. up
49.Before we close, _____ to review the action points.
a. I would like
50.We will need to fill the postion of clinical trial manager shortly. I’d
appreciate it if you could write p a job ____ with the input below and
place it in the pharmaceutical journal we normally use.
a. advertisement
51.We test or organize testing on live subjects and make sure that our drugs
are safe and ___ for the patients.
a. effective
52.Since the ____ of our successful feasibility study, we have also obtained
very encouraging preclinical data.
a. conclusion
b. confusion
c. combination
d. confession
53.Since the conclusion of our successful feasibility study, we have also
obtained very _____ preclinical data.
a. encouraging

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54.Feasibility study is an investigation to ____ the advantages, practicality,
and profitability of a proposed project.
a. determine
55.Feasibility study is a(n) ______ to determine the advantages, practicality,
and profitability of a proposed project.
a. investigation
56.A(v) _____ is a short official note that is sent by one person to another
within the same or organzation.
a. Memo
57.____ is a dry substance in the form of very small grains.
a. powder
58.I operate complex scientific intruments and perform tests to determine
whether ingredients in liquids, powder, or tablets _____.
a. meet requirements
59.According to European law, a qualified person is responsible for the
quality of each product that leaves the _____.
a. production line
60.I ______ complex scientific intruments and perform tests to determine
whether ingredients in liquids, powder, or tablets meet requirements.
a. operate
61.Unlike in many countries, you'll also find many cheerful, bright coloured
ads in magazines, which promote _____and other prescription drugs in
the US.
a. anti-depressants
1. Standard operating procedures (SOPs) are written and used by companies to
make it easier for them to follow GxP. These are a set of written instructions to
_______performance and results
A. maintain
B. neglect
C. finish
D. abandon
2. CAPA stands for ________. It is a part of the overall Quality Management
System (QMS) required for GMP.
A. Corrective Activity/Preventive Activity
B. Corrective Action/Preventive Action
C. Corrective Action/Protective Action
D. Corrective Action/Predictive Action

163
3. CAPA stands for Corrective Action/Preventive Action. It is a part of the overall
______ (QMS) required for GMP.
A. Quantity Manufacturing System
B. Quantity Management System
C. Quality Manufacturing System
D. Quality Management System
4. In the Pharmaceutical industry, GDP stands for ________.
A. Good Documentation Practical
B. Good Documentation Practice
C. Gross Domestic Product
D. Good Drug Practice
5. Proper protective clothing must be _____ at all times.
A. worn
B. use
C. carried
D. wear
6. Standard operating procedures are regularly _____
A. actualized
B. up-to-date
C. updated
D. delayed
7. Standard operating procedures (SOPs) are ________on a regular basis, often
after an audit has been carried out.
A. audited
B. validated
C. observed
D. updated
8. Why is product sampling carried out?
A. To introduce product quality
B. To introduce product quantity
C. To check product quantity
D. To check product quality
9. Any observation or _____noted by the auditors is categorized as either major,
minor, or critical.
A. fainting
B. funding
C. biding
D. finding
10.A holistic approach looks at aspects of a pharmaceutical company ______ to
make sure that the entire process meets high industry standards.

164
A. individually
B. together
C. independently
D. separately
11.Why do operational methods and procedures have to be validated?
A. To isolate products of high safety
B. To complete the inspection process
C. To isolate products of high standards
D. To complete the product recall process
12.What are the clothing guidelines for lab technicians?
A. Protective clothing must be worn at all times
B. Protective clothing shouldn’t be worn at all times
C. Protective clothing can be worn at all time
D. Protective clothing may be worn at all time
13.Choose the CORRECT statement about Quality assurance and auditing
A. All operational methods and procedures must be inspected and validated
to isolate products of high safety
B. The reason for interim testing, or product sampling, os to introduce
quality to pharmaceutical products.
C. The reason for interim testing, or product sampling, is to check quantity
of pharmaceutical products.
D. Proper documentation not only enables traceability, but also allows a
complete product recall from market, if necessary
14.Even a product that has been marketed for years might have to be _____the
market in a product recall if serious adverse reactions occur.
A. taken off
B. take of
C. taken of
D. take off
15.A few years ago, a well-known European pharmaceutical company was forced
to recall one of its drugs due to claims of product contamination. The drug
manufacturer was unable to say just how many patients were taking this drug at
the time. However, it estimated the_____ figure at over 40,000 people
A. global
B. All of the above
C. globe

165
D. globally
16.Choose the correct phrase to state the reason for the memo
A. Our goal is to…
B. Please make sure that…
C. Please confirm…
D. This memo is to advise you that…
17.A/An is a distinctive unpleasant smell.
A. odour
B. odourless
C. durian
D. genotoxic subtance
18. (QMS) is a formalized system that documents processes, procedures, and
responsibilities for achieving quality policies and objectives.
A. Quantity Manufacturing System
B. Quality Manufacturing System
C. Quantity Management System
D. Quality Management System
19.You are writing the SOP guideline to tell your employee to “perform all work
with virus-infected animals in the bio-safety cabinet”. The correct SOP guideline
is:
A. All work with virus-infected animals could be perfomed in th bio-safety
cabinet.
B. All work with virus-infected animals must be perform in the bio-safety
cabinet
C. All work with virus-infected animals could be perform in the bio-safety
cabinet
D. All work with virus-infected animals must be performed in the bio-safety
cabinet
20.Why is product sampling carried out?
A. To check product quantity.
B. To introduce product quality.
C. To introduce high industry standards.
D. To make sure SOPs are followed.
21.A(n)______is a safety device consists of a sheet of a fire retardant material which
is placed over a fire in order to extinguish it.
A. fire truck
166
B. fire blanket
C. fire extinguisher
D. fire cracker
22.Choose the correct phrase to ask for verification of some information
A. Please confirm…
B. Our goal is to…
C. This memo is to advise you that…
D. Please make sure that…
23.Inspection and validation are required to prove that the manufacturing and testing
equipments
A. functional
B. function
C. fictional
D. foundational
24.A_____considers laboratory and manufacturing processes and environments
together and not individually.
A. direct approach
B. holistic approach
C. general approach
D. quality approach
25.Choose the word means: “No longer pure”
A. Contaminate
B. Contamination
C. Contaminant
D. Contaminated
26.Choose the word that match the following definition: “Practice of checking that
goods and services follow standards.”
A. documentation
B. SOP
C. compliance
D. QA
27.According to reports, it seems that an unanticipated between the drug's active
ingredient and the chemicals used as part of the cleaning processes at the site was
the cause of the contamination.
A. creation
B. reaction
C. recreation
D. react
28.In the Pharmaceutical industry, GCP stands for
A. Good Chemical Practice
B. Good Clinician Practice
167
C. Good Clinic Practice
D. Good Clinical Practice
29.Even a product that has been marketed for years might have to be taken off the
market in a_____if serious adverse reactions occur.
A. product rebate
B. product return
C. product recall
D. product launch
30.An internal ________involves inspection and validation of operational methods,
procedures, equipment to ensure functionality, accuracy and validity.
A. audits
B. auditor
C. audit
D. auditors
31.CAPA is a part of the overall Quality Management System (QMS) required for
GMP._______ prevents recurrence of errors.
A. Preventive activity
B. Corrective activity
C. Corrective action
D. Preventive action
32.An annual audit of safety procedures in all laboratories is carried out
A. every 12 months
B. every month
C. every three months
D. every six months
33.______make sure that the health and well-being of laboratory workers are
guaranteed.
A. Safety procedures
B. Protection procedures
C. Recall procedures
D. Safety procedure
34.A genotoxic substance is
A. a chemical that repair cellular DNA, preventing mutations or cancer.
B. a substance that has toxic effects on the lungs
C. a chemical that damages cellular DNA resulting in mutations or cancer.
D. a distinctive unpleasant smell.
35.An internal audit involves inspection and ______-of operational methods,
procedures, equipment to ensure functionality, accuracy and validity.

168
A. stamping
B. sampling
C. validation
D. valuation
36.A few years ago, a well-known European pharmaceutical company was forced
to ______ one of its drugs due to claims of product contamination
A. return
B. rebate
C. resume
D. recall
37. a/an apparatus to wash the eyes after exposure to chemical contamination.
A. Eye tub
B. Eye bath
C. Eye shower
D. Eye glasses

38.Documentation is important and necessary at every step of the processes,


activities, and (s) involved in drug manufacturing.
A. operating
B. operator
C. operation
D. operational
39.All operational methods and procedures must also be inspected for
A. accurate
B. adhere
C. adverse
D. accuracy
40. is important and necessary at every step of the processes, activities, and
operations involved in drug manufacturing.
A. adherent
B. complication
C. computation
D. documentation
41.You need to __________all equipment following any experiments with
laboratory animals.
A. infectant
B. disinfect

169
C. disinfectant
D. infect
42.Please make sure that all the laboratory staff are advised and prepared standard
audit procedure.
A. in accordance
B. with accordance to
C. in accordance with
D. in accordance of
43.Which aspect of drug manufacturing enables________?
A. documentation
B. quantity control
C. quantity assurance
D. holistic approach
44.In the Pharmaceutical industry, GRP stands for
A. Good Researcher Practice
B. Good Research Practical
C. Good Recall Practice
D. Good Research Practice
45.At the end of everv staoe of a product's manufacturing process, is done to
maintain quality standards.
A. Endpoint testing
B. Product sampling
C. Quality assurance
D. Interim testing
46.Corrective action _________
A. encourages recurrence of errors
B. prevents recurrence of errors
C. prevents occurrence of errors
D. encourages occurrence of errors
47.The quality assurance ______in good manufacturing practice (GMP) includes
product quality control, sampling, and testing.
A. protest
B. progress
C. process
D. proceed
48.Manufacturing processes and procedures must go through periodic _____to
guarantee that they are still of an acceptable standard.
A. validation
B. valuation
C. radiation
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D. variation
49.This memo is _______you that your department has been scheduled for a
periodic audit of the laboratory safety systems and procedures.
A. to direct
B. to ask
C. to give
D. to advise
50.This memo is to_______you that your department has been scheduled for a
periodic audit of the laboratory safety systems and procedures.
A. advise
B. advance
C. advice
D. adviser
51.Safety procedures guarantee the _____of lab workers
A. healthy
B. time
C. safe
D. health
52.We should tell the lab staff to _______that all the labs are spotlessly clean and
that all lab devices and equipment are where they should be - at every single
workstation.
A. single-check
B. double-check
C. doable-check
D. trouble-check
53.Please confirm ______of this memo and send us a copy of all your
correspondence with regard to this scheduled audit.
A. reply
B. return
C. review
D. receipt
54.___________involves all manufacturing processes in GMP which make sure the
goods produced are kept at high standards.
A. Quality assurance
B. Product control
C. Quality testing
D. Product assurance

171
55.________mask is a device that you wear over your face in order to protect
yourself from
A. dangerous fire
B. poisonous gases
C. loud noises
D. harmful radiation
56.Choose the word that match the following definition: “A____ description of a
workinq method"
A. SOP
B. documentation
C. QA
D. compliance
57.The completed checklist and original audit results will be ______ you and the
Research and Development Vice President
A. review
B. renewed
C. reviewed
D. recalled
58.Preventive action ____________
A. prevents occurrence of errors
B. encourages occurrence of errors
C. prevents recurrence of errors
D. encourages recurrence of errors
59.In the Pharmaceutical industry, GSP stands for _______
A. Good Safety Practice
B. Good Safeway Pratice
C. Good Safety Practical
D. Good Sanitary Practice

1. She was given fluids through an ____ because she was very dehydrated.
a. P.O.
b. IV
c. SQ
d. IM
2. The patient’s ______ condition was caused by a recent injury.
a. old

172
b. current
c. past
d. pre-existing
3. New drugs are _____ on live subjects.
a. conducted per formed
b. performed
c. determined
d. tested
4. This memo is _____ you that your department has been scheduled for a
periodic audit of laboratory safety systems and procedures.
a. advice
b. advise
c. advance
d. adviser
5. _____ is important and necessary at every step of the processes,
activities, and operations involved in drug manufacturing.
a. complication
b. computation
c. adherent
d. documentation
6. A Qualified person is personally responsible for the ______ of each
product that leaves the production line. A Qualified person must manage
all the processes in production, QA, and the labs to make sure Standard
Operating are followed.
a. quantify
b. quantity
c. quality
d. qualify
7. Choose the term that does not fit in the category “non-production
pharmaceutical professions”
a. Lab technician
b. Pharmacovigilance manager
c. Line worker
d. Clinical research associate
8. _____ is an oily substance like a cream
a. Ointment
b. Capsule

173
c. Tablet
d. Ingredient
9. A _____ is a unit of volume equal to a cube whose sides are equals to
one centimeter.
a. cc
b. mEq
c. mg
d. mcg
10. The results show a high level of _____ in the urine.
a. CKD
b. albumin
c. GFR
d. BUN
11. What are the clothing guidelines for lab technicians?
a. Protective clothing shouldn’t be worn at all times.
b. Protective clothing can be worn at all times.
c. Protective clothing must be worn at all times.
d. Protective clothing may be worn at all times
12.You will need to take a pill once every hour until you start to feel better.
The underlined part has the same meaning as:
a. qh
b. qhs
c. ac
d. pc

13.The doctor will apply a gel on your stomach to perform the ______
a. ultrasound
b. urinalysis
c. endoscope
d. BUN test
14.Behind-the-counter medicine _____
a. can be purchased without a prescription but only with the
personal involvement of a pharmacist.
b. Can be not purrchared without a prescription but only with the
personal involvement of a pharmacist
c. Are prescription drugs that kept behind the pharmacist counter
d. Are non prescripstion durgs that behind te pharmacist counter
15.To ______ is to breathe with difficulty in a noisy manner.

174
a. wheeze.
16. Feasibility study is an investigation to ________
a. determine the advantages, practicality, and profitability of a
proposed project.
17.The bone is likely broken, but take a(n) ____ to make sure.
a. X-ray
18.In the Pharmaceutical industry, GLP stands for _______
a. Good Laboratory Practice.
19. A(n) ____ will reveal if Mary’s baby is a boy or girl.
a. ultrasound
20.The asthmatic patient complained of _____
a. SOB
21.Medication must meet four criteria in order to abtain the status of a non-
presciption or OTC product. Choose the CORRECT statement:
a. It must have low potential for misuse and abuse.
22.IV injection means injection of a medication directly into the ______.
a. vein
23. Mr. Hallam said that he has been taking over-the-counter medicine for
his ____.
a. procedure
b. complaint
c. history
d. cold
24. I received my master’s ___ at New York University and licence to
practice pharmacy in the United States.
a, degree
25. How should we _____ Mr. Smith’s medicine?
a. administer
26. The patient suffers from high _____ and is taking medicine for it.
a. BP
27._______is Phase-1 study in which a test product is administered to
human beings.
a. First in-man study.
28. Suppository is _______
a. a solid medicine which melts slowly in the rectum or vagina
b. a smooth greasy preparation for application to the skin for healing.
c. an oily liquid to rub on painful body parts to reduce pain.

175
d. administered by placing it under the tongue.
29.Which of the following is equal to one ml?
a. 1 cubic centimeter
30. Choose the CORRECT statement about drug categories:
a. Canada has two official categories: prescription drugs and OTC drugs
b. There are four catagories of drugs in the U.S.
c. The US has two official categories: prescription drugs and QTC
drugs
d. There are three catagories of drugs in Canada
31. ______ documentation not only enables traceability, but also allows a
complete product recall from the market, if necessary.
a. proper
32.A few years ago, a well-known European pharmaceutical company was
forced to recall one of its drug due to claims of product contamination.
The drug manufacturer was unable to say just how many patients were
taking this drug at the time. However, it estimated the global ______ at
over 40,000 people.
a. figure
33. Nurse please send this _____ to Dr. Brown.
a. pathology report
34. I have a fear of swallowing pills and for that reason my doctor always
prescribes pills that can be absorbed _______
a. Sublingually
b. Topically
c. subcutaneous
d. intravenous
35. A/an ____ is a type of topical dosage forms.
a. cream
b. drop
c. tablet
d. aerosol
36. Research and Development (R&D) department finds new ______ to
make new drug ______ or changes existing dosage forms, for example,
from tablets to capsules.
a. substances/ formulations.

176
37.Regulation affairs department compiles the drug documentation and
submits it to the drug regulatory authorities so the company can get
authorization to ______ the product.
a. market
38. ______ (QMS) is a formalized system that documents processes,
procedures, and responsibilities for achieving quality policies and
objectives.
a. Quality Management System
39. _____ is a semi-solid substance placed between the patient’s skin an
ultrasound.
a. gel
40.______ for the infection included antibiotics.
a. Rx
50. From the _____ we can see that there are no broken bones or fractures.
a. XR
51. A(n) ___ is a organized examination of a patient’s physiological state as

a. palpation
52. ____ stands for master of science degree.
a. MSc
53. Diarrhoe is a condition in which ________
a. faeces are discharged from the bowels frequently and in a
liquid form.
54. _______ is the study of the bodily absorption, distribution, metabolism,
and excretion drugs (what the body to the drug)
a. Pharmacology
55. A(n) ____ uses magnetic properties of atoms to create very detailed
pictures.
a. MRI
56. The doctor must always first conduct a genaral____ of physical body
parts.
a. percussion
57. Regulation affairs department ____ the drug documentation and submits
it to the drug regulatory authorities so the company can get authorization
to market the product.
a. compiles

177
58. In an R & D meeting, John gives the following answer: “As you know,
when substances are taken with alcohol or antibiotics, their chemical
form could change and even cause harmful side effects. I’ll keep you
informed.” What question did John answer?
a. What kind of formulation could we develop from this NCE?
59. Mensamint is a new dosage form of Mensadent ( _____ with plysician’s
prescription only)
a. obtain
60. The antibiotics were given through ____ injections.
a. subcutaneous
61. Before doing any ____ we must first know about any allergies or
previous conditions
a. Procedure
b. Allergy
c. Onset
d. complaint
62. It’s the Medical writer’s job to research, write, and edit clinical and study
reports before the pharmaceutical company submits them to regulatory
authorities .
a. clinical and study reports
63. Monika ____ to review all regulatory issues by the end of the month.
a. Would
b. will
c. is
d. should
64. Clinical research associates _____ clinical trials. They must also
summarize _____ and process clinical data.
a. perform/ regulate
65. Ben has a ____ of diabetes.
a. history
66. How do you handle the disposal of toxic waste in the lab?
a. it is disposed of in speccial bins
b. It is disposed of in bins specially.
c. It is disposed of in normal bins.
d. It is handled specially.

178
67. Marketing and Sales department ___ the promotion and distribution of
drugs which will be launched, and _____ about the packing or tablet
colour of new products.
a. plans/ makes decisions
b. plants/ makes decisions
c. makes decisions/ plans
d. makes decisions/ plants
68. Nausea is _____
a. the strong or fatal reaction to taking a large amount of drug
b. the condition of feeling sick and the feeling that you are going
to vomit.
c. the inflammation of the lungs. The lungs become filled with liquid
which makes it difficult to breathe.
d. an area of red spots that appears on your skin when you are ill or
have a bad reaction to something that you have eaten or touched.
69. ____ of cleaning processes is essential in this industry, because chemical
or bacterial contamination of drug products can potentially lead to severe
public health risks
a. Validation
70. Choose the word that match the following definition: “Practice of
checking that goods and services follow standards.”
a. SOP
71. Any observation noted by the auditors is categorized as either____.
a. major, minor, or critical
72. _____ are no longer pure and acceptable for sale or public use and,
therefore, must be returned to the manufacturer, or destroyed.
a. Contaminated drugs
b. Fake drugs
c. Illegal drugs
d. Expired drugs
73. Nurse, please inform the patient about the correct ____ of his medication.
a. injection
b. route
c. dosage
d. I.V.
74. Bronchitis is the ____ of the bronchial tubes, characterizes by coughing,
difficulty in breathing.

179
a. inflammation
75. A ____ test how well kidneys are working.
a. GFR test
76. During mosquito season, applying _____ ointment helps to relieve bites
a. topical
77. It says here the patient's ____ is headaches and dizziness.
a. complaint
78. I have a headache that ____.
a. throbs
79. In an R & D meeting, John gives the following answer: “It is already
avaibale in lozenge and chewing gum form, but we hope to develop a
time-release patch in the near future”. What question did John answer?
a. What kind of formulation could we develop from this NCE?
80. To obtain the status of a non-prescription or OTC in the Us, a drug must
have ____.
a. a large margin of safely
81. Sublingual tablet is administered by placing it _____
a. under the tongue
82. Which one of the following is NOT a route of administration?
a. Dissolution
b. Topical
c. Intravenous (IV)
d. Oral
83. Take these ____ three times a day with meals.
a. pills
84. Dosage is the ______
a. amount and frequency of a medicinal drug that may be taken
safely
b. frequency of a medicinal drug that may be taken safely.
c. amount of a medicinal drug that may be taken safely.
d. same as a dose of a medicinal drug that may be taken safely.
85. A dose is the ____
a. amount of a medicinal drug that may be taken safely.
86. A/an _____ is a solid preparation that is intended to dissolve or
disintegrate slowly in the mouth.
a. Lozenge
87. Someone who suffers from insomnia _____.

