Q1- Biological half-life of is calculated as, Which of the following is the right answer

A-t% 0.693 x CL/Vd

B-t%= 0.693 x K/In2
C- t=0.693 x Vd/CL
D- t% 0.693 x In2/K
E- None of the above

Q2)- Animals have served humans in their search for drugs in a number of ways. Which of the following
is the right answer
A- Drug testing
B-Biologic assay
C- Provided drugs
D-All the above
E- None of the above.

Q3-To improve the solubility of slightly soluble drug the formulator should do the following, which of
the following is the right answer
A-Use the salt form of the drug
B-Use the ester form of the drug
C-Use a complex of the drug with a complexing agent.
D-decrease the particle size to increase the surface area
E- All of the above

Q4- Regarding containers, the required qualities tested

A-Moisture barrier
B-Drug compatibility
C-Toxicity for plastics
D-Leaching
E-Leaching, toxicity for plastics, drug compatibility and moisture barrier

Q5- Using the Fick Law of Diffusion how will flux change if membrane thickness is doubled?
A-It will double
B- It will quadruple
C-It will halve
D-It will quarter
E- It will not change

Written By Ph.Yousif Jawad

Q 6-types of stability concern pharmacists are all the followings EXCEPT
A-Microbiologic: Sterility or resistance to microbial growth is retained according to the specified
requirements.
B-Spherical stability: concerning particle size and shape and surface area.
C-Chemical: Each active ingredient retains its chemical integrity and labeled potency within the specified
limits.
D-Therapeutic: The therapeutic effect remains unchanged.
E-Physical: The original physical properties, including appearance, palatability, uniformity, dissolution,
and suspendability, are retained

Q7))-Regarding new drug development and approval process, Sources of new drugs may be from:
A- plant
B-lab by accident
C-semisynthetic
D-rDNA
E-plant, lab. by accident, semisynthetic and rDNA

Q8-Regarding different type of package, Which of the following packaging type is described correctly?
A- Tamper-evident packaging means a container that is fitted with a closure that is significantly difficult
to open by children X less than 5 years of age
B-Moisture resistance container is obtained by adding UV absorbance to transparent plastic
C- Single dose parental container is one that allow withdrawal of successive dose without changing of
the content quality
D-Compliance packaging means unit or quantity of drug to be use, so it is useful for patients taking
multiple medications
E- All of them

Q9- What equation describes the degree of ionization of drug?

A- Fick's law
B-Henderson-Hasselbach equation
C-Law of mass action
D-Michaelis-Menten equation
E- Noyes Whitney equation

Q 10- Which of the following statements is incorrect?

A- the amorphous form of a drug is always more soluble than the corresponding crystalline form
B- generally, the anhydrous form of the drug dissolves more rapidly in water than the hydrous form

Written By Ph.Yousif Jawad

C-solubility of a weak acid can be increased by adding a conjugate base
D-Different polymorphs have different chemical structure
E- Amorphous form has less melting point than crystalline

Q11-Time course for the development of new drug from discovery till approval should be: Which of the
following is the right answer
A-7 Years
B-9 Years
C-11 Years
D-13 Years
E-15 Years

Q12- The dissolution rate of drug, which of the following is the right answer
A-controlled by ficks low
B-controlled by Henderson-Hasselbach equation
C-Michaelis-Menten equation

D-Noyes Whitney equation

E-None of the above

Q 13- Concerning organic compounds as a flavoring agent: which of the following is the right answer
A-There is no relation ship between number of hydroxyl groups and sweetness
B-As number of hydroxyl groups decrease the degree of sweetness increase
C- As number of hydroxyl groups increase the degree of sweetness increase
D- All of the above.
E-None of the above

Q 14- Regarding control of components, containers and closures regulations, which one is not true?
A- The label of quarantined rejected raw material is not enough to carry only name of material
B-Raw materials should verified through sampling for qualitative and quantitative analysis
C-Starting raw materials do not necessarily need to be tested if there is a batch analysis certificate from
the supplier
D-Validation of identification, storage, handling, and approval or rejection of all product components,
containers, and closures must be maintained and followed
E-None of them

Q 15- Concerning prodrugs they are usually used for the following reason:
A-To change the solubility.

