Professional Documents
Culture Documents
Ta 3
Ta 3
5. Charles Wu, from China will be connecting with us…. Vide conference
A. By
B. With
C. Over
D. In
Once pharmacists have (1)… the industrial sector, (2)… is a lot of scope for
moving “up or sideways” . says Halliday, who (3)… entered the industry (4)…
a bench scientist directly after completing her PhD at the University of
Strathlyde. She adds the mani¥y individuals start in laboratory – based roles anf
the quickly progerss into other (5)…., (6)…. Quality asssurance
If you want to work in research, (7)…. qualifications are essetial to prove your
credentials but, for most roles, it is not necessary to have an advanced research
degree, Halliday (8)… out. However, other roles will provide (9)… to study
while you work and (10) …. Professtional development is expected.
Including
Points
There
Further
Departments
Opportunities
Jioned
Approprivate
Herself
As
The main reason I am writing to you today is to remind you that we still need
you to propose people from your departments to work on our new soft gel
capsule for headaches and to liaise with your departments. As you know, it will
be a prescription drug, so people with experience in analgesics are the ones
we’d most like to have on board.
A. project managers
B. project directors
C. heads of departments
D. None is correct
A. one thing
B. two things
C. three things
D. four things
4. It can be inferred from the memo that their new soft gel capsule for
headaches is .................
A. a drug
B. a medicine
D. a prescription drug
D. None is correct.
1. The Department of Research and Development finds new substances to make
new drug ................. or change existing dosage forms.
A. forms
B. formulates
C. formulas
D. formulations
2. The most important reason for this memo is to ................. information about a
new drug.
A. talk
B. take
C. say
D. give
A. working
B. prescription
C. generic
D. compulsory
A. creative
B. passive
C. active
D. captive
5. 68% of the patients currently take either tablets, pills, or capsules for
various ................ .
A. ill
B. ailments
C. problems
D. medication
A. far
B. father
C. farther
D. further
D. substance
A. substitute
B. sustain
C. subject
8. What kind of time frame are we taking about on the first ................. study?
A. on man
B. in man
C. in-man
D. on-man
A. self-control
B. self-taught
C. self-study
D. self-medicate
10. In Russia, when foreign companies try to introduce drugs, the Russians ask
them for good ................. training programmes.
A. In pharmacy
B. on pharmacy
C. on-pharmacy
D. in-pharmacy
II. Read the sentence and decide if it is True (T) or False (F) by choosing
the answer A or B.
A. T B. F
A. T B. F
A. T B. F
A. T B. F
III. Read the text below and choose ONE suitable word from the given ones
to fill in each numbered blank.
A Clinical Research (1) .................. (CRA) has an important task within the
clinical trial process. He/she has the key (2) .................. to verify that the safety,
rights and well-being of human (3) .................. are (4) .................. and that the
reported clinical trial data are (5) .................., verifiable from source documents
and complete. Most (6) .................., the CRA makes sure that the conduct of the
trial is in compliance (7) .................. the recently approved protocol or
amendment(s) protocol, with good clinical practice (GCP), and with applicable
regulatory authority (8) ................... The CRA performs clinical site (hospital)
monitoring and (9) .................. clinical research documents, (10) ..................
clinical study protocol.
You are probably aware that “CoolHead” is just the working name of the new
drug. The soft gel capsule will be followed soon afterwards by two other dosage
forms also in the pipeline: patches and sugar-coated tablets. We plan to launch
all of these products in Europe first and to apply for Food and Drug
Administration (FDA) approval in the US the following year.
We still need project team members for R&D, Regulatory Affairs, and QA. As
far as Marketing is concerned, Carole Marks will be flying in from France.
She’ll give us more information on the marketing claims and a target patient
profile. From Clinical Affairs in Italy, Anna Edicola will present the clinical
requirements. She, as well as Charley Wu from Production, will be connecting
with us by video conference.
1. “CoolHead” is ................
3. All of these products are planned to apply for Food and Drug Administration
(FDA) approval in the US .................
A. next year
A. three
B. four
C. five
D. six
IV. Read the memo and choose the answer A, B, C or D to fill in the blanks
with missing
information.
SAMPLE TEST 3
2. Laboratory gowns or lab coats, latex gloves, and safety glasses ................. at
all times.
A. must be wear
B. must be worn
C. must wear
D. must be wearing
3. I suggest that they also check the equipment lists to make sure each
workstation ................. all the correct equipment.
A. have
B. had
C. has
D. having
4. If the auditors observe any ................., they will write it down on their
checklist and we’ll be informed so that we can take corrective or preventive
action.
A. difference
B. non-compliance
C. failure
D. fake data
A. a
B. the
C. some
D. any
A. criteria
B. curriculum
C. standards
D. targets
7. Inspection and validation are required to prove that manufacturing and testing
equipment is ................. clinical
B. functional
C. approval
D. fundamental
A. approach
B. process
C. processes
D. method
9. The ................. required for all research processes and development steps
ensures the traceability of a drug.
A. documentation
B. traceability
C. inspection
D. validation
B. laboratory
C. manufacturing
D. entire
II. Read the sentence and decide if it is True (T) or False (F) by choosing
the answer A or B.
1. To ensure that laboratory workers are asked certain questions about safety
procedures, auditors use a checklist.
A. T B. F
A. T B. F
A. T B. F
5. Safety procedures make sure that the health and well-being of laboratory
workers are guaranteed.