180
a. finds it difficult to sleep
88. A/an _____ is a type of topical dosage forms.
a. cream
89. An aerosol is a type of _____ dosage forms.
a. inhaled
90. _____ capsule is a type of capsule that is usaully used to contain
medicine in the form of dry powder or very small pellets.
a. Hard gelatin
91. A/an __________ is a liquid in which another substance has been
dissolved.
a. solution
92. Anaemia is _____
a. a medical condition in which there are too few red cells in your
blood, causing you to feel tired and look pale
b. the body's exaggerated immune response to an internal or surface
agent.
c. a lung condition which causes difficulty in breathing.
d. an illness, especially one that is not very serious.
93. ______ capsule is a type of capsule that usually used to contain oils and
for active ingredients that are dissolved or suspended in oil
a. Soft gelatin
94. A/an _____ is a type of inhaled dosage forms.
a. aerosol
95. You were asked to give your opinion about the in-man studies of a new
drug. Choose the INCORRECT sentence:
a. According to me, the in-man studies for this drug will take more
than six months.
96. Medication must meet four criteria in order to abtain the status of a non-
prescription or over-the counter (OTC) product. Choose the CORRECT
statement:
a. It must have low incidence of side effects
97. A cream is a type of ____ dosage forms.
a. topical
98. Medication must meet four criteria in order to abtain the status of a non-
prescription or over-the counter (OTC) product. Choose the CORRECT
statement:
a. It must have a large margin of safety

181
99. Using the right _____ is especially important when giving medicine to
children, because they often have problems swallowing pills.
a. Dosage form
b. dosage
c. dose
d. dose form

100. Liniment is ____


a. a medication on material or cloth placed on the skin.
b. a sweet, liquid medicine taken with a spoon or cup.
c. a solid preparation that is intended to dissolve or disintegrate
slowly in the mouth
d. an oily liquid to rub on painful body parts to reduce pain
41.The patient’s ______ condition was caused by a recent injury.
e. old
f. current
g. past
h. pre-existing
42.This memo is _____ you that your department has been scheduled for a
periodic audit of laboratory safety systems and procedures.
e. advice
f. advise
g. advance
h. adviser
43._____ is important and necessary at every step of the processes,
activities, and operations involved in drug manufacturing.
e. complication
f. computation
g. adherent
h. documentation
44.A Qualified person is personally responsible for the ______ of each
product that leaves the production line. A Qualified person must manage
all the processes in production, QA, and the labs to make sure Standard
Operating are followed.
e. quantify
f. quantity
g. quality

182
h. qualify
45.Feasibility study is an investigation to determine the advantages,
practicality , and ____ of a proposed project.
a. traceable
b. profit
c. traceability
d. profitability
46.Choose the term that does not fit in the category “non-production
pharmaceutical professions”
e. Lab technician
f. Pharmacovigilance manager
g. Line worker
h. Clinical research associate
47. A _____ is a unit of volume equal to a cube whose sides are equals to
one centimeter.
e. cc
f. mEq
g. mg
h. mcg
48. The results show a high level of _____ in the urine.
e. CKD
f. albumin
g. GFR
h. BUN
49.You will need to take a pill once every hour until you start to feel better.
The underlined part has the same meaning as:
e. qh
f. qhs
g. ac
h. pc
50. _____ involves interim and product sampling procedures, which are
carried out to check product quality.
a. Quality testing
b. Product control
c. Endpoint testing
d. Quality control

183
51.____ is the proportion of a drug or other substance which enters the
circulation when introduced into the body and so is able to have active
effect.
a. bioavailability
52._
53. To ______ is to breathe with difficulty in a noisy manner.
b. wheeze.
54. Feasibility study is an investigation to ________
b. determine the advantages, practicality, and profitability of a
proposed project.
55.The bone is likely broken, but take a(n) ____ to make sure.
b. X-ray
56. ______ documentation not only enables traceability, but also allows a
complete product recall from the market, if necessary.
b. proper
57.Nurse please send this _____ to Dr. Brown.
b. pathology report
58. I have a fear of swallowing pills and for that reason my … always
prescribes pills that can be absorbed _______
e. sublingually

59.
60.Regulation affairs department compiles the drug documentation and
submits it to the drug regulatory authorities so the company can get
authorization to ______ the product.
b. market
61. ______ (QMS) is a formalized system that documents processes,
procedures, and responsibilities for achieving quality policies and
objectives.
b. Quality Management System
62. ____ stands for master of science degree.
e. MSc
101. Diarrhoe is a condition in which ________
a. faeces are discharged from the bowels frequently and in a
liquid form.
102. _______ is the study of the bodily absorption, distribution,
metabolism, and excretion drugs (what the body to the drug)

184
a. Pharmacology
103. Regulation affairs department ____ the drug documentation and
submits it to the drug regulatory authorities so the company can get
authorization to market the product.
a. compiles
b.
104. Clinical research associates _____ clinical trials. They must also
summarize _____ and process clinical data.
a. perform/ regulate
105. ____ of cleaning processes is essential in this industry, because
chemical or bacterial contamination of drug products can potentially lead
to severe public health risks
a. Validation
106. Choose the word that match the following definition: “Practice of
checking that goods and services follow standards.”
a. SOP
107. Bronchitis is the ____ of the bronchial tubes, characterizes by
coughing, diffculty in breathing.
a. inflammation
108. A ____ test how well kidneys are working.
a. GFR test
109. During mosquito season, applying _____ ointment helps to relieve
bites
a. topical
110. I have a headache that ____.
a. throbs
111. To obtain the status of a non-prescription or OTC in the Us, a drug
must have ____.
a. a large margin of safely
112. A/an __________ is a liquid in which another substance has been
dissolved.
a. solution
b.
113. ______ capsule is a type of capsule that usually used to contain oils
and for active ingredients that are dissolved or suspended in oil
a. Soft gelatin
114. A/an _____ is a type of inhaled dosage forms.

185
a. aerosol
115. You were asked to give your opinion about the in-man studies of a
new drug. Choose the INCORRECT sentence:
a. According to me, the in-man studies for this drug will take more
than six months.
116. Liniment is ____
a. an oily to rub on painful body parts to reduce pain.
63.The patient’s ______ condition was caused by a recent injury.
i. old
j. current
k. past
l. pre-existing
64.This memo is _____ you that your department has been scheduled for a
periodic audit of laboratory safety systems and procedures.
i. advice
j. advise
k. advance
l. adviser
65. _____ is important and necessary at every step of the processes,
activities, and operations involved in drug manufacturing.
i. complication
j. computation
k. adherent
l. documentation
66.A Qualified person is personally responsible for the ______ of each
product that leaves the production line. A Qualified person must manage
all the processes in production, QA, and the labs to make sure Standard
Operating are followed.
i. quantify
j. quantity
k. quality
l. qualify
67.Choose the term that does not fit in the category “non-production
pharmaceutical professions”
i. Lab technician
j. Pharmacovigilance manager
k. Line worker

186
l. Clinical research associate
68.A _____ is a unit of volume equal to a cube whose sides are equals to one
centimeter.
i. cc
j. mEq
k. mg
l. mcg
69. The results show a high level of _____ in the urine.
i. CKD
j. albumin
k. GFR
l. BUN
70.You will need to take a pill once every hour until you start to feel better.
The underlined part has the same meaning as:
i. qh
j. qhs
k. ac
l. pc

71.To ______ is to breathe with difficulty in a noisy manner.


c. wheeze.
72. Feasibility study is an investigation to ________
c. determine the advantages, practicality, and profitability of a
proposed project.
73.The bone is likely broken, but take a(n) ____ to make sure.
c. X-ray

74.Nurse please send this _____ to Dr. Brown.


c. pathology report
75. I have a fear of swallowing pills and for that reason my … always
prescribes pills that can be absorbed _______
f. sublingually
76. A/an ____ is a type of topical dosage forms.
e. cream

187
77.Regulation affairs department compiles the drug documentation and
submits it to the drug regulatory authorities so the company can get
authorization to ______ the product.
c. market
78. ______ (QMS) is a formalized system that documents processes,
procedures, and responsibilities for achieving quality policies and
objectives.
c. Quality Management System
79.______ for the infection included antibiotics.
b. Rx
117. ____ stands for master of science degree.
a. MSc
118. Diarrhoe is a condition in which ________
a. faeces are discharged from the bowels frequently and in a
liquid form.
119. _______ is the study of the bodily absorption, distribution,
metabolism, and excretion drugs (what the body to the drug)
a. Pharmacology
120. Regulation affairs department ____ the drug documentation and
submits it to the drug regulatory authorities so the company can get
authorization to market the product.
a. compiles
121. Clinical research associates _____ clinical trials. They must also
summarize _____ and process clinical data.
a. perform/ regulate
122. Bronchitis is the ____ of the bronchial tubes, characterizes by
coughing, diffculty in breathing.
a. inflammation
123. A ____ test how well kidneys are working.
a. GFR test
124. During mosquito season, applying _____ ointment helps to relieve
bites
a. topical
125. I have a headache that ____.
a. throbs
126. To obtain the status of a non-prescription or OTC in the Us, a drug
must have ____.

188
a. a large margin of safely
127. Common ____ of CAREFREEDO are : nausea, vomiting,
abdomical pain.
a. side effects
128. Dose is the ____
a. amount of a medicinal drug that may be taken safely.
129. _____ capsule is a type of capsule that is usaully used to contain
medicine in the form of dry powder or very small pellets.
a. Hard gelatin
130. A/an __________ is a liquid in which another substance has been
dissolved.
a. solution
b.
131. ______ capsule is a type of capsule that usually used to contain oils
and for active ingredients that are dissolved or suspended in oil
a. Soft gelatin
132. A/an _____ is a type of inhaled dosage forms.
a. aerosol
133. You were asked to give your opinion about the in-man studies of a
new drug. Choose the INCORRECT sentence:
a. According to me, the in-man studies for this drug will take more
than six months.
134. A cream is a type of ____ dosage forms.
a. topical
62.The internal audit of the laboratory safety system is done to assure ____
with industry standads, especially for safety procedures
a. complance
63.I've told the nurses to give the patient his medicine every day ____ so that
his body will digest it easily.
a. ac
b. QOD
c. stat
d. qhs
64.Mrs. Sellers is at risk of kidney disease and her ____ function has
declined.
a. renal
b. CKD

189
c. Creatinine
d. albumin
65.Docter Greene, the patient is waiting for his ____
a. XR
66. Please give Ms. Williams 50mg of magnesium _____: morning, noon,
and night.
a. TID
67.It says here _____, so you can have painkillers as needed.
a. PRN
68.Doctors need a full ___ of the patient’s condition
a. history
69.A/an ____ is a fluid preparation (aqueous) for external application
without friction.
a. Lotion
70.After carefully reviewing our ____ we realized that all our uncles have
high blood pressure.
a. family medical history
b. complaint
c. data
d. onset
71.Which of the following is an aspect of checking vital signs?
a. evaluating posture
b. evaluating patient's mood
c. observation of the patient's body language
d. auscultation
72._____ is a condition in which faeces are discharged from the bowels
fraquently and in a liquid form.
a. Diarrhoea
73.Lozenge is ____
a. a solid preparation that is intended to dissolve or disintegrate
slowly in the mouth (e.g.. Sore throat)
74.Packaging technician's job is to_____
a. summarize, interpret and process clinical data.
75.The pediatrician at the Emergency room checked the baby’s _____ and it
read 101 degree Fahrenheit.
a. T
76.Hurry up; we are losing the patient; get a 50cc steroid injection ___!

190
a. stat
77.I _____ a first line worker and my way up to pakaging technician.
a. started as
78.I work in the Pharmacovigilance department, I collect drug safety
information about patients _____
a. for our medications
79.Clinical Affairs department conducts or organizes clinical trials on live
subjects, and makes sure that _____.
a. the placebos are safe and effective for the patients
b. the company can get authorization to market the product
c. products meet the standards which the law requires, and contain the
active ingredients advertisesd
d. the drugs are safe and effective for patients.
80.My _____ is in pharmacology.
a. Professional background
81.Toxicology is______
a. the study of poison
82. Jim has been ____ all day long. It sounds like he has a serious cold.
a. Coughing
b. Cold
c. Throbbing
d. runny
83.Choose the CORRECT statement about Quality assurance and auditing
a. The quality assurance process in good manufacturing practice
(GMP) includes product quality control, sampling, and testing.
84.Ben was _____ so bad that his chest hurt
a. throbbing
85.This could be hereditary so we’ll need to look at your ____ history.
a. family
86.Choose the word that match the following definition: “Following rules
and regulations.”
a. SOP
b. documentation
c. compliance
d. QA

87.Mary’s ______ suggest that she has got the flu and not a cold.

191
a. allergies
b. diseases
c. symptoms
d. procedures
88.________ of cleaning processes is essential in the pharmaceutical
industry, because chemical or bacterial contamination of drug products
can potentially lead to severe public health risk.
a. Validate
b. Valuate
c. Validation
d. Valuation
89.You may feel some slight discomfort when the doctor first ______ (s) the
tube into the opening.
a. injection
b. gel
c. check
d. feed
90.Toxicity is _______
a. the degree to which a substance (a toxin or poison) can harm
humans or animals.@
b. the study of drugs, how they work, and what they do in the body.
c. the study of poisons.
d. an expert in the science of poisons.
91.We are waiting for the results of the BUN test to assess the patient’s
______ function.
a. lung
b. renal
c. heart
d. liver
92.___________'s job is to make sure that suitable, clean containers are used
to get the product from the company to the patient.
a. Laboratory technician
b. Packaging technician
c. Medical writer
d. Formulation scientist
93.Geogre had a ______ nose and a high temperature.
a. throbbing

192
b. runny
c. coughing
d. wheezing
94.Asthma is _____
a. a lung condition which causes difficulty in breathing.
b. a medical condition in which there are too few red cells in your blood,
causing you to feel tired and look pale.
c. the body's exaggerated immune response to an internal or surface
agent.
d. an illness, especially one that is not very serious.
95.An allergic reaction is _____
a. the body's exaggerated immune response to an internal or surface
agent.
b. a lung condition which causes difficulty in breathing.
c. a medical condition in which there are too few red cells in your blood,
causing you to feel tired and look pale.
d. an illness, especially one that is not very serious.
96.It's the Medical writer's job to research, write, and edit clinical and study
reports ____________.
a. after regulate authorities submits them to the pharmaceutical company
b. before the pharmaceutical company submits them to regulatory
authorities
c. before regulate authorities submits them to the pharmaceutical
company
d. after the pharmaceutical company submits them to regulatory
authorities
97.Mark is experiencing ______ lately and finds it hard to go up the stairs.
a. T
b. SOB
c. XR
d. WNL
98.If a wound or a part of your body becomes septic , it becomes _______.
a. Infected
99.Bioavailability is the proportion of a drug or other substance which
______
a. enters the lungs when introduced into the body and so is able to have
an active effect.

193
b. enters the liver when introduced into the body and so is able to have
an active effect.
c. enters the kidney when introduced into the body and so is able to have
an active effect.
d. enters the circulation when introduced into the body and so is able
to have an active effect.
100. Advance notice of this meeting was very _______.
a. shortly
b. short
c. brief
d. briefly
101. ________ is a date or time by which you have to do or complete
something.
a. sideline
b. deadline
c. timeline
d. pipeline
102. John became dehydrated and had to be taken to the hospital where
he was given fluids through a(n) ______
a. IV
b. PR
c. IM
d. PO
103. At 65 beats per minute the ______ is stable.
a. T
b. BP
c. Rx
d. HR
104. Which of the following words is the opposite to “Chronic”
a. Major
b. Ailment
c. Acute
d. Minor
105. Which of the following is an advanced medical imaging technique?
a. Dx
b. X-ray
c. CT san

194
d. Rx
106. We will need to fill the position of clinical trial manager shortly.
I’d appreciate it if you could write up a job _______ with the input below
and place it in the pharmaceutical journal we normally use.
a. advertiser
b. advertise
c. adverse
d. advertisement
107. A Pharmacovigilance manager collects ______ information after
approval and reports any serious _______ to the health authorities.
a. drug safety/ adverse affects
b. drug safety/ adverse events
c. drug efficacy/ adverse events
d. drug safely/ adverse events
108. A Pharmacovigilance manager collects drug safety information
_________ and reports any serious adverse events to the health
authorities.
a. for approval
b. before approval
c. after approval
d. during approval
109. When substances are taken with alcohol or antibiotics, their
chemical form could change and even cause harmful ___________.
a. side effects
b. side ways
c. side affects
d. side actions
110. Toxicologist is _______
a. the study of drugs, how they work, and what they do in the body.
b. the study of poisons.
c. an expert in the science of poisons.
d. the degree to which a substance (a toxin or poison) can harm
humans or animals.
111. The last temperature reading indicated that the patient had (a)
______
a. fever

195
112. __________ tablet is chewed prior to swallowing. It is designed for
administration to children e.g. vitamin products.
a. chewable
113. Mr. Brinks might need a mild sedative to sleep, so give him some
Sommel2 ______.
a. X
114. The doctor collected enough ______ on the patient’s health and
now he can make a diagnosis.
a. allergy
b. complaint
c. data
d. onset
115. We plan ______ our new drug in Asia first and to apply for Food
and Drug Administration (FDA) approval in the US the following year.
a. to launch
116. I ________ the initial conceptual design phase.
a. was involved in
b. was involved on
c. started as
d. used to work at
117. My son takes 1 ____ of Omega-3 fish oil every day before his
meal.
a. mEq
b. kg
c. Tbsp
d. g
118. The initial ____ was that the patient has an anxiety disorder.
a. HR
b. BP
c. Dx
d. Rx
119. Why do operational methods and procedures have to be validated?
a. To make sure products perform their intended function
b. To isolate products of high quality
c. To isolate products of high quantity
d. To complete the product recall process
120. Choose the correct phrase to state the objective of a course of
action
a. Our goal is to…
196
b. Please make sure that…
c. This memo is advise you that…
d. Please confirm…
121. An internal audit is ____ of Good Lab Practice (GLP)
a. Rarely a part
b. Not a rarely a part
c. A regular part
d. Not a regular part
122. Doctors must collect accurate ____ in order to have important
details about their patients.
a. complaints
b. data
c. allergy
d. onset
123. ____ the patient seems to have breathing problems.
a. c/o
b. SOB
c. o/e
d. WNL
124. As soon as you see the victim, check first all the ____ .
a. vital signs
b. percussion
c. palpation
d. body language
125. Choose the CORRECT statement:
a. A Pharmacovigilance manager collects drug safety information
before approval and reports any serious adverse events to the
health authorities.
b. A Project manager coordinates and manages the cross-
functional teams that develop and launch a drug.
c. A Property manager coordinates and manages the cross-functional
teams that develop and launch a drug.
d. A Clinical research associate performs clinic trials. Clinical
research associate must also summarize, interpret and process
clinical data.

197
126. You are writing the SOP guideline to tell your employee to “Wipe
up all chemical spills in the laboratory immediately”. The correct SOP
guideline is
a. All chemical spills in the laboratory must be wipe up immediately
b. All chemical spills in the laboratory must be wiped up immediately
c. All chemical spills in the laboratory could be wiped up immediately
d. All chemical spills in the laboratory could be wipe up immediately
127. You ________ review data in accordance with Good
Manufacturing Guidelines.
a. will need to be able to
b. are required
c. are searching for
d. are essential to
128. Which aspect of drug manufacturing enables traceability?
a. quantity assurance
b. documentation
c. holistic approach
d. quantity control
129. Aerosol is ________
a. a semi-solid emulsion, that is mixtures of oil and water.
b. a kind of medicine that you put in your eyes one drop at a time.
c. a drug delivery system consisting of a semi-solid, jelly-like
substance.
d. a container with a liquid that is administered in spray form.
130. Who most likely to be examined by an ultrasound?
a. A patient who is pregnant
b. A patient with abnormal heart activity
c. A patient in surgery
d. A patient with a broken bone
131. Choose the word that is similar in meaning to the underlined part
The doctor performed an investigation of the patient’s ear
a. Percussion
b. Palpation
c. Inspection
d. Ansculation
132. Graham is having difficulty breathing and is ___ a lot.
a. Wheezing

198
b. Cold
c. Runny
d. Throbbing
133. New chemical entity is a unique, _____ that has never previously
been synthesized or used to treat disease
a. Pharmacologically active product
b. Pharmacologically inactive product
c. Pharmacologically active placebo
d. Pharmacologically inactive placebo
134. We were taught ____ techniques for the organs beneath the
abdomen
a. Palpitation
b. Percussion
c. Inspection’
d. Observation
135. Clinical Affairs department ____ or organizes clinical trials on live
subjects, and makes sure that the drugs are safe and effective for the
patients
a. complies
b. compounds
c. computers
d. conducts
136. I now work in Milan but _____ to be based in Boston.
a. I’m used
b. I use
c. I used
d. I was used
137. Dr. Holmes has ordered the nurses on call to administer 300___of
antibiotics to Mr. Woods every 12 hours
a. Mcg
b. g
c. tsp
d. tbsp.
138. Gather information about the patient’s ____ history by asking
about routines and habits
a. Onset
b. Procedure

199
c. Social
d. Complaint
139. The ______ options include diet and lifestyle changes
a. XR
b. HTN
c. Rx
d. WNL
140. A CT scan uses many two-dimensional_____ (s) to create a three-
dimensional image.
a. Light
b. Sound wave
c. X-ray
d. Magnetic force
141. Quick, give her an adreanaline injection____, we are losing her!
a. qhs
b. stat
c. pc
d. ac
142. Research and Development (R&D) department finds new
substances to make new drug formulations or changes existing ____, for
example, from tablets to capsules.
a. dosage forms
b. doses
c. dossiers
d. dosages
143. _____your input _____, we need the financial data from your
department as soon as possible
a. As long as…is concerned
b. As long as…is concern
c. As far as…is concerned
d. As far as….is concern
144. Diarrhoea is a condition in which _____
a. faeces are discharged from the bowels frequently and in a solid
form.
b. faeces are discharged from the bowels frequently and in a
liquid form.