Written By Ph.Yousif Jawad

B-To change the absorption.
C-To change biostability.
D-To prolonged release.
E- All the above

Q 16- To protect drug from destructive influences of atmospheric oxygen or humidity it should be
prepared as:
A-It should be prepared as tablet
B- It should be prepared as capsule
C-It should be prepared as coated tablet
D- All the above
E- None of the above

Q17-Conditions under which the FDA may waive the bioavailability requirement are: Which of the
following is the right answer

A- The product is a solution intended solely for IM administration

B-The oral drug products like solution, elixir, syrup of different concentration.
C- The drug is a topically applied preparation which intended for local effect.
D- All tablet dosage forms.
E-The product is a solution intended solely for IV administration

Q 18- During Phase 2 clinical studies, Which of the following is the right answer?
A- oral drugs capsules are employed containing active ingredient alone
B- oral drugs capsules are employed containing active ingredient and diluent
C- oral drugs capsules are employed containing active ingredient and diluent
D-final dosage form should be given
E- none of them.

Q 19- Active transport differs from facilitated transport in following ways, EXCEPT
A-Carrier is involved
B- It is against concentration gradient
C-Energy is required
D-It is from low concentration to high concentration
E- All of the above

Written By Ph.Yousif Jawad

Q 20- Preparation of enteric coated tablet usually made to: Which of the following is the right answer
A-Protect the drug from degradation by the hydrochloric acid of stomach
B-Protect the stomach from irritation by the drug
C-Both A and B
D-To protect the drug from degradation by environment
E-None of the above

Q21-recombinant DNA: techniques, which of the following is the right answer

A-happen entirely within the cells of higher animals
B-has the ability to produce any wanted protein
C- produce a desired antibody and stimulates an unending stream of pure antibody production
D-used diagnostically for home pregnancy testing products.
E-used to check stage and to localize malignant cells.

Q 22-Regarding organization and personnel regulations, which one is not true?

A- Adequate laboratory facilities shall be provided and written procedures followed
B-Quality controlled staff may be exempt from training because they are generally better educated
C-Personal shall practice good sanitation and health habit
D-Staff must have a clear job description which determine their role and responsibilities
E- None of them

Q23- Which of the followings can produce a therapeutic response? A drug that is:
A-Bound to plasma albumin.
B- Concentrated in the bile.
C-Concentrated in the urine.
D-Not absorbed from the GI tract.
E-Unbound to plasma proteins

Q 24- Regarding the common terms in GMP, Which of following term is defined correctly?
A-Certification: is the extent to which manufacturer is acting with prescribed regulations, standards, and
practices
B-Process validation is prospective experimental plan to produce documented evidence that the system
has been validated
C- Compliance is documented testimony by qualified authorities that a system qualification, calibration,
validation, or revalidation has been performed appropriately and that the results are acceptable
D- Quarantine is a marked, designated area, or set aside for the holding of incoming components prior
to acceptance testing and qualification for use

Written By Ph.Yousif Jawad

E- None of them

Q 25-Parenteral glass containers used in packaging of pharmaceuticals, which of the following is the
right answer
A-Type I glass containers
B-Type IV glass containers
C-Glass made from coextruded two-layer high-density polyethylene bottle.
D-Glass made from poly ethylene glycol
E-None of the above.

Q 26- Which one of the following is primarily NOT a chemical decomposition?

A- isomerization
B-hydrolysis
C- oxidation
D-volatilization
E- deamination

Q27-Formulation components of a modified delivery system that does not directly control the release of
the active drug from the system include: which of the following is the right answer
A- matrix formers
B-channeling agents
C- Membrane formers
D-solubilizers
E-lubricants

Q 28-A tamper-evident package, which of the following is the right answer

A- is impervious to air or any other gas
B- protects contents from solids and from loss under ordinary conditions.
C- one having one or more indicators or barriers to entry
D- when opened, cannot be resealed
E-none

Q 30- Chemically, the most frequently encountered destructive hydrolysis processes usually occurs in
the following products EXCEPT
A- esters
B-amides
C- phenols

Written By Ph.Yousif Jawad

D-: lactams
E-lactones

Q 31-Comparing plastic material to glass for packaging, which one is correct?