A. T B. F
III. Read the text and choose the answer A, B, C or D to fill in the blanks
with missing information.
The US only has two official categories for drugs: drugs needing a prescription
and drugs that do not. The former are prescription drugs and are available in
pharmacies and only by prescription. The latter are over-the-counter drugs
which can be sold in any type of retail outlet that chooses to stock “them”.
In general, in the US, medication must meet four criteria in order to obtain the
status of non-prescription or over-the-counter (OTC) product. “It” must have:- a
large margin of safety- low incidence of side effects
- low potential for misuse and abuse, and- labeling that provides adequate
directions for sale and effective use.
C. OTC drugs
A. official categories
C. retail outlets
A. the US
B. medication
C. criteria
D. the status
B. principles (B)
IV. Read the text below and choose ONE suitable word from the given ones
to fill in each numbered blank.
The quality assurance process in good (1) .................. practice (GMP) includes
product quality control, sampling, and (2) ................... Quality control
(3) .................. that the product quality remains (4) .................. The reason for
interim testing, or product sampling, is to (5) .................. the quality of
pharmaceutical products. This is (6) .................. to make sure that the product is
suitable for its intended use and for (7) .................. Endpoint testing is
(8) .................. out at the end of (9) .................. manufacturing process. This is
to ensure that all procedures have been performed in (10) .................. with
industry and company standards. (88 words)
1. In the …. Workers test or organize testing on live subjects and make sure
that their drug are safe and effective for the patients
A. Clinical affairs
B. Regulatory affairs
C. Quality insurance
D. Production
2. In the department of production, they compound the raw into drugs,….
Them and out in the leafters for the patients.
A. Produce
B. Study
C. Test
D. Package
3. The department ok production also keeps careful…. Of all the steps in the
process
A. Documents
B. Records
C. Numbers
D. Data
12. Patients… want to buy this kind of drug will not need see a doctor first
A. who
B. which
C. whom
D. whose
14.the company plans to sell the drug …. Europe and the U.S
A. on
B. at
C. in
D. at
15.projects members from marketing, production, and clinical affairs ar
already … board
A. on.
B. At
C. In
D. At
16.The most impartant reason for this memo is to… information about a new
drug
A. Talk
B. Take
C. Say
D. Give
18.the… meeting for the first gathering of people who will work in this
project will take place on March 6th in the international hotel
A. final
B. kick-off
C. only
D. most
23. in the department of regulatory affairs, they compile the… and send it to
the regulatory drug authorities
A. production processes
B. preclinical data
C. drug documentation
D. patient records
24. the company needs to know which drug dosage forms patient…. ?
A. like
B. choose
C. prefer
D. take
31. A lot of question about laboratory safety might be asked during an….
Audit procedure
A. internal
B. external
C. superior
D. interior
32.we are preparing for the laboratory safety prucedures internal audit….
Two weeks
A. on
B. in
C. about
D. at
36.Small…. Spills must be covered with a paper towel and treated with
bleach
A. Chemical substance
B. Sentences
C. Compound
D. Biological agent
39.…. Is an condition in which a part of the body becomes red, warm, and
swollen
A. adverse event
B. inflamination
C. side effect
D. serious adverse event
44. if the auditiors observes any… , they will write it down on their checklist
and we will be informed so that we can take corrective or preventive
action
A. difference
B. non-complicance
C. failure
D. fake data
45.I suggest that they also check the equipment lists to make sure each
workstation …. All the correct equipment
A. Have
B. Had
C. Has
D. Having
46.May I just suggest that the junior lab technicians… these two items?
A. Works
B. Take care of
C. Solve
D. Take care on
49. We have to… special lab coats, safety gloves, hairnets, and overshoes in
the laboratory
A. try
B. take off
C. try on
D. wear
50.….. is the ability of drug to treat the illness for which it was developed.
A. Efficacy
B. Eddervescent
C. Efficienty
D. Effectiveness
51.In my opinion, the…. Studies for this drug will take more than six months
A. In-men
B. For-man
C. For-men
D. In-man
53. Quality control involes …. And product sampling procedures, which are
carried out to check product quality
A. interval
B. interim
C. internal
D. intercept
54.even a product that has been marketed fo years might have to be…. The
market in a product recall if serious adverse reactions occur
A. taken from
B. taken over
C. taken off
D. taken up
56. contaminated products are no longer pure and,… sale or public use and ,
therefore , must be returned to the manufacturer , or destroyed
A. accepted for
B. unaccepted for
C. acceptalble for
D. unacceptable for
59. endpoint testing is carried out at the end of every manufacturing process ,
which is to ensure that procedures have been performed in compliance
with industry and company….
A. Criteria
B. Curriculum
C. Standards
D. Targets
62. All operational methods and procedures must also be inspected for…
A. accuracy
B. accurating
C. accurate
D. accurated
63. our goal is to identify any areas requiring corrective and …. Action
before a summary report of the status os these action is issued
A. active
B. passive
C. preventive
D. productive
65. The complete checklist and… audit results will be reviewed with you
and the research and development vice president
A. original
B. first
C. draft
D. only
66. The junior lab technicians will be cleaning the laboratories and checking
the… equipment lists
A. place
B. base
C. floor
D. workstation
68. small biological …. Spills must be covered with a paper towed and
treated with bleach
A. act
B. agent
C. thing
D. item
69.…. Is a solid medicine which melts slowly in the rectum or vagina
A. aerosol
B. solution
C. suppository
D. capsule