200
c. faeces are discharged from the kidneys frequently and in a solid
form.
d. faeces are discharged from the kidneys frequently and in a liquid
form.
145. Why do operational methods and procedures have to be validated?
Choose the INCORRECT answer:
a. To complete the inspection process
b. To isolate products of high quality.
c. To complete the quality assurance process.
d. To make sure products perform their intended function.
146. A specialist or expert in the scientific field of chemistry is called a
______________, also known as a pharmacist in the US. *
a. chemical
b. chemist
c. chemistry
d. pharmacy
147. The science of poisons, including their source, chemical
composition, action, tests, and even their antidotes, is what we call
______________. *
a. toxic
b. toxicity
c. toxicologist
d. toxicology

148. If a drug or medicine is not available ‘over-the-counter’, it


normally means that a _________________ from a physician is needed to
obtain it from a pharmacy. *
a. prescription
b. prescribe
c. dosage form
d. dose

149. Chemists and pharmacologists are also interested in how the


medicine is administered, so they often ask about its ______________. *
a. formulate
b. dose form

201
c. formulation
d. formula

150. Before drugs or medicines can be made available to the public,


they have to be tested on human beings. We call this a(n)
______________________ . It is also called a phase l, stage I study, or
clinical trial. *
a. First man study
b. First In-men study
c. First In-man study
d. In-man study
151. From the notes, it seems the onset of symptoms started after
moving house.
Select one:
a. current
b. family
c. onset
d. social
152. A gas mask is a device that you wear over your face in order to
protect yourself from __.
a. poisonous gases
b. loud noises
c. harmful radiation
d. dangerous fire
153. _____ are very common during spring.
A. Allergies
B. Illnesses
C. Pains
D. Diseases
154. Only trained medical professionals can ____ this injection.
A. admit
B. administer
C. administration
D. admission
155. I ______ clinical methodology.
A. did research to
B. did research on

202
C. did research in
D. did research of
156. If a wound or a part of your body becomes ________ , it becomes
infected.
A. nauseated
B. septic
C. hot
D. inflamed
157. Good morning, and welcome everyone. Great that everyone on the
project team could make it to our ______ meeting.
A. kick-of
B. kick-in
C. kick-up
D. kick-off
158. Pharmaceutical products in the pipeline are ______
A. OTC drugs that are currently on the market
B. behind-the-counter drugs that are currently on the market
C. drugs that are being recalled from the market
D. future drugs, not yet on the market.
159. Is there any connection between your past medical history and the
______ condition?
A. data
B. procedure
C. onset
D. current
160. An MRI uses ______ of atoms to produce an image of the body.
A. magnetic forces
B. sound waves
C. light
D. X-ray
161. The antibiotics are ____, so that’s 3 times a day.
A. QOD
B. TID
C. QID
D. BID
162. __________is any health problem which starts while on a new
medicine.

203
A. Adverse event
B. Adverse problem
C. Toxic event
D. Side affect
163. Diabetes refers to a group of diseases ____
A. that affect how your body uses blood protein
B. that affect how your body uses blood albumin
C. that affect how your body uses blood fat
D. that affect how your body uses blood glucose
164. A patch is ______
A. a medication on material or cloth placed on the skin.
B. a small, round piece of medicine to be swallowed without chewing.
C. a solid medicine which melts slowly in the rectum or vagina.
D. administered by placing it under the tongue.
165. All toxic substances ____ be disposed of properly.
A. could
B. may
C. can
D. must
166. Creatinine ____ are higher than normal.
A. levels
B. ate
C. BUN
D. Pressure
167. Over-the-counter drug is a product which _______
A. can only be sold with a prescription
B. is the same as behind-the-counter drug
C. can be sold without the patient seeing a doctor.
D. can not be sold without the patient seeing a doctor.
168. Please go to the radiology department immediately for a(n) ____ .
A. physical examination
B. pathology report
C. injection
D. x-ray
169. The ____ taken by oral thermometer at 9pm was 96.2 °F.
A. HR
B. Rx

204
C. T
D. BP
170. ________ is the amount of a medicinal drug that may be taken
safely at one time.
A. Dosage form
B. Dose
C. Dosage
D. Dose form
171. Quick, give her an adrenaline injection ____, we are losing her!
A. stat
B. ac
C. pc
D. qhs
172. Mr. Burton should have two ____ of Dextromethorphan by mouth
twice a day.
A. c/o
B. mEq
C. kg
D. Tbsp
173. Ointment is a(n) ___ substance like a cream
A. solid
B. oil
C. soil
D. oily
174. A CT scan uses many two-dimensional ______ (s) to create a
three-dimensional image.
A. light
B. magnetic force
C. sound wave
D. x-ray
175. X-rays and CT scans use radiography to take pictures, while
ultrasounds use the reflection of _____.
A. endoscope
B. MRI
C. ECG
D. sound waves
176. A holistic approach looks at _____

205
A. aspects of a pharmaceutical company separately to make sure that
the entire process meets high industry standards.
B. aspects of a pharmaceutical company individually to make sure
that the entire process meets high industry standards.
C. aspects of a pharmaceutical company independently to make sure
that the entire process meets high industry standards.
D. aspects of a pharmaceutical company together to make sure
that the entire process meets high industry standards.
177. If the patient’s temperature rises above 100.3 degrees Fahrenheit
give him a 25 cc injection of antibiotics and call me ________
A. Ac
B. Pc
C. Stat
D. GOD
178. Why is product sampling carried out? Choose the INCORRECT
answer:
A. To check product quality
B. To introduce product quality
C. To make sure SOPs are followed
D. To meet high industry standards.
179. Nowaday a(n)___________is the most accurate method to measure
the heart’s electrical activity.
A. X-ray
B. ECG
C. GFR test
D. MRI

85 câu hỏi nhiều lựa chọn

1. _________ Government agencies, pharmaceutical companies, and


healthcare professionals work together to monitor and evaluate suspected side
effects of medicines to improve the safety of drugs in use.

1. Pharmacovigilance
2. Drug Safety
3. marketing authorization
4. Pharmacopeia
2. ______ means the specialized language used by people in the same work/
profession or industry.
206
1. abdominal
2. confusion
3. jargon
4. fatal
3. If you have a history of heart trouble, ______ your doctor before taking
this medicine.

1. confusion
2. consult
3. monitor
4. accompanied
4. Symptoms of __________ include: red, warm, and swollen.

1. Hypertension
2. contraceptive
3. intestines
4. Inflammation
5. It has the same packaging, same colour coating, same bitter _______, but
not the same ingredients inside the pill. Is this a fake drug?

1. accompanied
2. frequency
3. elevated
4. aftertaste
6. A _______ between Mensamint and the symptoms cannot be ruled out.

1. correlation
2. agitation
3. confusion
4. sedative
7. __________ department is responsible for monitoring and evaluating
suspected side effects, reporting an adverse drug reaction to health authorities,
and responding to a physician's report.

1. Drug Safety
2. preservative
3. Pharmacovigilance
4. Hypotension

207
8. Our patients shouldn't be so alarmed that they are afraid to actually put
the pills in their mouth and swallow them. The PIL just needs to reflect the
_______ of side effects.

1. authenticity
2. Vital signs
3. probability
4. aftertaste
9. Abdominal pain is the pain in your stomach or ______.

1. Inflammation
2. abdominal
3. dizziness
4. intestines
10. Do not take Penicillin if you are allergic to any ______(s).

1. abdominal
2. antibiotic
3. Inflammation
4. aftertaste
11. When describing possible side effects for products in the pipeline, we will
need to ______more clearly between frequent and rare risks.

1. preservative
2. despite
3. differentiate
4. Side effect
12. __________ (SAE) is an adverse event that threatens life, requires or
prolongs hospitalization, or results in death.

1. Serious adverse event


2. experience
3. active pharmaceutical ingredient
4. QPPV
13. The patient has an _____ to peanuts.

1. probability
2. Itching
3. hay fever
4. allergy
208
14. _____ is a seasonal allergy to pollens.

1. contraceptive
2. allergy
3. hay fever
4. disprove
15. After examining the patient, the _______ reduced the dosage to 10 mg
per day .

1. attending physician
2. differentiate
3. Active substance
4. dizziness
16. ____ drugs may contain: a worthless placebo; a lower concentration of
the same active ingredient; a similar, but different substance; a totally different,
potentially dangerous substance.

1. coating
2. fake
3. pollen
4. faint
17. _____ side effects of CAREFREEDO are: nausea, vomiting, abdominal
pain (pain in your stomach or intestines)

1. dossier
2. despite
3. common
4. conduct
18. Serious adverse event (SAE) - an adverse event that threatens life,
requires or prolongs _______, or results in death.

1. experience
2. hospital admission
3. Adverse event
4. hospitalization
19. ____ is a drug used to make someone calm or go to sleep.

1. contraceptive
2. abdominal
3. hay fever
209
4. sedative
20. The ________ is an executive agency of the Department of Health in the
United Kingdom which is responsible for ensuring that medicines and medical
devices work and are acceptably safe.

1. faint
2. EMEA
3. MHRA
4. FDA
21. Someone has a ___________, that person has a lot of spots on the skin.

1. Rash
2. brief
3. Serious adverse event
4. hospital admission
22. A _____ accident or illness causes someone's death.

1. abdominal
2. PILs'
3. Itching
4. fatal
23. __________ is any unintended reaction caused by a drug or medical
treatment. This term is used by the general public, but is often avoided by
medical authorities.

1. Excipient
2. Itching
3. Counterfeit
4. Side effect
24. __________ is when blood pressure is lower than normal (e.g. A blood
pressure of 65/70).

1. Hypotension
2. Pharmacopeia
3. Side effect
4. correlation
25. Ms Gallois, the well-known opera singer, lost _______ 30 minutes before
she had planned to go on stage. ( = the condition of being awake and able to
understand what is happening around you)
210
1. preservative
2. inconclusive
3. consciousness
4. confusion
26. __________ stands for Qualified Person Responsible for
Pharmacovigilance.

1. brief
2. Serious adverse event
3. high-profile
4. QPPV
27. _________ means patient information leaflets.

1. pollen
2. fatal
3. PILs'
4. hay fever
28. hypertension means high _______.

1. blood pressure
2. Out of reach
3. Inflammation
4. hay fever
29. As to her _____state after hospital admission,the patient showed side
effects of hyperactivity, accompanied by confusion and a feeling of agitation.

1. probability
2. discharge
3. accompanied
4. emotional
30. The evidence is inconclusive.The facts neither prove nor ____ this.

1. hay fever
2. disprove
3. confused
4. discharge
31. __________ is when you feel like you want to scratch.

1. Hypertension

211
2. Excipient
3. Side effect
4. Itching
32. The number of counterfeit drugs is on the rise, not only in developing but
also in ______ country

1. industrialized
2. preservative
3. dizziness
4. Excipient
33. Mensamint is a lozenge to support increased concentration. The active
substance is mensagitatum. Other ingredients are peppermint, oil, sugar, talcum,
and ______.

1. preservative
2. probability
3. industrialized
4. aftertaste
34. __________ department is responsible for compiling dossiers for
submission to authorities, submitting documents needed to obtain marketing
approval for a drug, and writing the drug information for the patient.

1. contraceptive
2. Pharmacovigilance
3. Regulatory Affairs
4. healthcare professionals
35. _________ stands for (active pharmaceutical ingredient)

1. Hypotension
2. API
3. fake
4. sedative
36. Regulatory Affairs department is responsible for compiling the ________
for submission to drug regulatory authorities.

1. despite
2. dossier
3. consult
4. coating

212
37. _____ more international co-operation in the fight to stop counterfeit
drugs, some countries have unfortunately not taken action.

1. pollen
2. despite
3. disprove
4. jargon
38. When describing possible side effects for products in the pipeline, we will
need to differentiate more clearly between _____ and rare risks

1. preservative
2. frequent
3. pollen
4. elevated
39. At the hospital, the patient showed evidence of hyperactivity,
accompanied by ______ and agitation.

1. confusion
2. agitation
3. Hypotension
4. consult
40. PHARMACOVIGILANCE - Government agencies, pharmaceutical
companies, and __________ work together to monitor and evaluate suspected
side effects of medicines to improve the safety of drugs in use.

1. probability
2. attending physician
3. healthcare professionals
4. monitor
41. At the hospital, the patient showed evidence of hyperactivity ,
accompanied by confusion and _______.

1. Hypotension
2. agitation
3. correlation
4. confusion
42. In order to get approval to sell a new drug, a company has to _____
detailed documentation with all the information required by the drug authorities

213
1. conduct
2. consult
3. leaflet
4. compile
43. ____ is an official document issued by the drug regulatory authority for
the purpose of marketing or free distribution of a product after evaluation for
safety, efficacy and quality.

1. Counterfeit
2. Regulatory Affairs
3. marketing authorization
4. Drug Safety
44. ____________ is an official publication containing a list of medicinal
drugs with their effects and directions for their use.

1. contraceptive
2. Pharmacopeia
3. Hypotension
4. Side effect
45. When you talk about PILs, say each letter. If not, it might be _____with
'pills'

1. accompanied
2. dizziness
3. frequent
4. confused
46. The __________ is the Food and Drug Administration (US) It is
responsible for ensuring that food, drugs, and certain other products and
processes are safe for consumers.

1. FDA
2. advent
3. MHRA
4. EMEA
47. _____ pain is the pain in your stomach or intestines.

1. fatal
2. Excipient
3. hay fever

214
4. abdominal
48. ____ is a fine powder produced by flowers, which is carried by the wind
or by insects to other flowers of the same type, making them produce seeds.

1. despite
2. pollen
3. conduct
4. fake
49. The ___________ is a European Union agency for the evaluation of
medicinal products.

1. FDA
2. dizzy
3. EMEA
4. MHRA
50. If you ______, you lose consciousness for a short time, especially
because you are hungry, or because of pain, heat, or shock.

1. faint
2. advent
3. fake
4. consult
51. In rare cases, CAREFREEDO may cause the following side effects:
______ blood pressure, dizziness, allergic reactions...

1. elevated
2. frequent
3. discharge
4. preservative
52. Fake drug may have the same packaging, same colour _______, same
bitter aftertaste, but not the same ingredients inside the pill.

1. conduct
2. dizziness
3. coating
4. consult
53. Mensamint may cause _______.(a sensation of spinning around and
losing one's balance)

215
1. dizziness
2. dizzy
3. intestines
4. concomitantly
54. In Europe, steps have been taken to use holograms to prove a
pharmacopeias ______.

1. contraceptive
2. authenticity
3. inconclusive
4. aftertaste
55. Keep out of ______ of children.

1. alarm
2. reach
3. Out of reach
4. allergy
56. Iris Berger from HR will place job ads in several major pharmaceutical
journals to look for two new clinical research associates to ______ the trials in
the test centres in France.

1. conduct
2. frequent
3. common
4. dossier
57. Although the evidence is _______, a reaction to Mensamint cannot be
completely ruled out.

1. authenticity
2. concomitantly
3. contraceptive
4. inconclusive
58. Important information for any person taking a drug can be found in the
_________.

5. brief
6. patient information leaflet
7. leaflet
8. high-profile

216
59. The patient's normal __________ (pulse, blood pressure, respiratory rate
and temperature) are established in the pre-operative period and variations 10%
above or below the pre-operative measurement should be reported immediately.

1. probability
2. Side effect
3. Vital signs
4. history
60. Better styling in the PIL could increase______.

1. inconclusive
2. Pharmacopeia
3. Inflammation
4. patient compliance
61. ____ is an inactive substance that serves as the vehicle or medium for a
drug or other active substance.

1. Excipient
2. contraceptive
3. sedative
4. frequent
62. With the _______ of online pharmacies, open borders and uncontrolled
chemical laboratories all over the world, the number of counterfeit drugs is on
the rise, not only in developing but also in industrialized countries.

1. emotional
2. advent
3. conduct
4. faint
63. ______ is a drug or method used to prevent a woman from becoming
pregnant when she has sex.

1. Inflammation
2. contraceptive
3. authenticity
4. industrialized
64. Do not take Mensamint TM if you are _______ to peanut.

1. disprove

217
2. Allergic
3. allergy
4. elevated
65. A ______ person or a _______ event attracts a lot of attention or
publicity. (= famous)

1. contraceptive
2. Hypotension
3. authenticity
4. high-profile
66. If you feel _______, you feel that you are losing your balance and are
about to fall.

1. dizzy
2. EMEA
3. confused
4. consult
67. Government agencies, pharmaceutical companies ,and healthcare
professionals work together to _____and evaluate suspected side effects of
medicines to improve the safety of drugs in use

1. despite
2. history
3. monitor
4. conduct
68. We do need to let patients know of any possible side effects. But, it is not
necessary to _____them unnecessarily.

1. elevated
2. common
3. faint
4. alarm
69. Important information for any person taking a drug can be found in the
'PIL'or patient information _____.

1. hospital admission
2. consult
3. leaflet
4. elevated

218
70. __________ means general discomfort, bad feeling.

1. active pharmaceutical ingredient


2. Adverse event
3. Serious adverse event
4. Irritation
71. Pharmaceutical companies use details from doctors' reports to inform the
authorities in a ______.

1. Hypertension
2. case report
3. agitation
4. Excipient
72. Adverse event is an unwanted medical occurrence which a patient
_____(s) during treatment. This may or may not be a side effect of a drug.

1. experience
2. Irritation
3. Serious adverse event
4. compile
73. __________ is when blood pressure is higher than normal (e.g. A blood
pressure of 140/90)

1. Hypertension
2. contraceptive
3. correlation
4. Side effect
74. The patient has a ______ of hypertension, mild heart palpitations, high
adrenalin levels,and often suffers from insomnia.

1. concomitantly
2. coating
3. history
4. discharge
75. At the hospital, the patient showed evidence of hyperactivity , _______
by confusion and agitation.

1. accompanied
2. Excipient
3. authenticity
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4. case report
76. The 'Possible side effects' section of a Patient Information leaflet
categorizes known side effects according to their ______.

1. frequency
2. history
3. frequent
4. aftertaste
77. After 24 hours, all symptoms except for a mild skin irritation had
subsided and the patient was_____(ed) from hospital.

1. agitation
2. accompanied
3. discharge
4. inconclusive
78. You investigate the adverse event by looking for similar side effects in
the documentation and report it to the authorities. Still, nothing even vaguely
similar can be found for either the ______(API) or any of the excipients.

1. active pharmaceutical ingredient


2. Active substance
3. Ras
4. hospital admission
79. I just wanted to give you a _____ update on the self-inspection conducted
last week by QA

1. hospital admission
2. patient information leaflet
3. compile
4. brief
80. __________ is an unwanted medical occurrence which a patient
experiences during treatment. This may or may not be a side effect of a drug.

1. QPPV
2. Adverse event
3. Serious adverse event
4. hospitalization
81. The __________ of Mensamint TM is mensagitatum. Other ingredients
are peppermint, oil, sugar, talcum, and a preservative.
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1. EMEA
2. Active substance
3. Regulatory Affairs
4. Hypertension
82. _________ drugs may contain: a worthless placebo; a lower
concentration of the same active ingredient; a similar, but different substance; a
totally different, potentially dangerous substance.

1. Hypotension
2. Drug Safety
3. Pharmacopeia
4. Counterfeit
83. Keep _________ of children.

1. Active substance
2. Out of reach
3. Pharmacopeia
4. reach
84. As to her emotional state after ________, the patient showed evidence of
hyperactivity, accompanied by confusion and a feeling of agitation.

1. hospital admission
2. high-profile
3. agitation
4. brief
85. The patient was ______ taking the following medication:Mimifem oral
contraceptive pill and Mensamint.

1. concomitantly
2. Active substance
3. probability
4. dizziness
1.

1.

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2. In the preclinical stage of drug development, a(n) ______ must be tested
extensively in the laboratory. This is to ensure it will be safe to administer to
humans.

1. experimental drug
2. effectiveness
3. investigational drug
4. administer
3. __________ means quick to detect or respond to slight changes, or
influences. e.g. Dogs are more __________ to drugs than mini-pigs.

1. Shortly
2. Illness
3. Sensitive
4. Phase IV
4. The general health of the dogs was regularly checked. On Day 2,
abnormalities regarding food ______ were observed shortly after administration
in the high-dosegroup.

1. observation
2. consumption
3. indication
4. authority
5. A __________ assists chemists and chemical engineers using chemicals
and related products

1. Chemistry lab technician


2. Phase IV
3. Sensible
4. Biology lab technician
6. A _______ in preclinical studies is a group of test animals that is not
exposed to the medication under study. In an experiment, this group is treated
just like the other animals, but does not receive the active ingredient. This group
is then compared with the treated animals in order to validate the results of the
test.