A- Plastic can be used for packaging sterile products
B-Glass is more mandibles in design, modification and consumer acceptance
C- Glass is lighter with lowest cost for transportation
D-Plastics are divided into four types according to their resistance to water attack and alkali release
E- None of them

Q 32- Selection of appropriate flavor depends on several factors: which of the following is the right
answer A-Cocoa-flavored mask the salty taste of drug.
B-Fruit or citrus flavors mask the sour or acid-tasting of drug.
C- Cinnamon, orange, raspberry, mask the bitter taste of preparations
D- Adult prefers fruit flavors.
E-Children prefers tart flavors.

Q 33- Which of the following statements on the Passive diffusion is incorrect:

A-not need a carrier
B- not need energy
C-the primarily mechanism for drug absorption
D-the main mechanism for absorption of proteins
E-occurs with concentration gradients

Q 34- Regarding holding, storage and distribution of pharmaceutical product, which one is correct?
A- Finished pharmaceuticals must be quarantined in storage until released by the quality control unit
B-Storage conditions generally have no impact on shelf-life or quality
C- The oldest approved stock is ordinary last one to be distributed
D-Storage and distribution arrangement are not the responsibility of the manufacturer once it has left
his factory
E- None of them

Q 35- Which mechanism is most often responsible for chemical degradation? Which of the following is
the right answer
A-Racemization
B- Photolysis
D- Decarboxylation

Written By Ph.Yousif Jawad

C-Hydrolysis
E-Deamination

Q 36- Acesulfame is more used in candy, chewing gum, and instant coffee and tea than aspartame
because it is: which of the following is the right answer
A- Sweeter than aspartame
B-Contains higher OH groups than aspartame
C-More stable than aspartame
D- Easier to be digested in stomach than aspartame
E- Has a cooling sensation in mouth

Q 37- Dissolution is process by which a drug particle dissolves. For a drug to be absorbed, it must first
dissolve in the fluid at absorption site. The saturation solubility of the drug in solution in the diffusion
layer surrounding the dissolving particle can be increased by:
A- Increasing the temperature
B-Increasing the agitation rate
C-Decreasing the particle size
D-Increasing the temperature and increasing the agitation rate
E-Increasing the temperature, decreasing the particle size and increasing the agitation rate

Q 38- All equipment used in process should be calibrated and checked for effectiveness and
performance?
A- Before an inspector comes
B- Before the manager comes into the department
C-Routinely according to a scheduled basis
D- After finishing the production process and workers have leaved
E-None of them

Q39-Concerning Carcinogenicity Studies of new drug during clinical studies: which of the following is the
right answer
A-done on animal female.
B- should be studied on two animal species.
C- Done on animal male.
D-Should be done on birds
E-Should be done on Salmonella.

Q40-Drug labeling includes not only the labels placed on an immediate container but also the

Written By Ph.Yousif Jawad

information present in package insert involves: which of the following is the right answer
A-adverse effects
B- Contraindications
C-Indications
D-Overdosage symptoms
E- All the above

Q41-Certain cells within the body capable of binding to drugs without any effect so they act as: Which of
the following is the
right answer
A-complementary
B- reversibly
C-binders
D-carriers
E receptors

Q42- Concerning salts as excipients in formulation of dosage forms: which of the following is the right
answer
A-high-molecular-weight salts are salty, and low-molecular-weight salts are bitter in taste.
B-low-molecular-weight salts are salty, and high-molecular-weight salts are bitter in taste.
C-low-molecular-weight salts are sweety, and high-molecular-weight salts are salty in taste.
D-high-molecular-weight salts are salty, and low-molecular-weight salts are sweety in taste.
E-low-molecular-weight salts are salty, and high-molecular-weight salts are sweety in taste.

Q 43- According to ability of containers to protect their content from ordinary external condition of
handling, shipment, storage, and distribution, which is not true?
A- Amber glass or opaque plastic containers can sufficiently protect a moisture sensitive pharmaceutical
substance
B-Hermetic containers can maintain sterilization of preparations intended for injection or parenteral
administration
C-Tightly close containers can protect contents from contamination by liquids, solids or evaporation
D- Well closed containers can just protect content from solid or prevent content loss
E- None of them

Q44- Molecular modification, which of the following is the right answer

A- Changing physical or chemical properties (e.g., solubility) to provide desired features.
B-enhancing specificity for a particular body target site.
C- Improving rate and extent of absorption.
D-Modifying time course in the body.

Written By Ph.Yousif Jawad

E- all the above

Q45- Active pharmaceutical ingredient, which of the following is the right answer?
A- Any component has the ability to improve flowability
B- Any substance that has physical and chemical stability
C- Any component has pharmacologic activity
D- Any substance that has the ability to disintegrate dosage form
E- Any substance that is stable in room temperature.

Q46- Aspirin undergoes decomposition in a formulation. It can be prevented by: which of the following
is the right answer
A- adding a chelating agent
B- adding an antioxidant
C- protecting it from light
D- suppressing its solubility
E- Add lubricant

Q47- Which of the following is NOT needed for drug bioequivalence?

A- Same active ingredients
B- Same strength or concentration
C-Same dosage form
D- Same route of administration
E- Same side effects

Q48-Regarding Pre-formulation Studies, liquid drugs can be formulated as tablets through

A- direct compression of liquid drug without any preprocessing
B-liquid sealed in soft gelatin capsule
C-drug developed into solid ester or salt
D-mixing drug with a solid or melted semisolid material
E-sealed in soft gelatin capsule, drug developed into solid ester or salt and: mixing drug with a solid

Q 49- To study the effect of new drug on reproductive system the new drug should be studied according
to the following:
which of the following is the right answer

A- It should be studied on mammalians.

B- It should be studied on birds.
C-It should be studied on Salmonella typhemorium.
D-It should be studied on horses.

Written By Ph.Yousif Jawad

E-It should be studied on insects.

Q 50- Aspartame is not used in candy, chewing gum, and instant coffee and tea because it is: which of
the following is the right answer
A-less sweet than other sweeteners
B- Contains a smaller number of OH groups than saccharin
C-less stable than other sweeteners in heat
D-difficult to be digested
E- Has a cooling sensation in mouth

Q 51- The c in cGMP stands for: which of the following is the right answer
A- up to date
B-Commitment
C-Current
D-Content
E-Concentration

Q52- Which of the following statements about particle size reduction is incorrect?
A- particle size reduction results in an increase in the surface area
B-particles with smaller sizes generally dissolve at a faster rate
C- particle size reduction can always improve drug bioavailability
D-the bioavailability of lipid soluble drugs can be improved by particle size reduction
E- optimizing the particle size of drugs is a common practice in the pharmaceutical industry

Q 53- Regarding Lot number of each batch, what is the indication that can be obtained from lot number?
A- Quality and specification standard for the prepared batch
B- Batch expiration date
C- Batch history such as its processing, packaging, storage and distribution
D- Batch registration for marketing approval
E- All of them

Q 54-Regarding good manufacturing practice, establishment of good manufacturing practices

regulations are required for?
A- Preventing and expecting cross-contamination and mix-up
B- Prevent injury or death due to side effects of the drug
C- Save the cost by minimizing the inherent risk
D- Preventing wrong label of finished product

Written By Ph.Yousif Jawad

E- All of them

Q 55- Regarding passage of drug molecules across biologic membranes to produce a biologic response,
equation governs absorption through membrane
A- First flicks law
D- First order kinetic
B-Noyes-Whitney
E-second order kinetic
C- Stock

Q 56- Which one of the following is an example of the chemical modification of an active pharmaceutical
ingredient?
A-Converting a crystalline API into an amorphous form
B- Combining a basic API with citric acid to produce the citrate salt of the API C-Mixing a poorly soluble
API with water to produce a suspension production D-Mixing a soluble API with water to produce a
solution
E-Converting amorphous API into a crystalline form

Q 57- Phase IV clinical studies: which of the following is the right answer
A- is a part of clinical trials in the (process and time from drug discovery to approval for marketing)
scheme.
B- is a part of post marketing in the (process and time from drug discovery to approval for marketing)
scheme
C-is a part of preformulation in the (process and time from drug discovery to approval for marketing)
scheme.
D-All the above
E-None of the above

Q58-Entry of a drug in the central nervous system is enhanced if the drug is, which of the following is the
right answer
A-lonized
B-More lipid soluble
C- Given intravenously
D-Highly plasma protein bound
E-Highly metabolized

Q59-Chronic toxicity studies for new drug means: which of the following is the right answer

Written By Ph.Yousif Jawad

A-Administration of the drug to the animal three times a day for 30 days then check the animal for 1-2
years.
B-Administration of the drug to the animal three times a day for 60 days then check the animal for 1-2
years.
C-Administration of the drug to the animal three times a day for 90 days then check the animal for 1-2
years.
D-Administration of the drug to the animal three times a day for 120 days then check the animal for 6
months.
E-Administration of the drug to the animal three times a day for 150 days then check the animal for 6
months.