1. act on
2. causal relationship
3. Control group

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4. Absorption
7. The safety and efficacy of a drug can only be determined by conducting
_____ clinical trials, according to the FDA.

1. Illness
2. commence
3. rigorous
4. response
8. Phase III is the final phase before getting marketing ________.

1. approval
2. disorder
3. evidence
4. appearance
9. __________ is the first phase in which patients with the target disease or
disorder take part.

1. Phase I
2. Effect
3. Phase II
4. Phase IV
10. Many terminally ill people fall victim to the therapeutic _______ that the
objective of trials is to cure them.

1. concentration
2. legal right
3. indication
4. misconception
11. During the preclinical developmentof a drug,laboratory tests document
the effect of the investigational drug in living ______,and in cells in a test tube
(in vitro).

1. Metabolism
2. Phase II
3. response
4. organism
12. Toxicology is the study of the _______risks to the body.

1. Phase III

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2. observation
3. potential
4. intention
13. Regulatory agencies require testing that documents the characteristics -
chemical composition,purity quality,and _______ -of thedrug's active
ingredient,and of the formulated drug. (= strength)

1. commence
2. healthy
3. potency
4. Disease
14. The dogs started retching and vomiting and were separated to allow
closer ______.

1. observation
2. authorization
3. concentration
4. abnormality
15. In phase__________ , further information regarding drug's safety,
efficacy, and the ideal(optimal) use of the drug is collected.

1. Phase III
2. Phase I
3. Phase II
4. Phase IV
16. Drug __________ describes the chemical reactions catalysed by enzymes
that change drugs into compounds which are easier to eliminate.

1. organism
2. Sensitive
3. Excretion
4. Metabolism
17. Phase I Trials: These are studies which are performed to evaluate the
safety of drugs in ______ people, and to determine the pharmacological
properties of drugs.

1. healthy
2. Phase II
3. indication

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4. evaluate
18. Subjects in a trial must be willing to be _______ assigned to either the
group which receives the unapproved medication or the one which gets a
placebo

1. response
2. healthy
3. evaluate
4. randomly
19. Adverse reaction refers to all abnormal and unintended _____to an
investigational medicinal product related to any dose administered.

1. disorder
2. randomly
3. response
4. Sensible
20. Test subjects in the treatment group receive the medication under study,
whereas the control group receives either a standard medication or a _____.

1. behaviour
2. Phase I
3. placebo
4. exposure
21. The products of drug metabolism are called _____.

1. authorization
2. legal right
3. Metabolites.
4. potential
22. Phase II clinical trial is performed after there is _____evidence that the
drug is effective.

1. legal right
2. effectiveness
3. indication
4. preliminary
23. Do terminally ill patients have the ______ to try to prolong their lives by
taking experimental drugs?

225
1. misconception
2. fall victim to
3. legal right
4. appropriate
24. Drug __________ is the removal of a drug or its metabolites from the
body.

1. Excretion
2. Phase I
3. Phase III
4. Sensitive
25. __________ means "in living organisms"

1. in vivo
2. Sensitive
3. Phase IV
4. Illness
26. The safety and ______ of a drug can only be determined by conducting
rigorous clinical trials, according to the FDA.

1. efficacy
2. affect
3. Briefly
4. evidence
27. Phase III Trials: A large group of patients is studied and closely
monitored by physicians for efficacy and any adverse events after long-term
____ to the drug.

1. exposure
2. consumption
3. behaviour
4. authority
28. Phase II is the first phase in which patients with the target disease or
______ take part.

1. Phase IV
2. disorder
3. approval
4. appearance

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29. Clinical trials are mainly aimed at answering scientific questions. In
general, their goal is to gather statistics to determine whether an ______ is safe
and effective.

1. effectiveness
2. impromptu
3. experimental drug
4. investigational drug
30. In __________ the drug reacts in the body, toxicity, metabolism,
absorption, and excretion are observed and documented.

1. Illness
2. Phase III
3. Phase II
4. Phase I
31. __________ means 'soon'. e.g. The adverse event occurred shortly after
the injection.

1. Phase II
2. Shortly
3. Phase I
4. Phase IV
32. In addition, the overall ______ and behaviour of each animal was
assessed twice a day

1. appearance
2. abnormality
3. legal right
4. intention
33. __________ are semi-solid emulsion, that is mixtures of oil and water.

1. Illness
2. Phase III
3. Excretion
4. Creams
34. The results of all testing must be provided to the FDA in the United
States and/or other appropriate regulatory agencies in other countries in order to
____ permission to begin clinical testing in humans.

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1. clinical
2. efficacy
3. obtain
4. potency
35. In phase _________, testings are done to determine the safety and
efficacy of the drug in treating the condition and establishes the minimum and
maximum effective dose.

1. Phase II
2. Phase III
3. Phase IV
4. Phase I
36. In the preclinical stage of drug development, an investigational drug must
be tested extensively in the laboratory. This is to ensure it will be safe to
_____to humans.

1. impromptu
2. investigational drug
3. clinical
4. administer
37. The results of all testing must be provided to the FDA in the United
States and/or other appropriate regulatory agencies in other countries in order to
obtain permission to begin ______ testing in humans.

1. rigorous
2. potency
3. approval
4. clinical
38. The parents of a 21-year-old woman challenged the FDA.They took the
_______ to court after their daughter had died of cancer.

1. exposure
2. consumption
3. placebo
4. authority
39. __________ means 'for a short time' . e.g. The trial director spoke
__________ to his staff about the current status of the trial.

1. Shortly

228
2. Briefly
3. Illness
4. Sensitive
40. __________ is used to describe a person who is in a poor state of health.
e.g. He missed five days of work because of _________.

1. Phase I
2. Illness
3. in vivo
4. Sensitive
41. Drug __________ is the movement of a drug from its site of
administration into the blood.

1. Adverse event
2. Absorption
3. Control group
4. Distribution
42. __________(s) regarding food consumption were observed shortly after
administration in the high- dose group.

1. Sensitive
2. abnormality
3. Sensible
4. Briefly
43. A __________ works with living organisms.

1. Biology lab technician


2. in vitro
3. Shortly
4. Adverse reaction
44. A drug that is intended to______ the sinuses may be formulated as a
time-release capsule, or as a nasal spray.

1. cancer
2. Effect
3. act on
4. response
45. The active ingredient can be tested in humans only after these tests have
been successfully completed and _______ has been given.
229
1. concentration
2. appropriate
3. misconception
4. authorization
46. An adverse event is any abnormal medical occurrence in a patient or
clinical trial subject after a ________ product has been administered.

1. Phase III
2. medicinal
3. Adverse event
4. causal relationship
47. Many terminally ill people _____ the 'therapeutic misconception that the
objective of trials is to cure them.

1. investigational drug
2. preliminary
3. fall victim to
4. effectiveness
48. ______ is a serious disease in which cells in a person's body increase
rapidly in an uncontrolled way, producing abnormal growths.

1. Illness
2. cancer
3. CMC
4. Phase I
49. An __________ is any abnormal medical occurrence in a patient or
clinical trial subject after a medicinal product has been administered. It does not
necessarily have a causal relationship with the medicinal product.

1. medicinal
2. authority
3. placebo
4. Adverse event
50. __________ is performed after there is preliminary evidence that the drug
is effective to obtain additional information to evaluate the overall benefit-risk
relationship of the drug.

1. Illness
2. Phase II

230
3. Phase III
4. Phase I
51. Phase IV Trials: They are carried out in order to ____ further information
about the drug's safety, efficacy, and optimal use.

1. healthy
2. gather
3. evaluate
4. cancer
52. _______ stands for Chemistry, Manufacturing and Controls. It is a part of
new pharmaceutical product application to the US Food and Drug
Administration.

1. CMC
2. Phase I
3. cancer
4. Effect
53. __________ is the result of a change. e.g. I felt the __________ of the
new ointment right away.

1. Effect
2. affect
3. Phase II
4. Illness
54. The general health and ______ of the dogs were checked twice a day.

1. behaviour
2. placebo
3. observation
4. exposure
55. Phase III is the final phase before getting ______.

1. effectiveness
2. potential
3. marketing approval
4. approval
56. An adverse event is any abnormal medical occurrence in a patient or
clinical trial subject after a medicinal product has been administered. It does not
necessarily have a ______ with the medicinal product.
231
1. medicinal
2. Absorption
3. consumption
4. causal relationship
57. In __________, a large group of patients is studied and closely monitored
by physicians for efficacy and any adverse events after long-term exposure to
the drug.

1. Control group
2. Distribution
3. Phase III
4. Absorption
58. Regulatory agencies have to give permission to ______ with the clinical
testing in humans, which is also done at our company.

1. response
2. efficacy
3. commence
4. Phase IV
59. __________ is the post-marketing study after getting approval for general
sale.

1. Creams
2. Phase IV
3. Phase III
4. Disease
60. _______ refers to all abnormal and unintended responses to an
investigational medicinal product related to any dose administered.

1. authorization
2. abnormality
3. Adverse reaction
4. Sensitive
61. A __________ is an abnormal condition that affects the body of an
organism, often caused by pathogens. e.g. There is a history of lung
__________ in the family.

1. Phase IV
2. Disease

232
3. Sensitive
4. evaluate
62. __________ is performed to evaluate the safety of drugs in healthy
people, and to determine the pharmacological properties of drugs

1. Phase III
2. Disease
3. Phase I
4. Phase IV
63. An adverse event is any _____ medical occurrence in a patient or clinical
trial subject after a medicinal product has been administered .

1. abnormal
2. causal relationship
3. medicinal
4. Distribution
64. First of all, it is the _______ of the company to complete the preclinical
trials by the end of the year.

1. concentration
2. observation
3. potential
4. intention
65. Low-dose/mid-dose/high-dose groups are three groups of animals which
receive different _______(s) of the medication understudy.

1. commence
2. concentration
3. fall victim to
4. benefit-risk
66. ____________ refer to the testing of an investigational drug, a procedure,
or another medical treatment in the laboratory to ensure it will be safe to
administer to humans. (also called preclinical development)

1. Preclinical studies
2. Briefly
3. Chemistry lab technician
4. experimental drug
67. __________ is the final phase before getting marketing approval.
233
1. Phase IV
2. Phase II
3. Phase III
4. Sensible
68. __________ means "in cells in a test tube"

1. in vitro
2. Sensible
3. Sensitive
4. Shortly
69. The parents took the authority to _____ after their daughter had died of
cancer.

1. court
2. affect
3. Effect
4. Shortly
70. Phase II is performed after there is preliminary _____ that the drug is
effective.

1. evidence
2. approval
3. Phase IV
4. preliminary
71. Phase I Trials: These are studies which are performed to ____ the safety
of drugs in healthy people and to determine the pharmacological properties of
drugs.

1. evaluate
2. indication
3. Phase II
4. efficacy
72. Phase II Trials are controlled studies conducted to evaluate the ______ of
the drug in a particular indication and to determine possible side effects and
risks.

1. effectiveness
2. preliminary
3. evaluate

234
4. gather
73. Extensive documentation must be provided to the _______ regulatory
authorities.

1. appropriate
2. administer
3. Phase IV
4. Excretion
74. Phase II Trials: These are controlled studies conducted to evaluate the
effectiveness of the drug in a particular _______ and to determine possible side
effects and risks

1. effectiveness
2. indication
3. evaluate
4. administer
75. After gaining evidence that the drug is effective, these controlled and
uncontrolled trials are carried out to obtain additional information to evaluate
the overall ______ relationship of the drug.

1. indication
2. effectiveness
3. benefit-risk
4. legal right
76. __________ means practical and reasonable. e.g. It was a __________
decision to cancel the trial.

1. Sensible
2. in vivo
3. abnormality
4. in vitro
77. The active ingredient currently being tested seems to ______the kidneys.

1. affect
2. evidence
3. gather
4. efficacy

235
78. Miki has been invited to join an ______ lab meeting about drug substance
MPP 010098, which is being tested in dogs. ( = without planning or organizing
it in advance.)

1. intention
2. impromptu
3. rigorous
4. response
2. Drug __________ is the movement of drugs throughout the body after
absorption.

1. Control group
2. Phase III
3. Distribution
4. Abnormal

180. ______ from a physician indicating that a woman had fainted after
developing a sudden, severe skin rash and inflammation all over her
body.
A. The patient reported
B. Vital signs
C. Suspected
D. A report was received
181. The FDA is ______
A. a federal agency within the U.S. Department of Health and
Human Services. It is responsible for ensuring that food, drugs,
and certain other product and
B. an executive agency of the Department
C. a state agency within U.S.
D. an executive agency of the Department
182. A(n) _____ pain is the pain in your stomach or intestines.
A. abdomen
B. stoma
C. abdominal
D. abnormal
183. API stands for _____
A. active pharmaceutical ingredient
B. activated pharmaceutical ingredient
236
C. active pharmacy ingredient
D. active pharmaceutical interaction
184. _____ , the attending physician discontinued Mensamint and
administered a strong sedative.
A. After releasing the patient
B. After sending the patient home
C. After discharging the patient
D. After examining the patient
185. Pharmacovigilance is the practice of monitoring the effects of
medical drugs _________
A. after they have been licensed for use, especially in order to
identify and evaluate previously unreported adverse reactions.
B. after they have been licensed for use, especially in order to identify
and evaluate previously unreported indications.
C. before they have been licensed for use, especially in order to identify
and evaluate previously unreported adverse reactions.
D. before they have been licensed for use, especially in order to identify
and evaluate previously unreported indications.
186. Drug metabolism describes the chemical reactions catalysed by
enzymes that change drugs into compounds which are easier to _______ .
A. eliminate
B. adsorb
C. distribute
D. absorb
E.
187. Adverse reaction refers to all abnormal and unintended responses
to an investigational medicinal product. It is _______
A. unaffected by the dose administered.
B. related to the dose administered.
C. independent of the dose administered
D. not related to the dose
188. Side effect is any unintended reaction caused by a drug or medical
treatment. This term ______
A. is the same as serious adverse reaction.
B. is used by the general public, but is often avoided by doctors.
C. is used by the general public and the medical authorities.

237
D. is used by the general public, but is often avoided by medical
aut
189. A control group in preclinical studies is a group of test animals that
is _______
A. not exposed to the placebo under study.
B. not exposed to the medication under study.
C. exposed to the medication under study.
D. exposed to the active pharmaceutical ingredient (API) under study.
190. _______studies that are conducted on whole, living organisms,
usually animals, including humans, and plants as opposed to a partial or
dead organism.
A. in vivo
B. test-tube
C. in vitro
D. clinical
191. In vivo studies that are conducted on _______
A. cells
B. dead organisms
C. biological molecules
D. living organisms
192. During the preclinical _______ of a drug, laboratory tests
document the effect of the investigational drug in living organisms (in
vivo), and in cells in a test tube (in vitro)
A. deployment
B. formulation
C. trial
D. development
193. The results of preclinical testing are used by experts in
pharmaceutical methods to determine how to best ________ the drug for
its intended clinical use
A. formulate
B. administer
C. development
D. test
E.
194. The results of all testing must be provided to the _______ in the
United States and/or other appropriate regulatory agencies in other

238
countries in order to obtain permission to begin clinical testing in
humans.
A. FDA
B. MHRA
C. CMC
D. QPPV
E.
195. The results of all testing must be provided to the _______ in the
United Kingdom and/or other appropriate regulatory agencies in other
countries in order to obtain permission to begin clinical testing in
humans.
A. MHRA
B. QPPV
C. FDA
D. CMC
196. Regulatory agencies have to give ______ before clinical testing can
be conducted in humans.
A. information
B. permission
C. inform
D. permit
E.
197. Extensive documentation must ______ to the appropriate
regulatory authorities.
A. be used
B. be determined
C. be provided
D. be conducted
E.
198. A drug intended to act on the skin can ______ as a cream.
A. formulated
B. be used
C. be formulated
D. formulate
E.
199. The requirements of drug _______determine how it will be
administered to humans.

239
A. biography
B. biomedical
C. bioavailability
D. biology
E.
200. Could somebody please fill me______ what the problem is ?
A. in on
B. on
C. in
D. up
201. ________ trials are studies which are performed to evaluate the
safety of drugs in healthy people, and to determine the pharmacological
properties of drugs
A. Phase II
B. Phase III
C. Phase I
D. Phase IV
202. _______ trials are controlled studies conducted to evaluate the
effectiveness of the drug in a particular indication and to determine
possible side effects and risks. In this phase, testing determines the safety
and efficacy of the drug in treating the condition and establishes the
minimum and maximum effective dose.
A. Phase II
B. Phase IV
C. Phase I
D. Phase III
203. ______ is performed after there is preliminary evidence that the
drug is effective.
A. Phase I
B. Phase IV
C. Phase II
D. Phase III
204. Phase IV trials are _______ studies after getting approval for
general sale. They are carried out in order to gather further information
about the drug’s safety, efficacy, and optimal use.
A. post-research
B. post-marketing

240
C. post-development
D. pre-marketing
205. Phase I trials are studies which are performed to evaluate the safety
of drugs in _______, and to determine the pharmacological properties of
drugs
A. large group of patients
B. volunteers and a number of patients
C. healthy people
D. small group of patien
206. Dogs are more ______ to drugs than mini-pigs
A. effective
B. sensible
C. affected
D. sensitive
207. Choose the INCORRECT statement about clinical trials:
A. Subjects in a trial are randomly assigned to either the group which
receives the unapproved medication or the one which gets a
placebo.
B. Clinical trials are aimed at gathering statistics to determine whether
an experimental drug is safe and effective.
C. Clinical trials are mainly aimed at providing medication to
terminal ill patients.
D. Pharmaceutical company which is sponsoring the clinical trial can
stop the trial at any time.
E.
208. Participating in clinical trials is a good way to _______ some extra
money
A. win
B. become
C. earn
D. keep
E.
209. The overall _______ of the drug must be evaluated
A. profit-risk
B. benefit-risk
C. deficit-risk
D. cost-risk

241
210. A control group receives either standard medication or a ______
A. placenta
B. platelet
C. placebo
D. plasma
211. An inert tablet is called______
A. platelet
B. placenta
C. plasma
D. placebo
212. Phase III is performed after there is preliminary evidence that the
drug is effective to obtain additional information to evaluate the overall
______ of the drug.
A. benefit-risk relation
B. benefit-risk creation
C. benefit-risk relationship
D. benefit-risk reaction
E.
213. Phase IV Trials: They are carried out in order to ____ further
information about the drug’s safety, efficacy, and optimal use.
A. connect
B. collect
C. gathering
D. A&B are correct
214. The parents of a 21-year-old woman challenged the FDA.They
took the authority ____ after their daughter had died of cancer.
A. of court
B. in court
C. at court
D. to court
215. The Drug Safety department is responsible for:
A. Writing the drug information for the patient.
B. Submitting documents needed to obtain marketing approval for a
drug.
C. Compiling dossiers for submission to authorities.
D. Reporting an adverse drug reaction to health authorities.
E.