Q 60- Regarding vaccines: which of the following is the right answer

A-Poliomyelitis vaccine is prepared in cultures of renal monkey tissue

B-Mumps and influenza vaccines in fluids of chick embryo

C-Rubella (German measles) vaccine in duck embryo
D-All the above
E- None of the above.

Q 61- Plant materials have served as a reservoir of potential new drugs therefore the number of
medicinal plants present in the world are: which of the following is the right answer
A-100.000 plant
B-720.000 plant
C-270.000 plant
D-170.000 plant
E- 700.000 plant

Q 62- Every dosage form is a combination of drug and different kind of non-drug components called:
which of the following is the right answer
A- Additives
B-Non-Additives
C- New chemical entity
D-Medicinal agent
E-receptor

Q 63- Rats have served humans in their search for drugs in a number of ways EXCEPT
A- drug testing
B-biologic assay

Written By Ph.Yousif Jawad

C- provided drugs
D- studying toxicologic effects on rats in additional to another animal species.
E- ex-vivo study

Q 64- Concerning plasma concentration time curve of drug, which of the following is the incorrect
answer
A- At Cmax rate of absorption equal to the rate of elimination
B- Absorption does not terminate after the peak blood level is reached; it may continue for some time.
C- The peak height concentration called (Cmax)
D- In absorption phase there is no elimination
E-Time zero the blood concentration of drug should be zero.

Q 65- Erythromycin undergoes acid-catalyzed hydrolysis in gastric acid. Its stability in gastric acid can be
improved by which of the following is the right answer
A- administering with meals
B- formulating it as coated tablet dosage form
C-formulate it as flavoring suspension
D-formulating it as enteric coated tablet dosage form
E-formulate it as flavored syrup

Q 66- Regarding pharmacological studies, pharmacological studies using whole animal, all are correct
EXCEPT one:
A-Small animals such as rat are most commonly used.
B-The aim of animal study is to predict safety and effectiveness in human.
C- Animals are considered absolute predictors of human response.
D- Dogs are an ideal model for diuretic drug testing.
E-At least two animal species tests are required by FDA for new drug approval.

Q 67-Regarding the preformulation studies, melting point of drugs is an indication of, all are correct
EXCEPT one:
A- Drug purity.
B-Drug plasma half-life.
C-In some cases, drugs compatibility.
D-the presence of different polymorphism.
E-Drug stability

Q 68- The drug hydrolysis is considered first order, when?

A- the rate is constant with increases in concentration
B-the rate decreases with increases in concentration

Written By Ph.Yousif Jawad

C- the rate increases with decreases in concentration
D- the rate decreases with decreases in concentration
E-none of above

Q69- Are properties of Aspirin decomposition EXCEPT

A- remarkable odor
B-citric acid
C- Acetic acid
D- salicylic acid
E- None of above

Q 70- Which one of the following does not define prodrug design purpose?
A-solubility
B-absorption
C- biostability
D- prolonged release
E-bioequivalency

Q71-As New drugs may be discovered from hormonal substance? All EXCEPT ?
A-thyroid extract
B-insulin
C-pituitary
D- inulin
E-all of the above

Q72-Oxidation destroys many dosage form components types EXCEPT

A-Alcohols
B-Phenols
C-Alkaloids
D- suspension
E-cream

Q 73- Which of the following dosage form the drug will be more stable?
A- solution
B-emulsion
C- powder
D- Sugar

Written By Ph.Yousif Jawad

E- None of above

Q 74-Drug substances undergo preclinical testing for biologic activity to assess therapeutic activity
involve many scientist all but?
A-biologist
B-microbiologist
C- biochemist
D- geneticists
E-archeologist

Q75-Which one of the following terms is not included in the process and time from drug discovery to
approval for marketing?
A-phase I
B-phase II
C-phase III
D-phase VI
E-clinical trial

Q 76- Various techniques are used to determine crystal properties:

A-hot stage microscopy
B-thermal analysis
C-infrared spectroscopy
D-x ray diffraction
E-all of above