242
216. The Regulatory Affairs department is NOT responsible for:
A. Submitting documents needed to obtain marketing approval for a
drug.
B. Writing the drug information for the patient.
C. Compiling dossiers for submission to authorities.
D. Reporting an adverse drug reaction to health authorities.
E.
217. The Regulatory Affairs department is NOT responsible for:
A. Writing the drug information for the patient.
B. Responding to a physician’s report about adverse drug
reactions.
C. Compiling dossiers for submission to authorities.
D. Submitting documents needed to obtain marketing approval for a
drug.
E.
218. The Drug Safety department is responsible for:
A. Compiling dossiers for submission to authorities.
B. Writing the drug information for the patient.
C. Submitting documents needed to obtain marketing approval for a
drug.
D. Responding to a physician’s report about adverse drug
reactions.
E.
219. The Regulatory Affairs department is responsible for:
A. Reporting an adverse drug reaction to health authorities.
B. Responding to a physician’s report about adverse drug reactions.
C. Monitoring and evaluating suspected side effects.
D. Compiling dossiers for submission to authorities.
220. The Drug safety department is NOT responsible for:
A. Responding to a physician’s report about adverse drug reactions.
B. Reporting an adverse drug reaction to health authorities.
C. Monitoring and evaluating suspected side effects.
D. Compiling dossiers for submission to authorities.
221. __________ is the practice of monitoring the effects of medical
drugs after they have been licensed for use, especially in order to identify
and evaluate previously unreported adverse reactions.
A. Pharmacology

243
B. Pharmaceutics
C. Pharmacovigilance
D. Pharmacokinetics
222. __________ is the practice where government agencies,
pharmaceutical companies, and healthcare professionals work together to
monitor and evaluate suspected side effects of medicines to improve the
safety of drugs in use.
A. Pharmaceutics
B. Pharmacovigilance
C. Pharmacokinetics
D. Pharmacology
223. A _________ threatens life, requires or prolongs hospitalization, or
results in death.
A. serious adverse event
B. serious adverse action
C. serious adverse affect
D. serious side affect
224. Someone has a(n) ___________, that person has a lot of red spots
on the skin.
A. hypertension
B. rash
C. palpitation
D. insomnia
225. ________is an uncomfortable sensation in the skin that feels as if
something is crawling on the skin and makes the person want to scratch
the affected area.
A. Insomnia
B. Itching
C. Inflammation
D. Infection
E.
226. When someone has a blood pressure of 80/60, that person has
________
A. Hypertension
B. Hypotension
C. Hypoglycemia
D. Hyperglycemia

244
227. ________ is/are the feelings of having rapid, fluttering or pounding
heart, triggered by stress, exercise, medication or, rarely, a medical
condition.
A. Heart inflammation
B. Heartburn
C. Heart irritation
D. Heart palpitations
E.
228. Choose the word that has the same meaning as “sleeplessness"
A. irritation
B. insomnia
C. inflammation
D. itching
229. A report received from the patient’s sister indicated that she had
________ of hypertension.
A. reduced
B. a history
C. experienced
D. recovered
E.
230. After having taken Mensamint, the patient _______(ed) headaches
and insomnia.
A. recover
B. express
C. feel
D. experience
231. __________ not having had anything to eat but a chocolate candy
bar 4 hours beforehand.
A. The patient reporting
B. The patient
C. The patient reported
D. The patient report
E.
232. After 24 hours, __________ except for a mild skin irritation and
the patient was released from hospital.
A. all drugs had subsided
B. all symptoms had subsided

245
C. all dosages had subsided
D. all medications had subsided
E.
233. A correlation between the patient's peanut allergy and this adserse
event cannot _______.
A. be ruled off
B. ruled out
C. be ruled out
D. be out
234. ______ is a Qualified Person Responsible for Pharmacovigilance.
A. FDA
B. EMEA
C. MHRA
D. QPPV
E.
235. Choose the sentence with the same meaning as “ Maybe the side
effect was a result of taking this product."
A. The side effect could have been due to taking this product.
B. The side effect is due to pre-existing conditions.
C. The evidence of the side effect is conclusive.
D. The side affect could have been due to taking this product.
E.
236. In order to get approval to sell a new drug, a company has to
compile detailed documentation with all the information required by the
drug authorities. Administrative Data include(s):
A. biological, chemical, and pharmaceutical documentation with
manufacture, quality control, and testing data
B. documentation about clinical trials and postmarketing information
C. overviews of quality, clinical, and non-clinical data
D. general information, such as the marketing authorization
application form, as well as product characteristics and
labelling
237. In order to get approval to sell a new drug, a company has to
compile detailed documentation with all the information required by the
drug authorities. Non-clinical Study Reports include(s):
A. documentation about clinical trials and postmarketing information
B. overviews of quality, clinical, and non-clinical data

246
C. study reports, pharmacology, pharmacokinetics, toxicology,
and references
D. biological, chemical, and pharmaceutical documentation with
manufacture, quality control, and testing data
238. What does “PIL” mean?
A. Patient information leaflet
B. An oral tablet
C. Oral contraceptive tablet
D. A small, round piece of medicine to be swallowed without
chewing.
239. Important information for any person taking a drug can be found
in:
A. Patient information sheet
B. Patient leaflet
C. All of the above
D. Package insert
E.
240. A patient can find Important information about a drug in:
A. All of the above
B. Patient leaflet
C. Patient information sheet
D. Patient information leaflet
241. Choose the INCORRECT statement about Counterfeit drugs:
A. Counterfeit drugs may contain a lower concentration of the same
active ingredient
B. Counterfeit drugs may contain a totally different, potentially
dangerous substance.
C. Counterfeit drugs are not fake drugs
D. Counterfeit drugs may contain a worthless placebo.
242. A child may find a pill hard to _____.
A. chew
B. eat
C. swallow
D. drink
243. If symptoms _______, the patient should consult a doctor.
A. resist
B. persist

247
C. consist
D. insist
E.
244. This medicine has a bitter ______.
A. afterthought
B. aftertaste
C. beforetaste
D. aftertest
245. The patient had a _______ condition when he took the medication.
A. adverse
B. side
C. ailment
D. pre-existing
E.
246. The patient's normal __________ signs (pulse, blood pressure,
respiratory rate and temperature) are established in the pre-operative
period and variations 10% above or below the pre-operative measurement
should be reported immediately.
A. Vital
B. Vial
C. Viral
D. Vitality
247. Our patients shouldn’t be so alarmed that they are afraid to actually
put the pills in their mouth and swallow them. The PIL just needs to
reflect the _______ of side effects.
A. probability
B. traceability
C. bioavailability
D. profitability
E.
248. Choose the sentence with the same meaning as "Will it cause
problems for other products?"
a. Would it jeopardizing other products?
b. Could it jeopardizing other products?
c. Would it jeopardized other products?
d. Could it jeopardize other products?
249. The Regulatory Affairs department is NOT responsible for:

248
A. Submitting documents needed to obtain marketing approval for a
drug.
B. Compiling dossiers for submission to authorities.
C. Monitoring and evaluating suspected side effects.
D. Writing the drug information for the patient.
250. Do not take this medicine if you are _______ to any antibiotics.
A. allergen
B. allergies
C. allergic
D. allergy
251. Regulatory Affairs department is responsible for compiling the
________ .
A. dose for submission to drug companies
B. dosage for submission to pharmacies
C. degree for submission to drug regulatory authorities
D. dossier for submission to drug regulatory authorities
252. In order to get approval to sell a new drug, a company has to
compile detailed documentation with all the information required by the
drug authorities. Administrative Data include(s):
A. general information, such as the marketing authorization
application form, as well as product characteristics
B. documentation about clinical trials and post-marketing information
C. overviews of quality, clinical, and non-clinical data
D. biological, chemical, and pharmaceutical documentation with
manufacture, quality control, and testing data
253. Side effect is any _______ reaction caused by a drug or medical
treatment. This term is used by the general public, but is often avoided by
medical authorities.
A. pharmacological
B. random
C. intended
D. unintended

69 câu hỏi nhiều lựa chọn

1. A __________ system sucks up the excess powder.

A. align
B. vacuum

249
C. demand
D. reliable
2. Slide container system is a container with three buttons that must be
____(ed) in order to slide off the lid .

A. closure
B. align
C. vacuum
D. reliable
3. A(n) __________ is an aerosol dispensing device which releases
medication into the mouth of the patient. The medication is breathed deeply into
the lungs, or stays in the mouth or throat.

1. Inhaler
2. syringe
3. sachet
4. discard
4. In the _________, the ingredients are mixed to create a wet mixture.

1. sticky label
2. Security
3. Granulator
4. moisture
5. The granules are air-dried in the __________.

1. guidelines
2. Fluid bed dryer
3. humidity
4. elderly-accessible
6. A first layer must be peeled off a blister before the drug can be pushed
through the second layer.

1. peel-push system (Container system)


2. squeeze-screw (Container system)
3. slide (Container system)
4. pain relieving
7. A _____ must be worn at all times in this area to protect your head.

1. humidity

250
2. Security
3. premises
4. hard hat
8. If someone is ______(d) of a crime, they are found guilty of that crime in
a law court.

1. lab coat
2. moisture
3. Hoist
4. convict
9. Nowadays, RRB is a research-driven,innovative pharmaceutical ___ that
develops new drugs, produces them, prepares them for sale, and markets them
worldwide.

1. enterprise
2. uniformity
3. individual
4. effervescent
10. _____ is a machine/ mechanism which releases its contents in defined
amounts.

5. Security
6. premises
7. Tablet press
8. dispenser
11. Because of her son's death, the young mother _____(ed) that safe-
disposal boxes be included in the packages of medicated patches.

9. align
10. community service
11. vacuum
12. demand
12. A sachet is a small ______ bag containing an individual dose of the
medicine. It often has a lengthwise perforation which can be torn open.

13. desiccant
14. disposable
15. accessible
16. negligence

251
13. Which primary packaging is the most suitable for nose drops?

1. tube
2. mould
3. bottle
4. granule
14. A(n) __________ is a type of single-use plastic container, and is used for
pharmaceutical products as well as for other consumer goods. The product is
placed in the formed cavity and sealed by lidding foil. The product is removed
by pushing it through the foil.

1. desiccant
2. sticky label
3. Primary packaging
4. blister pack
15. A lot of research is done to make packaging childproof,i.e. a child cannot
open it alone. However, at the same time, the elderly must have easy access to
their medication,i.e.it needs to be elderly-_______.

1. accessible
2. desiccant
3. enterprise
4. overdose
16. A four year old boy was found dead after he had stuck a highly potent,
______ patch to his leg.

1. negligence
2. overdose
3. uniformity
4. pain relieving
17. A __________ holds the pressed tablets until it is time to coat them.

1. drum
2. syringe
3. hard hat
4. Security
18. A __________ loosens the excess powder.

1. Safety

252
2. sachet
3. shaker
4. granule
19. A jar is a multi-use glass container with a twist-on lid. It can hold
pharmaceuticals, or any kind of fluids or solids. It can be opened and closed
several times until the contents are used up. Sometimes a desiccant is integrated
into the ______ so that the contents remain dry.

1. catch
2. foil
3. cap
4. content
20. The boy's death highlighted a problem that no one had _______(d) up to
that time .

1. anticipate
2. reliable
3. calibrate
4. align
21. A closure must be pushed down before it can be unscrewed.

1. push-screw (Container system)


2. squeeze-screw (Container system)
3. poke (Container system)
4. slide (Container system)
22. _______ tablets are uncoated tablets containing substances that react in
the presence of water and give off carbon dioxide.

1. effervescent
2. Secondary packaging
3. uniformity
4. negligence
23. Pharmaceutical companies have to comply with GMP ____.

1. guidelines
2. granule
3. premises
4. Granulator
24. __________ protect hands from chemical compounds
253
1. childproof
2. Primary packaging
3. rubber gloves
4. Fluid bed dryer
25. __________ is the material which is in direct contact with the product.

1. humidity
2. Secondary packaging
3. rubber gloves
4. Primary packaging
26. A(n) __________ is a piece of paper attached with adhesive to the
primary packaging to identify it and give details concerning its ownership,
nature, and/or use.

1. Safety goggles
2. sachet
3. sticky label
4. Granulator
27. The dried granules are stamped into a _____ to form tablets.

1. granule
2. moisture
3. mould
4. Sieve
28. The dried granules are stamped into a mould to form tablets in the
__________.

1. Safety goggles
2. mould
3. Tablet press
4. elderly-accessible
29. A(n) __________ is a needle attached to a plastic tube used for putting
medicine into the body or removing blood.

1. sachet
2. syringe
3. Inhaler
4. sticky label
30. The ______ is removed by the hot air in the fluid bed dryer.

254
1. granule
2. premises
3. humidity
4. moisture
31. GMP covers how to design and construct buildings so that the flow of
materials is ______(ed), and so that they can be cleaned easily.

1. overdose
2. negligence
3. disposable
4. optimize
32. During the manufacturing process, technicians also check the samples for
content uniformity, ______, and so on.

1. Safety goggles
2. comply with
3. content weight
4. Secondary packaging
33. A few years ago, a mother was convicted of negligence leading to her
son's death. It was claimed that he had died from a pain medication _____.

1. accessible
2. overdose
3. optimize
4. disposable
34. A container with three buttons that must be aligned in order to slide off
the lid.

1. slide (Container system)


2. poke (Container system)
3. squeeze-screw (Container system)
4. pain relieving
35. The elderly must have easy access to their medication,i.e.it needs to be
__________.

1. effervescent
2. elderly-accessible
3. Primary packaging
4. poke (Container system)

255
36. Pharmaceutical companies have to ______ GMP guidelines

1. comply with
2. childproof
3. Security
4. content weight
37. _________ is the amount of water vapor in the air

1. moisture
2. premises
3. Safety
4. humidity
38. __________is the protection from threats, such as attacks or crime.

1. Security
2. lab coat
3. hard hat
4. Primary packaging
39. A few years ago, a mother was convicted of _______ leading to her son's
death. ( = Failure to take proper care over something/someone)

1. pain relieving
2. negligence
3. disposable
4. individual
40. Please mind the _____ substances, which could cause severe burns.

1. calibrate
2. corrosive
3. Security
4. premises
41. __________ means a child cannot open it alone.

1. Primary packaging
2. rubber gloves
3. Security
4. childproof
42. A drum holds the pressed tablets until it is time to ______ them

1. Hoist
256
2. catch
3. coat
4. polite
43. In order to receive valid and _____ results, all devices and methods have
to undergo a validation process.

1. align
2. reliable
3. closure
4. vacuum
44. Safe-disposal boxes should be included in the packages of medicated
patches. These boxes should have a small slit at the top to _____ used patches
and it should be impossible to open them.

1. desiccant
2. Inhaler
3. discard
4. individual
45. __________ are used to protect your eyes are you work in the lab such as
chemical splashes/spills.

1. Primary packaging
2. Safety goggles
3. lab coat
4. rubber gloves
46. A closure must be squeezed between two fingers before it can be
unscrewed.

1. calibrate
2. Tablet press
3. Primary packaging
4. squeeze-screw (Container system)
47. A jar is a multi-use glass container with a twist-on lid. It can hold
pharmaceuticals, or any kind of fluids or solids. It can be opened and closed
several times until the contents are used up. Sometimes a _____ is integrated
into the cap so that the contents remain dry.

1. desiccant
2. disposable

257
3. lab coat
4. content
48. __________ is the freedom from danger or harm.

1. Safety
2. moisture
3. shaker
4. humidity
49. In the _________, As the tablets go up a spiral, they are shaken, and the
excess powder is vacuumed off. The pressed tablets are put into a drum and
stored until it is time to coat them.

1. sticky label
2. Inhaler
3. Granulator
4. Excess powder remover
50. If you give instructions in a very direct way, it may not sound _____.

1. coat

2. bottle

3. polite

4. calibrate

51. Lab equipment should always be clean or sterile and ______(d) before
using it.

1. calibrate
2. moisture
3. Tablet press
4. lab coat
52. __________ is any packaging material that is not in direct contact With
the product.

1. Secondary packaging
2. lab coat
3. childproof
4. humidity

258
53. A blister pack is a type of single-use plastic container, and is used for
pharmaceutical products as well as for other consumer goods. The product is
placed in the formed cavity and sealed by lidding ______. The product is
removed by pushing it through the ____.

1. cap
2. Hoist
3. mould
4. foil
54. Dry ingredients are weighed and transported to the granulator by the
__________.

1. Hoist
2. humidity
3. premises
4. coat
55. __________ protects the scientist and the scientist's clothes from
hazardous or hot chemicals

1. Secondary packaging
2. hard hat
3. Safety goggles
4. lab coat
56. A(n) __________ is a small disposable bag containing an individual dose
of the medicine. It often has a lengthwise perforation which can be torn open.

1. sticky label
2. syringe
3. Inhaler
4. sachet
57. A tube that can only be released by an adult-length finger by pushing an
internal catch.

1. poke (Container system)


2. catch
3. squeeze-screw (Container system)
4. Excess powder remover
58. A mother was sentenced to several years' ________ for leaving a used
medical patch in a place where her young son could have access to it.

259
1. community service
2. vacuum
3. anticipate
4. align
59. In a "push-screw" container system, a _______ must be pushed down
before it can be unscrewed.

1. align
2. closure
3. moisture
4. reliable
60. ______ is a place where company has its offices and/ or factories.

1. polite
2. premises
3. hard hat
4. moisture
61. A sachet is a small disposable bag containing a(n) ______ dose of the
medicine. It often has a lengthwise perforation which can be torn open.

1. enterprise
2. individual
3. uniformity
4. desiccant
62. A jar is a multi-use glass container with a twist-on lid. It can hold
pharmaceuticals, or any kind of fluids or solids. It can be opened and closed
several times until the ______(s) are used up. Sometimes a desiccant is
integrated into the cap so that the _______(s) remain dry.

1. enterprise
2. polite
3. content
4. blister pack
63. A(n) __________ is a multi-use glass container with a twist-on lid. It can
hold pharmaceuticals, or any kind of fluids or solids. It can be opened and
closed several times until the contents are used up. Sometimes a desiccant is
integrated into the cap so that the contents remain dry.

1. blister pack

260
2. cap
3. syringe
4. jar
64. The dried ____(s) are stamped into a mould to form tablets.

1. bottle
2. mould
3. granule
4. premises
65. Which primary packaging is the most suitable for ointments?

1. bottle
2. mould
3. tube
4. granule
66. The wet granules are pressed through a _________ on their way to the
fluid bed dryer.

1. catch
2. mould
3. Sieve
4. polite
67. A tube that can only be released by an adult-length finger by pushing an
internal ______.

1. polite
2. hard hat
3. catch
4. coat
68. Well, we have to make sure that there are no ______(s) (mistake) of
materials throughout the whole manufacturing process.

1. Sieve
2. mix-up
3. individual
4. optimize
69. During the manufacturing process, technicians also check the samples for
content _______, content weight, and so on.

261
1. disposable
2. content weight
3. individual
4. uniformity
254. Choose the CORRECT heading for the following session of the
PIL: "Mensamint is a lozenge to support increased concentration. Regular
use can lead to a marked improvement of both short-term and long-term
memory and logical thinking skills."
A. What the product is, and what it is used for
B. Before you take this product
C. Read this leaflet carefully because it contains information you need to
know
D. Possible side effects
255. A(n) fatal accident or illness causes someone's death. The antonym
of fatal is:
A. minor
B. major
C. critical
D. factual
256. The first step in conducting a physical exam is making sure that the
patient is __ and that the examination environment is optimal.
A. compliance
B. complaint
C. comfortable
D. compile
257. A/an __ is a type of oral dosage forms.
A. spray
B. tablet
C. cream
D. aerosol

258. The excess powder is loosened by a _______.


a. sieve
b. dryer
c. drum
d. shaker

262
259. Choose most suitable expression to complete the following
sentence. _________ the safety film, I will give you more detailed
information on the company.
A. While
B. Meanwhile
C. During
D. By the time
260. Dry ingredients are weighed and transported to the _______ by the
hoist.
A. drum
B. sieve
C. dispenser
D. granulator
261. The clothing specifications _______ documented.
A. didn't use to
B. didn't use to be
C. use to
D. use to be
262. Which primary packaging would you recommend for ointments?
A. bottle
B. tube
C. inhaler
D. sachet
263. In order to receive valid and reliable results, all devices and
methods have to undergo a validation process. Choose the word that has
the same meaning with "reliable"
A. dependable
B. inadequate
C. reality
D. unstable
264. Primary packaging is the material which is ________.
A. the final consumer packaging.
B. in direct contact with the product.
C. the final product packaging.
D. not in direct contact with the product.
265. In a ______ container system, a closure must be pushed down
before it can be unscrewed.

263
A. squeeze-screw
B. peel-push
C. slide
D. push-screw
266. Our documentation must be improved to _____ the requirements of
the regulatory authorities.
A. find
B. like
C. met
D. meet
267. Choose most suitable expression to complete the following
sentence.
_________, the company only had one product.
A. Nowadays
B. When it was founded
C. By the time
D. In the meantime
268. If something is _______, it is the most up-to-date model
incorporating the latest and best technology.
A. newest-of-the-art
B. state-of-the-art
C. latest-of-the-art
D. best-of-the-art
269. In a squeeze-screw container system, a closure must be ________
before it can be unscrewed.
A. squeezed between two fingers
B. aligned between two fingers
C. pushed down between two fingers
D. slided between two fingers
270. What type of packaging material is a syringe?
A. Secondary
B. Tertiary
C. Primary
D. Both primary and secondary
271. The company _____ only produce effervescent powder.
A. used to
B. use to be

264
C. use to
D. used to be
272. The company's _______ regulations didn't use to be so strict.
A. secure
B. safe
C. securely
D. safety
273. Choose most suitable expression to complete the following
sentence. _________, requirements have reached a very high standard.
A. When it was founded
B. By the time
C. In the meantime
D. In the past
E.
274. Choose most suitable expression to complete the following
sentence. _________, the company only had one production site.
A. By the time
B. Nowadays
C. When it was founded
D. In the mean
275. Choose most suitable expression to complete the following
sentence. _________ the tour is finished, you will have seen the most
important production areas.
A. While
B. Once
C. During
D. Meanwhile

276. The company’s safety regulations _____ so strict.


A. use to
B. didn’t use to be
C. use to be
D. didn’t use to
277. The company’s _______ regulations didn’t use to be so strict.
A. safety
B. securely
C. secure

265
D. safe
278. In the _____, the dried granules are stamped into a mould to form
tablets.
A. granulator
B. tablet press
C. fluid bed
D. sieve
E.
279. Secondary packaging is the material which is ________.
A. in direct contact with the product.
B. not in direct contact with the product.
C. the final consumer packaging.
D. the final product packaging.
280. A jar is _______
A. a type of single-use plastic container, and is used for
pharmaceutical products as well as for other consumer goods. The
product is placed in the formed cavity and sealed by lidding foil.
The product is removed by pushing it through the foil.
B. an aerosol dispensing device which releases medication into the
mouth of the patient. The medication is breathed deeply into the
lungs, or stays in the mouth or throat.
C. a multi-use glass container with a twist-on lid. It can hold
pharmaceuticals, or any kind of fluids or solids. It can be
opened and closed several times until the contents are used up.
Sometimes a desiccant is integrated into the cap so that the
contents remain dry.
D. a small disposable bag containing an individual dose of the
medicine. It often has a lengthwise perforation which can be torn
open.
281. What type of packaging material is a sachet?
A. Tertiary
B. Primary
C. Secondary
D. Both primary and secondary
E.
282. Which primary packaging would you recommend for nose drops?
A. inhaler

266
B. blister pack
C. sachet
D. bottle
283. Which primary packaging would you recommend for oral tablets?
A. blister pack
B. tube
C. syringe
D. sachet
284. Which primary packaging would you recommend for eye drops?
A. jar
B. blister pack
C. tube
D. bottle
285. To use a blister pack, you ______ it
a) tear
b) push through
c) press
d) twist
286. A patient needs to ______ an inhaler to use it.
A. push through
B. twist
C. tear
D. press

287. Choose the CORRECT matching of packaging material and the


verb used to describe how to use them:
1. a sachet - push through
2. an inhaler - tear
3. a jar - twist
4. a blister pack - press
288. A lot of research is done to make packaging ______ ,i.e. a child
cannot open it alone.
A. childproof
B. elderly-accessible
C. child-accessible
D. childrenproof

267
289. In a ______ container system, a closure must be pushed down
before it can be unscrewed.
A. squeeze-screw
B. peel-push
C. slide
D. push-screw
290. In a push-screw container system, a closure must be ______ before
it can be unscrewed.
A. aligned
B. peeled off
C. squeezed
D. pushed down
291. In a ______ container system, a first layer must be peeled off a
blister before the drug can be pushed through the second layer.
A. push-screw
B. squeeze-screw
C. peel-push
D. slide
292. In a peel-push container system, a first layer must be ______ a
blister before the drug can be pushed through the second layer.
A. aligned off
B. peeled off
C. pushed off
D. squeezed off
293. In a ______ container system, a container with three buttons that
must be aligned in order to slide off the lid.
A. peel-push
B. push-screw
C. slide
D. squeeze-screw
294. In a slide container system, a container with three buttons that must
be ______ in order to slide off the lid.
1. pushed
2. squeezed
3. aligned
4. peeled
5.