Q77- Which of the following terms is right regarding nitroglycerin storage container?
A- well-closed container
B- tightly sealed glass container
C- A hermetic container
D- Sterile hermetic containers
E-A single-dose container

Q 78-...................refers to a comparison of bioavailabilities of different formulations, drug products, or

batches of the same drug product.
A- Bioavailability
B- Biopharmaceutics

Written By Ph.Yousif Jawad

C- Bioequivalence
D-Pharmacokinetic
E-None of the above

Q 79- _________ is a prototype chemical compound that has a desired pharmacologic activity but may
not possess all of the properties desired
A- Monoclonal antibody
B-Lead compound
C- Orphan drug
D-Prodrug
E-Semisynthetic drug

Q 80-In embryotoxicity studies________is traditionally required for the studies

A-Rat
B-Mouse
C-Pig
D-Rabbit
E- Dog

Q81-To assist patients in taking their medications on schedule, manufacturers and pharmacists use -------
-----
A- Blister packaging
B-Package inserts
C-Compliance packaging
D- Labelling
E-Single unit packaging

Q 82-stability studies conducted in preformulation phase include:

A-solid-state stability of drug alone, then solution-phase stability, then stability in presence of excipients
B-solution-phase stability, then solid-state stability of drug alone, then stability in presence of excipients
D-solid-state stability of drug alone, then stability in presence of excipients, then solution-phase stability
C-solution-phase stability, then stability in presence of excipients, then solid-state stability of drug alone
E-stability in presence of excipients, then solid-state stability of drug alone, then solution-phase stability

Q83- Filters used in the manufacture of injectable drug products must:

A- not release fibers into the product

Written By Ph.Yousif Jawad

B- not cause drug release
C- not marketed
D- not pass quality control
E-be made of glass

Q84-For drugs intended to be given to humans for a week or more, animal studies of________________
__ must demonstrate safety
A- 90-180 days
B-1 year
C-2 weeks
D-30 days
E-18-24 months

Q85-If equivalent doses of drug in different formulations produce different AUC values this indicate:
what is the best answer?
A-differences exist in the extent of absorption
B-differences exist in the rate of absorption
C-differences exist in the extent of metabolism
D-differences exist in the rate of metabolism
E-differences exist in the extent of distribution

Q86-When drug product labeling containing "keep the product cool", means keep it at temperature:
what is the best answer?
A- 2 to 8 °C
B- -10 to -25°C
C- 8 to 15 °C
D- 20 to 25°C
E- 30 to 40 °C

Q87--all these features concerning goal drug are true EXCEPT:

A-Would produce the specifically desired effect
B-Exhibit low potency
C-Be pharmaceutically elegant
D-Physically and chemically stable under various conditions of use and storage
E-Have optimal onset and duration of activity

Q 88- Everted intestinal sac method is used for the evaluation of______________ of drugs

Written By Ph.Yousif Jawad

A- Distribution
B-Absorption

C-Metabolism
D-Excretion
E-Dissolution

Q 89-"-Efflorescent powders are those that may_____________

A-Absorb moisture from the air
B- Absorb moisture from the air and even liquefy
C-Give up their water of crystallization and may even become damp and pasty
D-Resistant to humidity
E- None of the above

Q90- Regarding preservative, choose the correct answer

A- elixirs, spirits, and tinctures require preservation addition
B-15% V/V alcohol will prevent microbial growth in alkaline media
C-intravenous preparations given in large volumes contain bacteriostatic additives
D-hydroalcoholic and most alcoholic preparations not require addition of preservative
E-molds and yeasts prefer alkaline medium while bacteria favoring slightly acidic medium

Q91- The value in the cross over experiment is that each individual serves as his own_______________
____by taking each of the products. Thus, inherent differences between individuals are minimize. Select
the most appropriate answer:
A-Standard
B-Blank
C-Control
D-Mean
E- Placebo

Q92-B12 is absorbed mainly by: what is the best answer?