268
295. What does it mean by ‘security’
A. Following rules and regulations
B. Freedom from danger or harm
C. Protection from threats, such as attacks or crime.
D. Working as part of a team
E.
296. If a pill has a brightly-coloured _______ a child may mistake it for
a sweet.
A. dosage
B. coating
C. dose
D. coated
E.
297. Choose the word that mean the same as “uncomplicated”
A. sample
B. simple
C. complex
D. complexity
298. Nowadays, RRB is a research-driven, innovative pharmaceutical
______ that develops new drugs, produces them, prepares them for sale,
and markets them worldwide.
A. API
B. PIL
C. enterprise
D. NCE
299. Safety is the _____
A. freedom from danger or harm.
B. same as security
C. All of the above
D. protection from threats, such as attacks or crime.
E.
300. A jar is a multi-use glass container with a twist-on lid. Sometimes
a(n) _____ is integrated into the cap so that the contents remain dry.
A. desiccant
B. excipient
C. humidity
D. preservative

269
E.
301. A blister pack is_____
A. A type os single-use plastic container, and is used for
pharmaceutical products as well as for other consumer goods. The
product is placed in the formed cavity and
B. An aerosol dispensing device which releases medication into the
mouth of the patient. The medication is breathed deeply into the lungs,
or stays in the mouth or
C. A multi-use glass container with a twist-on lid. It can hold
pharmaceuticals, or any kind of fluids or solids. It can be opened and
close several times until the
D. A small disposable bag containing an individual dose of the medicine.
It often has a lengthwise perforation which can be torn open
302. Which primary packaging would you recommend for liniment?
A. Inhaler
B. Sachet
C. Tube
D. Blister pack
303. What type of packaging material is a sticky label?
A. Both primary and secondary
B. Primary
C. Secondary
D. Tertiary
304. Well, we have to make sure that there are no mix-up to material
throughout the whole manufacturing process. “mix-up” means:
A. Combine
B. Mistake
C. Conduct
D. Contact
305. The boy’s death highlighted a problem that no one could_____up
to that time
A. Discard
B. Negligence
C. Demand
D. Anticipate
306. The granulator are air-dried in the____
A. Sieve

270
B. Granulator
C. Fluid bed dryer@
D. Drum
307. In the _____. The dried granulator are stamped into a mould to
form tablets
A. Fluid bed
B. Sieve
C. Tablet press
D. Granulator
308. The pressed tablets are held in a_____intil it is time to coat them
A. Granulator
B. Drum
C. Sieve
D. Hoist
309. The____is removed by the hot air in the fluid bed dryer
A. Powder
B. Tablet
C. Granule
D. Moisture@
310. The wet ranules are pressed through a _____on their way to the
fluid bed dryer
A. Granulator
B. Hoist
C. Dispenser
D. Sieve
311. The MHRA is___________
A. An executive agency of the U.S.Department of Health and Human
Services which is responsible for ensuring that medicines and
medical devices work and are acceptably safe.
B. An executive agency of the Department of Health in the European
Union which is responsible for ensuring that medicines and
medical devices work and are acceptably safe.
C. An executive agency of the Department of Health in the United
States which is responsuble for ensuring that medicines and
medical devices work and are acceptably safe.

271
D. An executive agency of the Department of Health in the United
Kingdom which is responsible for ensuring that medicines and
medical devices work and are acceptably safe.
312. _______are inactive substances that serves as the vehicle or
medium for a drug or other active substance
A. API
B. Counterfeit ingredients
C. Excipients
D. PIL
313. We haven’t learnt much as the test results were________
A. Conclusive
B. Definitive
C. Inconclusive
D. Clear
314. The Drug Safety department is responsible for:
A. Monitoring and evaluating suspected side effects.
B. Compiling dossiers for submission to authorities.
C. Submitting documents needed to obtain marketing approval for a
drug.
D. Writing the drug information for the patient.
315. The patient experienced________ and fainting.
A. Dizziness
B. Doziness
C. Dizzy
D. Dossier
316. The ________ is a federal agency within the U.S. Department of
Health and Human Services. It is responsible for ensuring that food,
drugs, and certain other products and processes are safe for consumers.
A. EMEA
B. QPPV
C. MHRA
D. FDA
317. _______ is when blood pressure is higher than normal ( e.g.A
blood pressure of 150/100)
A. Hypoglycemia
B. Hypotension
C. Hyperglycemia

272
D. Hypertension
318. Choose the word that has the same meaning as “low blood
pressure”
A. Hypotension
B. Hypoglycemia
C. Hyperglycemia
D. Hypertension
319. Choose the word that has the same meaning as “ heart racing”
A. Inflammation
B. Irritation
C. Insomnia
D. Palpitation
320. The Drug safety department is NOT responsible for:
A. Reporting an adverse drug reaction to health authorities.
B. Writing the drug information for the patient.
C. Monitoring and evaluating suspected side effects.
D. Responding to a physician’s report about adverse drug reactions.
321. The patient’s normal_________( pulse, blood pressure, respiratory
rate and temperature) were established before the surgery.
A. Vital symptoms
B. Vital signs
C. Vital effects
D. Vital affects
322. The patient_______ the following medication: Mimifem oral
contraceptive pill 0.2 mg daily.
A. Was at
B. Was in
C. Was on
D. Was of
323. Do not take this medicine if you are _____ to any antibiotics.
A. Allergy
B. Allergic
C. Allergen
D. Allergies
324. After examining the patient, the ______ reduced the dosage to 10
mg per day.
A. Attending physical

273
B. Attending physic
C. Attend physician
D. Attending physician
325. Ms Gallois, the well-know opera singer, lost _______ 30 minutes
before she had planned to go on stage.(= the condition of being awake
and able to understand what is happending around you)
A. Unconsciousness
B. Consciousness
C. Unconscious
D. Conscious
326. As to her_______ state after hospital admission, the patient showed
side effects of hyperactivity, accompanied by confusion and a feeling of
agitation.
A. Physician
B. Emotional
C. Omotion
D. Physical
327. The patient has a______ of hypertension, mild heart palpitations,
high adrenalin levels, and often suffers from insomnia
A. Historic
B. History
C. Historical
D. Historian
328. If you_______, you lose consciousness for a short time, especially
because you are hungry, or because of pain, heat or shock.
A. Faint
B. Palpitations
C. Irritation
D. Thirsty
329. Symptoms are__________ of Mensamint, although a correlation
between the patient’s peanut allergy. Mensamint and this event cannot be
ruled out
A. Suspected side reactions
B. Suspected side effects
C. Suspected side actions
D. Suspected side affects
330. Choose the phrase that has the same meaning as “palpitation”

274
A.
high blood pressure
B.
low blood pressure
C.
sleeplessness
D.
heart racing
331. A report received from the patient’s sister that she had_____ of
hypertension
A. experienced
B. reduced
C. recovered
D. a history
332. The FDA is____
A. a state agency within the U.S. Department of Health and Human
Services. It is responsible for ensuring that food, drugs, and certain
other products and processes are safe for consumers
B. a federal agency within the U.S. Department of Health and Human
Services. It is responsible for ensuring that food, drugs, and certain
other products and processes are safe for consumers
C. an executive agency of the Department of Health in the European
Union which is responsible for ensuring that medicines and
medical devices work and are acceptably safe
D. an executive agency of the Department of Health in the United
Kingdom which is responsible for ensuring that medicines and
medical devices work and are acceptably safe
333.

__________ means quick to detect or respond to slight changes, or influences.


e.g. Dogs are more __________ to drugs than mini-pigs.

Sensitive

is the first phase in which patients with the target disease or disorder take part.

Phase II

Phase IV Trials: They are carried out in order to ____ further information about
the drug's safety, efficacy, and optimal use

Gather

_________ are semi-solid emulsion, that is mixtures of oil and water.


275
Creams

Phase II is the first phase in which patients with the target disease or ______
take part.

disorder

Extensive documentation must be provided to the _______ regulatory


authorities.

appropriate

Phase III is the final phase before getting ______.

Marketing approval

__________ means 'for a short time' . e.g. The trial director spoke __________
to his staff about the current status of the trial.

Briefly

The parents took the authority to _____ after their daughter had died of cancer.

Court

Drug __________ describes the chemical reactions catalysed by enzymes that


change drugs into compounds which are easier to eliminate.

Metabolism

Phase I Trials: These are studies which are performed to evaluate the safety of
drugs in ______ people, and to determine the pharmacological properties of
drugs.

Healthy

Clinical trials are mainly aimed at answering scientific questions. In general,


their goal is to gather statistics to determine whether an ______ is safe and
effective.

Experimental drug

_________ is the result of a change. e.g. I felt the __________ of the new
ointment right away.

effect
276
Drug __________ is the movement of drugs throughout the body after
absorption.
Distribution
An adverse event is any _____ medical oc1currence in a patient or clinical trial
subject after a medicinal product has been administered .

Abnormal

Subjects in a trial must be willing to be _______ assigned to either the group


which receives the unapproved medication or the one which gets a placebo

Randomly

Drug __________ is the removal of a drug or its metabolites from the body.

Excretion

In __________, a large group of patients is studied and closely monitored by


physicians for efficacy and any adverse events after long-term exposure to the
drug.

Phase III

An adverse event is any abnormal medical occurrence in a patient or clinical


trial subject after a ________ product has been administered.

Medicinal

The general health of the dogs was regularly checked. On Day 2, abnormalities
regarding food ______ were observed shortly after administration in the high-
dosegroup.

Consumption

Phase I Trials: These are studies which are performed to ____ the safety of
drugs in healthy people and to determine the pharmacological properties of
drugs.

Evaluate

____________ refer to the testing of an investigational drug, a procedure, or


another medical treatment in the laboratory to ensure it will be safe to
administer to humans. (also called preclinical development)

277
Preclinical studies

Many terminally ill people fall victim to the therapeutic _______ that the
objective of trials is to cure them.
Misconception
__________(s) regarding food consumption were observed shortly after
administration in the high- dose group.

Abnormality

_________ means "in cells in a test tube"

In vitro

The active ingredient currently being tested seems to ______the kidneys.


Affect
Adverse reaction refers to all abnormal and unintended _____to an
investigational medicinal product related to any dose administered.

Response

The dogs started retching and vomiting and were separated to allow closer
______.

Observation

Miki has been invited to join an ______ lab meeting about drug substance MPP
010098, which is being tested in dogs. ( = without planning or organizing it in
advance.)

Impromptu

__________ is the final phase before getting marketing approval.

Phase III

Regulatory agencies require testing that documents the characteristics -chemical


composition,purity quality,and _______ -of thedrug's active ingredient,and of
the formulated drug.
Potency
_________ means practical and reasonable. e.g. It was a __________ decision
to cancel the trial.

278
Sensible

The safety and efficacy of a drug can only be determined by conducting _____
clinical trials, according to the FDA.
Rigorous

Do terminally ill patients have the ______ to try to prolong their lives by taking
experimental drugs?
Legal right

__________ are semi-solid emulsion, that is mixtures of oil and water.

Phase 4

Phase II Trials: These are controlled studies conducted to evaluate the


effectiveness of the drug in a particular _______ and to determine possible side
effects and risks
Indication

A _______ in preclinical studies is a group of test animals that is not exposed to


the medication under study. In an experiment, this group is treated just like the
other animals, but does not receive the active ingredient. This group is then
compared with the treated animals in order to validate the results of the test.

Control group

The parents of a 21-year-old woman challenged the FDA.They took the


_______ to court after their daughter had died of cancer.

Authority

Low-dose/mid-dose/high-dose groups are three groups of animals which receive


different _______(s) of the medication understudy.

Concentration

Phase II is performed after there is preliminary _____ that the drug is effective.
Evidence

__________ is performed to evaluate the safety of drugs in healthy people, and


to determine the pharmacological properties of drugs

Phase I

279
Toxicology ís the study of the _______risks to the body.

Potential

The results of all testing must be provided to the FDA in the United States
and/or other appropriate regulatory agencies in other countries in order to ____
permission to begin clinical testing in humans.

Obtain

The active ingredient can be tested in humans only after these tests have been
successfully completed and _______ has been given.

Authorization

__________ is performed after there is preliminary evidence that the drug is


effective to obtain additional information to evaluate the overall benefit-risk
relationship of the drug.

Phase III

A drug that is intended to______ the sinuses may be formulated as a time-


release capsule, or as a nasal spray.

Act on

In phase__________ , further information regarding drug's safety, efficacy, and


the ideal(optimal) use of the drug is collected.
Phase 4

The safety and ______ of a drug can only be determined by conducting rigorous
clinical trials, according to the FDA.

Efficacy

In the preclinical stage of drug development, a(n) ______ must be tested


extensively in the laboratory. This is to ensure it will be safe to administer to
humans.
Investigational drug

The general health and ______ of the dogs were checked twice a day.

Behaviour

280
A __________ assists chemists and chemical engineers using chemicals and
related products
Chemistry lab technician

In __________ the drug reacts in the body, toxicity, metabolism, absorption,


and excretion are observed and documented.

Phase I

_________ means 'soon'. e.g. The adverse event occurred shortly after the
injection.

Shortly

__________ is used to describe a person who is in a poor state of health. e.g. He


missed five days of work because of _________.

Illness

In addition, the overall ______ and behaviour of each animal was assessed
twice a day

Appearance

________ is the post-marketing study after getting approval for general sale.

Phase 4

Test subjects in the treatment group receive the medication under study,
whereas the control group receives either a standard medication or a _____.
Placebo

Regulatory agencies have to give permission to ______ with the clinical testing
in humans, which is also done at our company.

Commence

Drug __________ is the movement of a drug from its site of administration into
the blood.

Absorption

281
An __________ is any abnormal medical occurrence in a patient or clinical trial
subject after a medicinal product has been administered. It does not necessarily
have a causal relationship with the medicinal product.

Adverse event

During the preclinical developmentof a drug,laboratory tests document the


effect of the investigational drug in living ______,and in cells in a test tube (in
vitro).

Organism

__________ means "in living organisms"

In vivo

Phase III Trials: A large group of patients is studied and closely monitored by
physicians for efficacy and any adverse events after long-term ____ to the drug.

Exposure

Phase IITrials are controlled studies conducted to evaluate the ______ of the
drug in a particular indication and to determine possible side effects and risks.
Effectiveness

A __________ works with living organisms.


Biology lab technician

Many terminally ill people _____ the 'therapeutic misconception that the
objective of trials is to cure them.

Fall victim to

Phase II Trials: These are controlled studies conducted to evaluate the


effectiveness of the drug in a particular _______ and to determine possible side
effects and risks

Indication

_______ stands for Chemistry, Manufacturing and Controls. It is a part of new


pharmaceutical product application to the US Food and Drug Administration.
CMC

282
Phase II Trials are controlled studies conducted to evaluate the ______ of the
drug in a particular indication and to determine possible side effects and risks.

Effectiveness

In phase _________, testings are done to determine the safety and efficacy of
the drug in treating the condition and establishes the minimum and maximum
effective dose.

Phase II

The products of drug metabolism are called _____.

Metabolites

An adverse event is any _____ medical occurrence in a patient or clinical trial


subject after a medicinal product has been administered .

Abnormal

Phase II clinical trial is performed after there is _____evidence that the drug is
effective.

Preliminary

An adverse event is any abnormal medical occurrence in a patient or clinical


trial subject after a medicinal product has been administered. It does not
necessarily have a ______ with the medicinal product

Control group

A __________ is an abnormal condition that affects the body of an organism,


often caused by pathogens. e.g. There is a history of lung __________ in the
family.

Disease

After gaining evidence that the drug is effective, these controlled and
uncontrolled trials are carried out to obtain additional information to evaluate
the overall ______ relationship of the drug.

Benefit risk

The evidence is inconclusive.The facts neither prove nor ____ this.

283
Disprove

In order to get approval to sell a new drug, a company has to _____ detailed
documentation with all the information required by the drug authorities

Compile

It has the same packaging, same colour coating, same bitter _______, but not
the same ingredients inside the pill. Is this a fake drug?

Aftertaste

__________ department is responsible for compilWith the _______ of online


pharmacies, open borders and uncontrolled chemical laboratories all
oveing dossiers for submission to authorities, submitting documents needed to
obtain marketing approval for a drug, and writing the drug information for the
patient.

Regulatory. Affairs

When describing possible side effects for products in the pipeline, we will need
to differentiate more clearly between _____ and rare risks

Frequent

The patient was ______ taking the following medication:Mimifem oral


contraceptive pill and Mensamint.

Concomitantly

At the hospital, the patient showed evidence of hyperactivity, accompanied by


______ and agitation.

Confusion

Do not take Penicillin if you are allergic to any ______(s).

Antibiotic

____ is an inactive substance that serves as the vehicle or medium for a drug or
other active substance.

Excipient

284
In Europe, steps have been taken to use holograms to prove a pharmacopeias
______.
Authenticity

Symptoms of __________ include: red, warm, and swollen.

Inflammation

Government agencies, pharmaceutical companies ,and healthcare professionals


work together to _____and evaluate suspected side effects of medicines to
improve the safety of drugs in use

Monitor

If you have a history of heart trouble, ______ your doctor before taking this
medicine.

Consult

_____ is a drug or method used to prevent a woman from becoming pregnant


when she has sex.

Contraceptive

Someone has a ___________, that person has a lot of spots on the skin.

Rash

Iris Berger from HR will place job ads in several major pharmaceutical journals
to look for two new clinical research associates to ______ the trials in the test
centres in France.
Conduct

The ________ is an executive agency of the Department of Health in the United


Kingdom which is responsible for ensuring that medicines and medical devices
work and are acceptably safe.
MHRA

If you ______, you lose consciousness for a short time, especially because you
are hungry, or because of pain, heat, or shock.
Faint

285
PHARMACOVIGILANCE - Government agencies, pharmaceutical companies,
and __________ work together to monitor and evaluate suspected side effects
of medicines to improve the safety of drugs in use.

Healthcare professionals

Serious adverse event (SAE) - an adverse event that threatens life, requires or
prolongs _______, or results in death.

Hospitalization

In rare cases, CAREFREEDO may cause the following side effects: ______
blood pressure, dizziness, allergic reactions...

Elevated

Regulatory Affairs department is responsible for compiling the ________ for


submission to drug regulatory authorities.

Dossier

The patient's normal __________ (pulse, blood pressure, respiratory rate and
temperature) are established in the pre-operative period and variations 10%
above or below the pre-operative measurement should be reported immediately.

Vital signs

_________ stands for Qualified Person Responsible for Pharmacovigilance.

QPPV

The 'Possible side effects' section of a Patient Information leaflet categorizes


known side effects according to their ______.
Frequency

____ is a fine powder produced by flowers, which is carried by the wind or by


insects to other flowers of the same type, making them produce seeds.
Pollen

_________ is an unwanted medical occurrence which a patient experiences


during treatment. This may or may not be a side effect of a drug.

Adverse event

286
At the hospital, the patient showed evidence of hyperactivity , accompanied by
confusion and _______.

Agitation

Do not take Mensamint TM if you are _______ to peanut.

Allergic

I just wanted to give you a _____ update on the self-inspection conducted last
week by QA

Brief

_________ means patient information leaflets.

PIL’s

When you talk about PILs, say each letter. If not, it might be _____with 'pills'

Confused

_________ Government agencies, pharmaceutical companies, and healthcare


professionals work together to monitor and evaluate suspected side effects of
medicines to improve the safety of drugs in use.

Pharmacovigilance

____ is a drug used to make someone calm or go to sleep.

Sedative

Abdominal pain is the pain in your stomach or ______.

Intestines

After 24 hours, all symptoms except for a mild skin irritation had subsided and
the patient was_____(ed) from hospital.

Discharge

Mensamint is a lozenge to support increased concentration. The active


substance is mensagitatum. Other ingredients are peppermint, oil, sugar, talcum,
and ______.

Preservative

287
_____ side effects of CAREFREEDO are: nausea, vomiting, abdominal pain
(pain in your stomach or intestines)

Common

Important information for any person taking a drug can be found in the
_________.

Patient information leaflet

Fake drug may have the same packaging, same colour _______, same bitter
aftertaste, but not the same ingredients inside the pill.

Coating

_________ (SAE) is an adverse event that threatens life, requires or prolongs


hospitalization, or results in death.

Serious adverse event

You investigate the adverse event by looking for similar side effects in the
documentation and report it to the authorities. Still, nothing even vaguely
similar can be found for either the ______(API) or any of the excipients.

Active pharmaceutical ingredient

The __________ is the Food and Drug Administration (US) It is responsible for
ensuring that food, drugs, and certain other products and processes are safe for
consumers.

FDA

A ______ person or a _______ event attracts a lot of attention or publicity. (=


famous)

High profile

The patient has a ______ of hypertension, mild heart palpitations, high


adrenalin levels,and often suffers from insomnia.

History

With the _______ of online pharmacies, open borders and uncontrolled


chemical laboratories all over the world, the number of counterfeit drugs is on
the rise, not only in developing but also in industrialized countries.
288
Advent

_________ is when blood pressure is higher than normal (e.g. A blood pressure
of 140/90)

Hypertension

hypertension means high _______.

Blood pressure

At the hospital, the patient showed evidence of hyperactivity , _______ by


confusion and agitation.

Accompanied

Pharmaceutical companies use details from doctors' reports to inform the


authorities in a ______.

Case report

_____ means the specialized language used by people in the same work/
profession or industry.

Jargon

_______ is when you feel like you want to scratch.

Itching

A _______ between Mensamint and the symptoms cannot be ruled out.


Correlation

When describing possible side effects for products in the pipeline, we will need
to ______more clearly between frequent and rare risks.

Differentiate

A _____ accident or illness causes someone's death.


Fatal

We do need to let patients know of any possible side effects. But, it is


not necessary to _____them unnecessarily.

Alarm

289
Keep _________ of children.

Out of reach

The number of counterfeit drugs is on the rise, not only in developing but
also in ______ country

Industrialized

Better styling in the PIL could increase______.

Patient compliance

The ___________ is a European Union agency for the evaluation of medicinal


products.
EMEA

___ drugs may contain: a worthless placebo; a lower concentration of


the same active ingredient; a similar, but different substance; a totally
different, potentially dangerous substance.

Counterfeit hoặc chọn fake (ưu tiên )

If you feel _______, you feel that you are losing your balance and are about to
fall.
Dizzy
The patient has an _____ to peanuts.
Allergy
_______ is when you feel like you want to scratch.
Itching
The __________ of Mensamint TM is mensagitatum. Other ingredients
are peppermint, oil, sugar, talcum, and a preservative.

Active substance

At the hospital, the patient showed evidence of hyperactivity , _______


by confusion and agitation.

Accompanied

___ pain is the pain in your stomach or intestines.

290
Abdominal

_____ more international co-operation in the fight to stop counterfeit


drugs, some countries have unfortunately not taken action.

Despite

Keep out of ______ of children.

Reach

_______ is any unintended reaction caused by a drug or medical


treatment. This term is used by the general public, but is often avoided
by medical authorities.

Side effect

Our patients shouldn't be so alarmed that they are afraid to actually put the pills
in their mouth and swallow them. The PIL just needs to reflect the _______ of
side effects.
Probability

________ means general discomfort, bad feeling.

Irritation

When describing possible side effects for products in the pipeline, we


will need to ______more clearly between frequent and rare risks.

Differentiate

is a seasonal allergy to pollens.

Hay fever

As to her _____state after hospital admission,the patient showed side


effects of hyperactivity, accompanied by confusion and a feeling of
agitation.

Emotional

____ is an official document issued by the drug regulatory authority for


the purpose of marketing or free distribution of a product after evaluation
for safety, efficacy and quality.

291
Marketing authorization

________ is an official publication containing a list of medicinal drugs


with their effects and directions for their use.

Pharmacopeia

Important information for any person taking a drug can be found in the
'PIL'or patient information _____.
Leaflet

___ is a seasonal allergy to pollens.

Hay fever

The number of counterfeit drugs is on the rise, not only in developing but also
in ______ country
Industrialized

__________ is when blood pressure is lower than normal (e.g. A blood


pressure of 65/70).
Hypotension

Mensamint may cause _______.(a sensation of spinning around and losing one's
balance)
Dizziness

________ department is responsible for monitoring and evaluating


suspected side effects, reporting an adverse drug reaction to health
authorities, and responding to a physician's report.
Drug safety

Although the evidence is _______, a reaction to Mensamint cannot be


completely ruled out

Inconclusive

As to her emotional state after ________, the patient showed evidence


of hyperactivity, accompanied by confusion and a feeling of agitation.

Hospital admission

292
After examining the patient, the _______ reduced the dosage to 10 mg
per day .

Attending physician

Ms Gallois, the well-known opera singer, lost _______ 30 minutes


before she had planned to go on stage. ( = the condition of being awake
and able to understand what is happening around you)

Consciousness

________ stands for (active pharmaceutical ingredient)

API

Adverse event is an unwanted medical occurrence which a patient


_____(s) during treatment. This may or may not be a side effect of a
drug.

Experience

______ department is responsible for compiling dossiers for submission


to authorities, submitting documents needed to obtain marketing
approval for a drug, and writing the drug information for the patient.

Regulatory affairs

______ protect hands from chemical compounds


Rubber gloves

In order to receive valid and _____ results, all devices and methods
have to undergo a validation process.
Reliable

A four year old boy was found dead after he had stuck a highly potent, ______
patch to his leg.
Pain relieving

Which primary packaging is the most suitable for nose drops?


Bottle

293
A(n) __________ is a piece of paper attached with adhesive to the
primary packaging to identify it and give details concerning its
ownership, nature, and/or use.

Sticky label

A _____ must be worn at all times in this area to protect your head.

Hard hat

In the _________, As the tablets go up a spiral, they are shaken, and


the excess powder is vacuumed off. The pressed tablets are put into a
drum and stored until it is time to coat them.

Excess powder remover

A jar is a multi-use glass container with a twist-on lid. It can hold


pharmaceuticals, or any kind of fluids or solids. It can be opened and
closed several times until the ______(s) are used up. Sometimes a
desiccant is integrated into the cap so that the _______(s) remain dry.

Content

A(n) __________ is an aerosol dispensing device which releases


medication into the mouth of the patient. The medication is breathed
deeply into the lungs, or stays in the mouth or throat.
Inhaler

Well, we have to make sure that there are no ______(s) (mistake) of


materials throughout the whole manufacturing process.

Mix up

A(n) __________ is a small disposable bag containing an individual


dose of the medicine. It often has a lengthwise perforation which can be
torn open.

Sachet

A mother was sentenced to several years' ________ for leaving a used


medical patch in a place where her young son could have access to it.

Community service

294
The elderly must have easy access to their medication,i.e.it needs to be
_________

Elderly accessible

In the _________, the ingredients are mixed to create a wet mixture.


Granulator

A __________ system sucks up the excess powder.

Vacuum

Pharmaceutical companies have to comply with GMP ____.

Guidelines

________is the protection from threats, such as attacks or crime.

Security

Slide container system is a container with three buttons that must be


____(ed) in order to slide off the lid .

Align

If you give instructions in a very direct way, it may not sound _____.

Polite

Nowadays, RRB is a research-driven,innovative pharmaceutical ___ that


develops new drugs, produces them, prepares them for sale, and markets them
worldwide.
Enterprise

_______ is the freedom from danger or harm.

Safety

A drum holds the pressed tablets until it is time to ______ them

Coat

___ is a machine/ mechanism which releases its contents in defined amounts.


Dispenser

____ is a place where company has its offices and/ or factories.


295
Premises

A(n) __________ is a multi-use glass container with a twist-on lid. It can


hold pharmaceuticals, or any kind of fluids or solids. It can be opened
and closed several times until the contents are used up. Sometimes a
desiccant is integrated into the cap so that the contents remain dry.

Jar

Which primary packaging is the most suitable for ointments?


Tube

_______ tablets are uncoated tablets containing substances that react in


the presence of water and give off carbon dioxide.

Effervescent

A closure must be pushed down before it can be unscrewed.

Push screw (Container system )

________ is the amount of water vapor in the air

Humidity

Lab equipment should always be clean or sterile and ______(d) before


using it.

Calibrate

A few years ago, a mother was convicted of negligence leading to her son's
death. It was claimed that he had died from a pain medication _____.
Overdose

A closure must be squeezed between two fingers before it can be


unscrewed.

Squeeze screw (Container system )

The dried granules are stamped into a mould to form tablets in the __________.
Tablet press

A first layer must be peeled off a blister before the drug can be pushed
through the second layer.

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Peel push system

The ______ is removed by the hot air in the fluid bed dryer.

Moisture

The granules are air-dried in the __________.


Fluid bed dryer

A __________ holds the pressed tablets until it is time to coat them.

Drum

GMP covers how to design and construct buildings so that the flow of
materials is ______(ed), and so that they can be cleaned easily.

Optimize

A sachet is a small ______ bag containing an individual dose of the


medicine. It often has a lengthwise perforation which can be torn open.

Disposable

A jar is a multi-use glass container with a twist-on lid. It can hold


pharmaceuticals, or any kind of fluids or solids. It can be opened and
closed several times until the contents are used up. Sometimes a
desiccant is integrated into the ______ so that the contents remain dry.

Cap

A sachet is a small disposable bag containing a(n) ______ dose of the


medicine. It often has a lengthwise perforation which can be torn open.

Individual

A tube that can only be released by an adult-length finger by pushing an internal


______.
Catch

The wet granules are pressed through a _________ on their way to the
fluid bed dryer.

Sieve

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________ protects the scientist and the scientist's clothes from
hazardous or hot chemicals

Lab coat

A __________ loosens the excess powder.

Shaker

Safe-disposal boxes should be included in the packages of medicated


patches. These boxes should have a small slit at the top to _____ used
patches and it should be impossible to open them.

Discard

A jar is a multi-use glass container with a twist-on lid. It can hold


pharmaceuticals, or any kind of fluids or solids. It can be opened and
closed several times until the contents are used up. Sometimes a _____
is integrated into the cap so that the contents remain dry.

Desiccant

The dried granules are stamped into a _____ to form tablets.

Mould

A(n) __________ is a type of single-use plastic container, and is used


for pharmaceutical products as well as for other consumer goods. The
product is placed in the formed cavity and sealed by lidding foil. The
product is removed by pushing it through the foil.

Blister pack

________ are used to protect your eyes are you work in the lab such as
chemical splashes/spills.
Safety goggles

Because of her son's death, the young mother _____(ed) that safe-
disposal boxes be included in the packages of medicated patches.

Demand

The dried ____(s) are stamped into a mould to form tablets.


Granule

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During the manufacturing process, technicians also check the samples
for content _______, content weight, and so on.
Uniformity

A blister pack is a type of single-use plastic container, and is used for


pharmaceutical products as well as for other consumer goods. The
product is placed in the formed cavity and sealed by lidding ______. The
product is removed by pushing it through the ____.

Foil

A few years ago, a mother was convicted of _______ leading to her


son's death. ( = Failure to take proper care over something/someone)

Negligence

________ is any packaging material that is not in direct contact With the
product.

Secondary packaging

During the manufacturing process, technicians also check the samples for
content uniformity, ______, and so on.
Content weight

A lot of research is done to make packaging childproof,i.e. a child cannot


open it alone. However, at the same time, the elderly must have easy
access to their medication,i.e.it needs to be elderly-_______.

Accessible

Please mind the _____ substances, which could cause severe burns.

Corrosive

If someone is ______(d) of a crime, they are found guilty of that crime in


a law court.
Convict

A tube that can only be released by an adult-length finger by pushing an


internal catch.

Poke (container system )

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A(n) __________ is a needle attached to a plastic tube used for putting
medicine into the body or removing blood.
Syringe

Pharmaceutical companies have to ______ GMP guidelines

Comply with

________ means a child cannot open it alone.


Childproof

Dry ingredients are weighed and transported to the granulator by the


_______

Hoist

A container with three buttons that must be aligned in order to slide off
the lid.

Slide (container. System )

______ is the material which is in direct contact with the product.

Primary packaging

In a "push-screw" container system, a _______ must be pushed down


before it can be unscrewed.

Closure

The boy's death highlighted a problem that no one had _______(d) up to


that time .

Anticipate

AVCN2_Pharmaceutical Industry Unit 4


1. Drug __________ is the movement of a drug from its site of
administration into the blood.

a) Excretion b) Absorption

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c) Metabolism d) Distribution

2. Drug __________ is the movement of a drug from its site of


administration into the blood.

a) Adsorption b) Absorption

c) Admission d) Administration

3. Drug __________ describes the chemical reactions catalysed by


enzymes that change drugs into compounds which are easier to eliminate.

a) Absorption b) Distribution

c) Metabolism d) Excretion

4. Drug metabolism describes the chemical reactions catalysed by


enzymes that change drugs into compounds which are easier to _______ .

a) eliminate b) adsorb

c) distribute d) absorb

5. Drug __________ is the movement of drugs throughout the body after


absorption.

a) Metabolism b) Absorption

c) Distribution d) Excretion

6. Drug distribution is the movement of drugs throughout the body after


________.

a) Metabolism b) Absorption

c) Elimination d) Adsorption

7. Adverse reaction refers to all abnormal and unintended responses to


an investigational medicinal product. It is _______

a) unaffected by the dose administered.

b) related to the dose administered.

c) independent of the dose administered


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d) not related to the dose administered.

8. An __________ is any abnormal medical occurrence in a patient or


clinical trial subject after a medicinal product has been administered. It
does not necessarily have a causal relationship with the medicinal product.

a) Adverse reaction b) Adverse effect

c) Side effect d) Adverse event

9. Side effect is any unintended reaction caused by a drug or


medicaltreatment. This term ______

a) is the same as serious adverse reaction.

b) is used by the general public, but is often avoided by doctors.

c) is used by the general public and the medical authorities.

d) is used by the general public, but is often avoided by medical


authorities.

10. The active ingredient currently being tested seems to __________ the
kidneys.

a) Effect b) Affect

c) Effective d) Affection

11. A __________ assists chemists and chemical engineers using chemicals


and related products

a) Clinical affair associate b) Biology lab technician

c) Chemistry lab technician d) Lab technician

12. A _________ works with living organisms.

a) Chemistry lab technician b) Lab technician

c) Clinical affair associate d) Biology lab technician

13. A __________ in preclinical studies is a group of test animals that is


not exposed to the medication under study.

a) Study group b) Treatment group

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c) Control group d) Research group

14. A control group in preclinical studies is a group of test animals that is


_______

a) not exposed to the placebo under study.

b) not exposed to the medication under study.

c) exposed to the medication under study.

d) exposed to the active pharmaceutical ingredient (API) under study.

15. _______studies that are conducted on whole, living organisms, usually


animals, including humans, and plants as opposed to a partial or dead
organism.

a) in vivo b) test-tube

c) in vitro d) clinical

16. In vivo studies that are conducted on _______

a) cells b) dead organisms

c) biological molecules d) living organisms

17. During the preclinical _______ of a drug, laboratory tests document


the effect of the investigational drug in living organisms (in vivo), and in
cells in a test tube (in vitro)

a) deployment b) formulation

c) trial d) development

18. The results of preclinical testing are used by experts in


pharmaceutical methods to determine how to best ________ the drug for its
intended clinical use

a) formulate b) administer

c) development d) test

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19. The results of all testing must be provided to the _______ in the
United States and/or other appropriate regulatory agencies in other
countries in order to obtain permission to begin clinical testing in humans.

a) FDA b) MHRA

c) CMC d) QPPV

20. The results of all testing must be provided to the _______ in the
United Kingdom and/or other appropriate regulatory agencies in other
countries in order to obtain permission to begin clinical testing in humans.

a) MHRA b) QPPV

c) FDA d) CMC

21. First of all, it is the _____ of the company to complete the preclinical
trials by the end of the year.

a) intention b) instruction

c) intend d) intent

22. Regulatory agencies have to give ______ before clinical testing can be
conducted in humans.

a) information b) permission

c) inform d) permit

23. Extensive documentation must ______ to the appropriate regulatory


authorities.

a) be used b) be determined

c) be provided d) be conducted

24. A drug intended to act on the skin can ______ as a cream.

a) formulated b) be used

c) be formulated d) formulate

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25. The requirements of drug _______determine how it will be
administered to humans.

a) biography b) biomedical

c) bioavailability d) biology

26. Could somebody please fill me______ what the problem is ?

a) in on b) on

c) in d) up

27. ________ trials are studies which are performed to evaluate the safety
of

drugs in healthy people, and to determine the pharmacological properties


of drugs

a) Phase II b) Phase III

c) Phase I d) Phase IV

28. _______ trials are controlled studies conducted to evaluate the


effectiveness of the drug in a particular indication and to determine
possible side effects and risks. In this phase, testing determines the safety
and efficacy of the drug in treating the condition and establishes the
minimum and maximum effective dose.

a) Phase II b) Phase IV

c) Phase I d) Phase III

29. ______ is performed after there is preliminary evidence that the drug
is effective.

a) Phase I b) Phase IV

c) Phase II d) Phase III

30. _______ is the first phase in which patients with the target disease or
disorder take part.

a) Phase II b) Phase IV

c) Phase I d) Phase III


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31. ________ is the final phase before getting marketing approval.

a) Phase IV b) Phase II

c) Phase I d) Phase III

32. Phase IV trials are _______ studies after getting approval for general
sale. They are carried out in order to gather further information about the
drug’s safety, efficacy, and optimal use.

a) post-research b) post-marketing

c) post-development d) pre-marketing

33. Phase I trials are studies which are performed to evaluate the safety of
drugs in _______, and to determine the pharmacological properties of
drugs

a) large group of patients b) volunteers and a number of patients

c) healthy people d) small group of patients

34. Dogs are more ______ to drugs than mini-pigs

a) effective b) sensible

c) affected d) sensitive

35. Choose the INCORRECT statement about clinical trials:

a) Subjects in a trial are randomly assigned to either the group which receives
the unapproved medication or the one which gets a placebo.

b) Clinical trials are aimed at gathering statistics to determine whether an


experimental drug is safe and effective.

c) Clinical trials are mainly aimed at providing medication to terminal ill


patients.

d) Pharmaceutical company which is sponsoring the clinical trial can stop the
trial any time.

36. Participating in clinical trials is a good way to _______ some extra


money

a) win b) become
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c) earn d) keep

37. The overall _______ of the drug must be evaluated

a) profit-risk b) benefit-risk

c) deficit-risk d) cost-risk

38. A control group receives either standard medication or a ______

a) placenta b) platelet

c) placebo d) plasma

39. An inert tablet is called______

a) platelet b) placenta

c) plasma d) placebo

40. An adverse event is any _____ medical occurrence in a patient or


clinical trial subject after a medicinal product has been administered .

a) abnormal b) abnormally

c) abdominal d) abnormality

41. In the preclinical stage of drug development, an investigational drug


must be tested extensively in the laboratory. This is to ensure it will be safe
to _____to humans.

a) admit b) administer

c) admission d) admin

42. The results of all testing must be provided to the FDA in the United
States and/or other appropriate regulatory agencies in other countries in
order to obtain permission to begin ______ testing in humans.

a) critical b) non-clinical

c) clinic d) clinical

43. In the preclinical stage of drug development, a(n) ______ must be


tested extensively in the laboratory. This is to ensure it will be safe to
administer to humans.