A- passive diffusion
B-Facilitated passive diffusion
C- Active transport
D- Pinocytosis
E-Not absorbed

Written By Ph.Yousif Jawad

Q93- Ultraviolet absorbers may be added to plastic to: what is the best answer?
A- increase transmission of light
B-decrease transmission of light
C-sterilize the container
D-sterilize the drug content
E-sterilize the closure of the container

Q94- All liquid drugs can not be formulated as a tablet dosage form EXCEPT:
A-Amyl nitrate
B-Propylhexedrine
C-Nitroglycerin
D- Chloramphenicol
E-Diphenhydramine

Q95- The metabolism of drug into inactive product is___________

A- Irreversible process
B-Reversible process
C- Fast process
D- Always in the liver
E- Depend on the concentration of the drug

Q96- Regarding Biological characterization of the new drug. Biological characterization of the new drug
is important
A-To determination safety and usefulness of new drug.
B-undergoes in clinical testing to assess therapeutic activity
C-It needs only pharmacists to perform.
D-It needs only Biochemists to perform
E- None of the above

Q97- Regarding drug dose. Drugs are studied at various dose levels
A- to determine efficacy, safety and toxicity
B-to avoid harm the tested animal
C-to reduce the need for further studies
D-to determine the drug pharmacodynamics
E- All of the above

Q 98- Regarding drug discovery and drug design of genetic drugs.The basic technology that drives the
genetic field of drug development is:

Written By Ph.Yousif Jawad

A- Recombinant DNA
B-In vivo studies
C- Monoclonal antibody production
D- Options A & B
E-Options A & C,

Q 99-Regarding oral administration for infants and children younger than 5 years of age. All of the
following are true, EXCEPT:
A-Pharmaceutical liquids rather than solid forms are preferred.
B-The oral liquids may be flavored aqueous solutions, syrups, or suspensions.
C- The oral liquids administered directly into the infant's or child's mouth by drop, spoon, or oral
dispenser.
D- Single liquid pediatric preparation may not be used for infants and children with different ages.
E-The required dose of the drug may be incorporated into the child's food.

Q100- In drug development programs, preclinical drug safety evaluation or toxicity studies are
undertaken to determine all of the following parametrs, EXCEPT.
A- Bioavailability of the drug
B-The potential for toxicity with short-term or long-term use
C- The potential for specific organ toxicity
D-The mode, site, and degree of toxicity.
E-The substance's carcinogenic and genotoxic potential.

Q 101- Regarding the FDA regulations for finished pharmaceuticals. The regulations require that a
quality control unit have the authority and responsibility for all functions that may affect product
quality, which includes all of the following, EXCEPT.
A- The design of buildings and facilities
B-Accepting or rejecting product components
C-Product specifications
D- Finished products.
E- Packaging, and labeling

Q 102-Regarding flavouring excipients, the different types of flavours include:

A- Natural
B- Artificial
C- Spice
D- All of the above
E- None of the above

Written By Ph.Yousif Jawad

Q 103- According to Fick's first law The rate of diffusion or transport across a membrane (dc/dt) is
directly proportional to all of the following parameters, EXCEPT:
A-The concentration gradient between the two sides of the membrane
B-The thickness of the membrane
C- The permeability coefficient
D-The surface area of the membrane
E- The partition coefficient of drug

Q 104- Regarding bioavailability. An investigational drug is being developed for oral administration. The
drug is stable in gastrointestinal fluids and has good water solubility and membrane permeability. The
drug is a weak acid and has a pKa of 4.2. Studies in human volunteers found that the solution
formulation and suspension formulation of this drug had the same oral bioavailability. What can you
conclude from this finding?
A- Drug is passively absorbed
B-Drug dissolution is slow
C-Drug does not undergo first-pass metabolism
D- Drug dissolution is very rapid
E-Drug is passively absorbed and does not undergo first-pass metabolism

Q 105- Regarding cGMP standards and regulations. The majority of API synthesized in
A-UK
B-India
C-USA
D-Germany
E- France

‫ ما كدرت اكتبه الن ما موجود بالصورة بس تقريبا كم كلمة جانت موجودة بالصورة اللي هي ذني‬29 ‫ سؤال‬-: ‫مالحظة‬
Determining effect on gene / mutation / DNA damage using

‫هذني الكلمات بحثت عنها وطلعت موجودة بالجابتر اللي اسمه‬

New Drug Development and approval Process

Written By Ph.Yousif Jawad

 ‫وهاي صورة الساليد اللي بخصوص سؤال ‪29‬‬

‫‪Written By Ph.Yousif Jawad‬‬