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a) investigation placebo b) investigational drug

c) investigation drug d) investigational placebo

44. Regulatory agencies require testing that documents the characteristics


- chemical composition,purity quality,and _______ -of thedrug’s active
ingredient,and of the formulated drug.

a) all of the above b) potent

c) patent d) potency

45. Regulatory agencies have to give permission to ______ with the


clinical testing in humans.

a) commerce b) comment

c) commence d) command

46. First of all, it is the _______ of the company to complete the


preclinical trials by the end of the year.

a) intention b) all of the above

c) goal d) aim

47. Low-dose/mid-dose/high-dose groups are three groups of animals


which receive different _______(s) of the medication understudy.

a) concentrate b) concentration

c) concentrated d) condensation

48. A _______ in preclinical studies is a group of test animals that is not


exposed to the medication under study. In an experiment, this group is
treated just like the other animals, but does not receive the active
ingredient.

a) control group b) study group

c) uncontrolled group d) research group

49. The general health and ______ of the dogs were checked twice a day.

a) appear b) behaviour

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c) behave d) appeal

50. On Day 2, abnormalities regarding food ______ were observed shortly


after administration in the high-dosegroup.

a) consumer b) consume

c) costumer d) consumption

51. Phase III is performed after there is preliminary evidence that the
drug is effective to obtain additional information to evaluate the overall
______ of the drug.

a) benefit-risk relation b) benefit-risk creation

c) benefit-risk relationship d) benefit-risk reaction

52. Phase II is the first phase in which patients with the target disease or
______ take part.

a) disaster b) discovery

c) discover d) disorder

53. Phase III Trials: A large group of patients is studied and closely
monitored by physicians for efficacy and any adverse events after long-
term ____ to the drug.

a) expose b) express

c) explosive d) exposure

54. Phase IV Trials: They are carried out in order to ____ further
information about the drug’s safety, efficacy, and optimal use.

a) connect b) collect

c) gathering d) A&B are correct

55. Phase II is performed after there is preliminary _____ that the drug is
effective.

a) evidence b) refusal

c) contamination d) contradiction

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56. The safety and efficacy of a drug can only be determined by
conducting _____ clinical trials, according to the FDA.(= very thorough
and strict)

a) rigorous b) easy

c) careless d) imprecise

57. The parents of a 21-year-old woman challenged the FDA.They took


the authority ____ after their daughter had died of cancer.

a) of court b) in court

c) at court d) to court

58. The safety and ______ of a drug can only be determined by conducting
rigorous clinical trials, according to the FDA.

a) effective b) deficiency

c) defectiveness d) efficacy

310
AVCN2_Pharmaceutical Industry Unit 5
1. The Drug Safety department is responsible for:

a) Writing the drug information for the patient.

b)Submitting documents needed to obtain marketing approval for a drug.

c) Compiling dossiers for submission to authorities.

d) Reporting an adverse drug reaction to health authorities.

2. The Regulatory Affairs department is NOT responsible for:

a) Submitting documents needed to obtain marketing approval for a drug.

b) Writing the drug information for the patient.

c) Compiling dossiers for submission to authorities.

d) Reporting an adverse drug reaction to health authorities.

3. The Regulatory Affairs department is NOT responsible for:

a) Writing the drug information for the patient.

b) Responding to a physician’s report about adverse drug reactions.

c) Compiling dossiers for submission to authorities.

d) Submitting documents needed to obtain marketing approval for a drug.

4. The Drug Safety department is responsible for:

a) Compiling dossiers for submission to authorities.

b) Writing the drug information for the patient.

c) Submitting documents needed to obtain marketing approval for a drug


d) Responding to a physician’s report about adverse drug reactions.

5. The Regulatory Affairs department is responsible for:

a) Reporting an adverse drug reaction to health authorities.

b) Responding to a physician’s report about adverse drug reactions.

311
c) Monitoring and evaluating suspected side effects.

d) Compiling dossiers for submission to authorities.

6. The Drug safety department is NOT responsible for:

a) Responding to a physician’s report about adverse drug reactions.

b) Reporting an adverse drug reaction to health authorities.

c) Monitoring and evaluating suspected side effects.

d) Compiling dossiers for submission to authorities.

7. __________ is the practice of monitoring the effects of medical drugs


after they have been licensed for use, especially in order to identify and
evaluate previously unreported adverse reactions.

a) Pharmacology b) Pharmaceutics

c) Pharmacovigilance d) Pharmacokinetics

8. __________ is the practice where government agencies, pharmaceutical


companies, and healthcare professionals work together to monitor and
evaluate suspected side effects of medicines to improve the safety of drugs
in use.

a) Pharmaceutics b) Pharmacovigilance

c) Pharmacokinetics d) Pharmacology

9. ________ is an unwanted medical occurrence which a patient


experiences during treatment. This may or may not be a side effect of a
drug.

a) Adverse event b) Adverse action

c) Adverse even d) Adverse affect

10. ________ is any unintended reaction caused by a drug or medical


treatment. This term is used by the general public, but is often avoided by
medical authorities.

a) Side effect b) Side affect

c) Side action d) Side reaction


312
11. A _________ threatens life, requires or prolongs hospitalization, or
results in death.

a) serious adverse event b) serious adverse action

c) serious adverse affect d) serious side affect

12. Someone has a(n) ___________, that person has a lot of red spots on the
skin.

a) hypertension b) rash

c) palpitation d) insomnia

13. ________is an uncomfortable sensation in the skin that feels as if


something is crawling on the skin and makes the person want to scratch the
affected area.

a) Insomnia b) Itching

c) Inflammation d) Infection

14. __________ means general discomfort, bad feeling.

a) Irritation b) Insomnia

c) Inflammation d) Itching

15. __________ is when blood pressure is lower than normal (e.g. A blood
pressure of 80/60).

a) Hyperglycemia b) Hypoglycemia

c) Hypotension d) Hypertension

16. When someone has a blood pressure of 80/60, that person has
________

a) Hypertension b) Hypotension

c) Hypoglycemia d) Hyperglycemia

313
17. ________ is/are the feelings of having rapid, fluttering or pounding
heart, triggered by stress, exercise, medication or, rarely, a medical
condition.

a) Heart inflammation b) Heartburn

c) Heart irritation d) Heart palpitations

18. Choose the word that has the same meaning as “sleeplessness"

a) irritation b) insomnia

c) inflammation d) itching

19. A report received from the patient’s sister indicated that she had
________ of hypertension.

a) reduced b) a history

c) experienced d) recovered

20. After having taken Mensamint, the patient _______(ed) headaches


and insomnia.

a) recover b) express

c) feel d) experience

21. __________ from a physician indicating that a woman had fainted


after developing a sudden, severe skin rash and inflammation all over her
body.

a) Vital signs b) The patient reported

c) Suspected side effects d) A report was received

22. __________ not having had anything to eat but a chocolate candy bar
4 hours beforehand.

a) The patient reporting b) The patient

c) The patient reported d) The patient report

23. __________ , the attending physician discontinued Mensamint and


administered a strong sedative.

314
a) After releasing the patient b) After sending the patient
home

c) After examining the patient d) After discharging the


patient

24. After 24 hours, __________ except for a mild skin irritation and the
patient was released from hospital.

a) all drugs had subsided b) all symptoms had


subsided

c) all dosages had subsided d) all medications had


subsided

25. A correlation between the patient's peanut allergy and this adserse
event cannot _______.

a) be ruled off b) ruled out

c) be ruled out d) be out

26. The patient's normal __________ (pulse, blood pressure, respiratory


rate and temperature) were established before the surgery.

a) vital affects b) vital symptoms

c) vital effects d) vital signs

27. The ________ is a European Union agency for the evaluation of


medicinal products.

a) QPPV b) MHRA

c) EMEA d) FDA

28. ______ is a Qualified Person Responsible for Pharmacovigilance.

a) FDA b) EMEA

c) MHRA d) QPPV

29. Choose the sentence with the same meaning as “ Maybe the side effect
was a result of taking this product."

a) The side effect could have been due to taking this product.
315
b) The side effect is due to pre-existing conditions.

c) The evidence of the side effect is conclusive.

d) The side affect could have been due to taking this product.

30. Choose the phrase that has the same meaning as “old illness"

a) pre-existing symptoms b) pre-existing affects

c) pre-existing medications d) pre-existing


conditions

31. ______ is an official publication containing a list of medicinal drugs


with their effects and directions for their use.

a) Pharmacovigilance b) Pharmaceutical
Encyclopedia

c) Pharmacopeia d) Pharmaceutical
dictionary

32. In order to get approval to sell a new drug, a company has to compile
detailed documentation with all the information required by the drug
authorities. Administrative Data include(s):

a) biological, chemical, and pharmaceutical documentation with manufacture,


quality control, and testing data

b) documentation about clinical trials and post- marketing information

c) overviews of quality, clinical, and non-clinical data.

d) general information, such as the marketing authorization application


form, as well as product characteristics and labelling

33. In order to get approval to sell a new drug, a company has to compile
detailed documentation with all the information required by the drug
authorities. Non-clinical Study Reports include(s):

a) documentation about clinical trials and post-marketing information

b) overviews of quality, clinical, and non-clinical data

316
c) study reports, pharmacology, pharmacokinetics, toxicology, and
references d) biological, chemical, and pharmaceutical
documentation with manufacture, quality control, and testing data

34. What does “PIL” mean?

a) Patient information leaflet b) An oral tablet

c) Oral contraceptive tablet d) A small, round piece of medicine


to be swallowed without chewing.

35. Important information for any person taking a drug can be found in:

a) Patient information sheet b) Patient leaflet

c) All of the above d) Package insert

36. A patient can find Important information about a drug in:

a) All of the above b) Patient leaflet

c) Patient information sheet d) Patient information leaflet

37. _________ may contain: a worthless placebo; a lower concentration of


the same active ingredient; a similar, but different substance; a totally
different, potentially dangerous substance.

a) Counter drugs b) Excipients

c) Authentic drugs d) Counterfeit drugs

38. _________ may contain: a worthless placebo; a lower concentration of


the same active ingredient; a similar, but different substance; a totally
different, potentially dangerous substance.

a) Authentic drugs b) Inactive drugs

c) Fake drugs d) Excipients

39. Choose the INCORRECT statement about Counterfeit drugs:

a) Counterfeit drugs may contain a lower concentration of the same active


ingredient

b) Counterfeit drugs may contain a totally different, potentially dangerous


substance.
317
c) Counterfeit drugs are not fake drugs

d) Counterfeit drugs may contain a worthless placebo.

40. Keep ______ of children.

a) within reach b) out of reach

c) in reach d) away

41. A child may find a pill hard to _____.

a) chew b) eat

c) swallow d) drink

42. If symptoms _______, the patient should consult a doctor.

a) resist b) persist

c) consist d) insist

43. This medicine has a bitter ______.

a) afterthought b) aftertaste

c) beforetaste d) aftertest

44. The patient had a _______ condition when he took the medication.

a) adverse b) side

c) ailment d) pre-existing

45. A(n)_____ pain is the pain in your stomach or intestines.

a) abdomen b) abdominal

c) abnormal d) stoma

46. At the hospital, the patient showed evidence of hyperactivity , _______


by confusion and agitation.

a) command b) comment

c) accompanied d) company

318
47. Government agencies, pharmaceutical companies ,and healthcare
professionals work together to _____and evaluate suspected side effects of
medicines to improve the safety of drugs in use

a) auditor b) director

c) monitor d) counselor

48. __________ department is responsible for compiling dossiers for


submission to authorities, submitting documents needed to obtain
marketing approval for a drug, and writing the drug information for the
patient.

a) Regulatory Afraid b) Regulatory Affairs

c) Drug Safety d) Drug Monitor

49. Ms Gallois, the well-known opera singer, lost _______ 30 minutes


before she had planned to go on stage. ( = the condition of being awake and
able to understand what is happening around you)

a) unconsciousness b) consciousness

c) unconscious d) conscious

50. ______ is a drug or method used to prevent a woman from becoming


pregnant when she has sex.

a) contraceptive b) contraindication

c) contraband d) contraindicate

51. Serious adverse event (SAE) - an adverse event that threatens

life, requires or prolongs _______, or results in death.

a) hospitality b) hospitalize

c) hospital d) hospitalization

52. The patient's normal __________ signs (pulse, blood pressure,


respiratory rate and temperature) are established in the pre-operative
period and variations 10% above or below the pre-operative measurement
should be reported immediately.

319
a) Vital b) Vial

c) Viral d) Vitality

53. If you feel _______, you feel that you are losing your balance and are
about to fall.

a) dizzy b) fatigue

c) irritation d) tired

54. If you ______, you lose consciousness for a short time, especially
because you are hungry, or because of pain, heat, or shock.

a) thirsty b) irritation

c) palpitations d) faint

55. Do not take Mensamint TM if you are _______ to penicillin.

a) allergen b) allergy

c) allergic d) allergist

56. The patient has an _____ to peanuts.

a) allergic b) allergen

c) allergy d) allergist

57. The evidence is inconclusive.The facts neither prove nor ____ this.

a) disprove b) confirm

c) affirm d) approve

58. In order to get approval to sell a new drug, a company has to _____
detailed documentation with all the information required by the drug
authorities

a) compile b) compute

c) compound d) combine

320
59. We do need to let patients know of any possible side effects. But, it is
not necessary to _____them unnecessarily.

a) assure b) alarm

c) attack d) assume

60. When describing possible side effects for products in the pipeline, we
will need to ______more clearly between common and rare risks.

a) difference b) determine

c) different d) differentiate

61. A ______ person or a _______ event attracts a lot of attention or


publicity. (= famous)

a) high-profile b) high-protect

c) high-product d) high-profit

62. Our patients shouldn’t be so alarmed that they are afraid to actually
put the pills in their mouth and swallow them. The PIL just needs to reflect
the _______ of side effects.

a) probability b) traceability

c) bioavailability d) profitability

63. It has the same packaging, same colour coating, same bitter _______,
but not the same ingredients inside the pill. Is this a fake drug?

a) dosage form b) aftertaste

c) dosage d) dosage

64. In Europe, steps have been taken to use holograms to prove a


pharmacopeias ______.

a) activity b) authorization

c) authenticity d) active

321
65. ____ is an inactive substance that serves as the vehicle or medium for
a drug or other active substance.

a) Placebo b) Excipient

c) API d) NCE

66. A(n) _____ accident or illness causes someone's death.

a) fatal b) harmless

c) minor d) factual

322
AVCN2_Pharmaceutical Industry Unit 6
1.Choose most suitable expression to complete the following sentence.
_________, requirements have reached a very high standard.

a) When it was founded b) By the time

c) In the meantime d) In the past

2. Choose most suitable expression to complete the following sentence.


_________, the company only had one production site.

a) By the time` b) Nowadays

c) When it was founded d) In the meantime

3. Choose most suitable expression to complete the following sentence.


_________ the safety film, I will give you more detailed information on the
company.

a) Meanwhile b) During

c) By the time d) While

4. Choose most suitable expression to complete the following sentence.


_________ the tour is finished, you will have seen the most important
production areas.

a) While b) Once

c) During d) Meanwhile

5. The clothing specifications _______ documented.

a) use to b) didn’t use to be

c) didn’t use to d) use to be

6. The company’s safety regulations _____ so strict.

a) use to b) didn’t use to be

c) use to be d) didn’t use to

7. The company’s _______ regulations didn’t use to be so strict.

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a) safety b) securely

c) secure d) safe

8. Dry ingredients are weighed and transported to the granulator by the


______.

a) sieve b) dispenser

c) hoist d) granulator

9. In the _______, the ingredients are mixed to create a wet mixture.

a) dispenser b) sieve

c) granulator d) hoist

10. The granules are air-dried in the _____ .

a) granulator b) sieve

c) drum d) fluid bed dryer

11. The excess powder is loosened by a _______.

a) drum b) sieve

c) dryer d) shaker

12. In the _____, the dried granules are stamped into a mould to form
tablets.

a) granulator b) tablet press

c) fluid bed d) sieve

13. Primary packaging is the material which is ________.

a) not in direct contact with the product. b) the final consumer packaging.

c) in direct contact with the product. d) the final product packaging.

14. Secondary packaging is the material which is ________.

a) in direct contact with the product. b) not in direct contact with the
product.

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c) the final consumer packaging. d) the final product packaging.

15. A(n) __________ is a small disposable bag containing an individual dose


of the medicine. It often has a lengthwise perforation which can be torn
open.

a) blister pack b) jar

c) inhaler d) sachet

16. A(n) __________ is an aerosol dispensing device which releases


medication into the mouth of the patient. The medication is breathed
deeply into the lungs, or stays in the mouth or throat.

a) sachet b) inhaler

c) blister pack d) jar

17. A(n) __________ is a needle attached to a plastic tube used for putting
medicine into the body or removing blood.

a) inhaler b) jar

c) sticky label d) syringe

18. A(n) __________ is a piece of paper attached with adhesive to the


primary packaging to identify it and give details concerning its ownership,
nature, and/or use.

a) inhaler b) jar

c) syringe d) sticky label

19. A jar is _______

a) a type of single-use plastic container, and is used for pharmaceutical


products as well as for other consumer goods. The product is placed in the
formed cavity and sealed by lidding foil. The product is removed by pushing it
through the foil.

b, an aerosol dispensing device which releases medication into the mouth of the
patient. The medication is breathed deeply into the lungs, or stays in the mouth
or throat.

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c) a multi-use glass container with a twist-on lid. It can hold
pharmaceuticals, or any kind of fluids or solids. It can be opened and
closed several times until the contents are used up. Sometimes a desiccant is
integrated into the cap so that the contents remain dry.

d, A small disposable bag containing an individual dose of the medicine. It


often has a lengthwise perforation which can be torn open.

20. A sachet is _______

a) a type of single-use plastic container, and is used for pharmaceutical


products as well as for other consumer goods. The product is placed in the
formed cavity and sealed by lidding foil. The product is removed by pushing it
through the foil.

b, an aerosol dispensing device which releases medication into the mouth of the
patient. The medication is breathed deeply into the lungs, or stays in the mouth
or throat.

c) a small disposable bag containing an individual dose of the medicine. It


often has a lengthwise perforation which can be torn open.

d, a multi-use glass container with a twist-on lid. It can hold pharmaceuticals, or


any kind of fluids or solids. It can be opened and closed several times until the
contents are used up. Sometimes a desiccant is integrated into the cap so that the
contents remain dry.

21. What type of packaging material is a syringe?

a) Secondary b) Both primary and secondary

c) Primary d) Tertiary

22. What type of packaging material is a sachet?

a) Tertiary b) Primary

c) Secondary d) Both primary and secondary

23. Which primary packaging would you recommend for nose drops?

a) inhaler b) blister pack

c) sachet d) bottle

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24. Which primary packaging would you recommend for ointments?

a) sachet b) bottle

c) inhaler d) tube

25. Which primary packaging would you recommend for oral tablets?

a) blister pack b) tube

c) syringe d) sachet

26. Which primary packaging would you recommend for eye drops?

a) jar b) blister pack

c) tube d) bottle

27. To use a blister pack, you ______ it

a) tear b) push through

c) press d) twist

28. A patient needs to ______ an inhaler to use it.

a) push through b) twist

c) tear d) press

29. Choose the CORRECT matching of packaging material and the verb
used to describe how to use them:

a) a sachet - push through b) an inhaler - tear

c) a jar - twist d) a blister pack - press

30. A lot of research is done to make packaging ______ ,i.e. a child cannot
open it alone.

a) childproof b) elderly-accessible

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c) child-accessible d) childrenproof

31. In a ______ container system, a closure must be pushed down before


it can be unscrewed.

a) squeeze-screw b) peel-push

c) slide d) push-screw

32. In a push-screw container system, a closure must be ______ before it


can be unscrewed.

a) aligned b) peeled off

c) squeezed d) pushed down

33. In a ______ container system, a first layer must be peeled off a blister
before the drug can be pushed through the second layer.

a) push-screw b) squeeze-screw

c) peel-push d) slide

34. In a peel-push container system, a first layer must be ______ a blister


before the drug can be pushed through the second layer.

a) aligned off b) peeled off

c) pushed off d) squeezed off

35. In a ______ container system, a container with three buttons that must
be aligned in order to slide off the lid.

a) peel-push b) push-screw

c) slide d) squeeze-screw

36. In a slide container system, a container with three buttons that must
be ______ in order to slide off the lid.

a) pushed b) squeezed

c) aligned d) peeled

37. What does it mean by ‘security’

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a) Following rules and regulations b) Freedom from danger or
harm

c) Protection from threats, such as attacks or d) Working as part of a


team

crime.

38. Our documentation must be improved to _____ the requirements of


the regulatory authorities.

a) find b) meet

c) met d) like

39. If a pill has a brightly-coloured _______ a child may mistake it for a


sweet.

a) dosage b) coating

c) dose d) coated

40. Choose the word that mean the same as “uncomplicated”

a) sample b) simple

c) complex d) complexity

41. Nowadays, RRB is a research-driven, innovative pharmaceutical


______ that develops new drugs, produces them, prepares them for sale,
and markets them worldwide.

a) API b) PIL

c) enterprise d) NCE

42. _______ tablets are uncoated tablets containing substances that react
in the presence of water and give off carbon dioxide.

a) effervescent b) chewable

c) sustained release d) sublingual

43. A _____ must be worn at all times in this area to protect your head.

a) safety goggles b) hard hat

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c) lab coat d) soft hat

44. Safety is the _____

a) freedom from danger or harm. b) same as security

c) All of the above d) protection from threats,


such as attacks or crime.

45. If you give instructions in a very direct way, it may not sound _____.

a) impolite b) correct

c) polite d) incorrect

46. The ______ is removed by the hot air in the fluid bed dryer.

a) powder b) tablet

c) granule d) moisture

47. A jar is a multi-use glass container with a twist-on lid. Sometimes a(n)
_____ is integrated into the cap so that the contents remain dry.

a) desiccant b) excipient

c) humidity d) preservative

48. _________ is the amount of water vapor in the air

a) humid b) humidity

c) humanity d) human

49. A sachet is a small ______ bag containing an individual dose of the


medicine. It often has a lengthwise perforation which can be torn open.

a) reusable b) disposable

c) multi-use d) desiccant

50. __________ means a child cannot open it alone.

a) child safety b) children protection

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c) child proof d) child prevention

51. Because of her son's death, the young mother _____(ed) that

safe-disposal boxes be included in the packages of medicated patches.

a) demand b) anticipate

c) negligence d) discard

52. Safe-disposal boxes should be included in the packages of medicated


patches. These boxes should have a small slit at the top to _____ used
patches and it should be impossible to open them.

a) negligence b) anticipate

c) demand d) discard

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