BIOPHARMACEUTICS RED B.

stomach

1. This corresponds to the time required for C. duodenum

a drug to reach the a minimum effective
concentration (MEC) D. jejunum

A. onset of action E. colon

B. intensity 6. Which of the following can increase gastric

emptying rate?
C. duration od action
A. administration of metoclopramide
D. Cmax
B. vigorous exercise
E. AUC
C. cold beverages
2. It is the delivery of the active
pharmaceutical ingredients from a dosage D. lying in the left side
form into solution
E. consumption of high fat meal
A. Dissolution
7. Route of administration in which the drug
B. Absorption (in lotion, ointment, cream, paste, or patch) is
placed on the skin for systemic absorption
C. Liberation
A. Topical
D.Permeation
B. intracutaneous
D. Disposition
C. Transdermal
3. How much of a 500 mg dose is bioavailable
if the administered drug has F of 75% D. Buccal

A. 375 mg E. epidermal
B. 500 mg
C. 125 mg 8. Metered dose aerosols are examples of
D. d.50 mg which route of administration?
E. 5 mg
A. intranasal
4. Which of the following is the major process
of absorption for most drugs? B. inhalational
A. Passive Diffusion C. alveolar
B. Active transport D. peroral
C. Facilitated Diffusion E. respiratory
D. Vesicular transport CORRECT ANSWER:
E. Convective transport D. inhalational
5. For most drugs, which part of the 9. Which of the following routes of
gastrointestinal tract is the optimum site for administration has/have no first-pass effect
drug absorption after the oral administration?
I. buccal
A. Buccal cavity
II. sublingual
III. oral B. Disintegration

IV. rectal C. Solubility

A. I only D. Dissolution
B. II only
C. I & II E. Attrition
D. d.III only
E. I, II and IV 14. These products are the first ones to be
10. Which of the following is the plasma level patented or granted certain exclusivities
time curve of an open intravascular two-
A. generic medicines
compartment model
B. innovator products

C. multi source drug products

D. market leader

E. reference

15. Which of the following products are

considered to be pharmaceutical equivalents?

A. Mefenamic acid 250 mg cap &

11. If the AUC for the Phenobarbital mefenamic acid 500 mg cap
administered orally by tablet is 6.5 mcg/mL x
hr and the AUC for the Phenobarbital solution B. amlodipine besylate (innovator) 10
can give the same dose and route is 8.4 mg tab & amlodipine besylate
mcg/mL calculate the relative bioavailability of (generic) 10 mg tab
the drug.
C. amoxicillin 500 mg cap & amoxicillin
a. 129.23% d. 56. 38% 250 mg/mL susp.
b. 100% e. 43.62% D. Clindamycin HCl 300 mg cap &
clindamycin phosphate 150 mg/mL
c. 77.38% amp x 4 mL
12. This is the process by which a solid drug E. Paracetamol (Brand A) 500 mg tab &
substance becomes dissolved in a solvent paracetamol (Brand B) 500 mg cap
A. Liberation 16. Which of the following drug products are
considered to be pharmaceutical alternatives?
B. Disintegration
A. cephalexin 500 mg cap & cefalexin
C. Gastric Emptying
500 mg cap
D. Dissolution
B. propranolol 10 mg tab (branded) &
E. Dispersion propranolol 10 mg tab (unbranded)

13.For most conventional solid drug products, C. nifedipine 5 mg cap & nifedipine 20
which of the following is the rate limiting step mg mg GITS tab
for bioavailability?
D. ranitidine HCl (local) 150 mg tab &
A. Liberation ranitidine HCl (imported) 150 mg tab
17. This describes the passive diffusion of the C. pharmaceutical equivalence
drugs across the gastrointestinal blood barrier
D. therapeutic equivalence
A. Fick’s First law E. therapeutic substitution
21. A drug has high solubility but low
B. Noye’s-Whitney equation permeability may be classified based on the
Biopharmaceutics classification system as:
C. Henderson-Hasselbach Equation
A. Class 1
D. Clausius-Clapeyron Equation
B. Class 2
E. Raoult’s law
C. Class 3
18. Bioequivalence can be assessed using
which of the following methods? D. Class 4
I. in vivo pharmacokinetics studies involving E. Class 5
plasma or urine drug concentrations as a
function of time 22. Which of the following physicochemical
properties of a drug will result to a faster
II. In vivo pharmacodynamic studies dissolution rate?
III. Comparative clinical trials A. small surface area
B. unionized form
IV. Comparative in vitro studies C. high partition coefficient
D. amorphous form
A. a.I only
E. large particle size
B. b. I,II 23. in the BCS class the drug dissolves rapidly
and is well absorbed and bioavailability
C. c. III only problem is not expected for immediate-release
drug products
D. d. I to II
A. Class 1
E. e. I to IV
B. Class 2
19. Among the following oral drug formulation,
which is considered to be the most C. Class 3
bioavailable?
D. Class 4
A. Solution
E. Class 5
B. Suspension
24. Enteric coating used to:
C. Emulsion
I. mask the taste or odor of a drug
D. Powder
II. Minimize irritation of gastric mucosa by the
E. Granule drug

20. Dispensing ibuprofen instead of naproxen III. Protect the drug from moisture, light, air
is an example of:
IV. Prevent inactivation or degradation of the
A. generic dispensing drug in the stomach

B. pharmaceutical substitution V. delay the release of the drug until the

dosage from the reaches the small intestine,
where the condition for absorption may be A. Oral
optimal
B. Sublingual
A. I & II
C. Intravenous
B. II & IV
D. Subcutaneous
C. V only
E. intramuscular
D. II, IV & V
29. Which of the following is NOT an
E. I to V extended-release drug product?

25. This is an indication of the lipid solubility of A. sustained release capsule

a drug and its likelihood of being transported
across membrane. B. enteric-coated tablet

A. polymorphism C. slow-release tablet

B. permeability D. prolonged-action drug product

C. pH E. repeat-action tablet

D. pKa 30. This term is applied to a regulatory

approval process in which an application is
E. partition coefficient approved based on experience of equivalence
of a generic drug bioequivalence/in vivo
26. This refers to the systemic availability of a equivalence testing.
drug after extravascular administration
compared to IV dosing. A. dossier
B. abbreviated new drug application
A. bioavailability (ANDA)
C. in vivo-in vitro correlation (IVIVC)
B. bioequivalence D. biowaiver
E. e. clinical trials
C. relative bioavailability
31. This refers to the trade name of the drug
D. absolute bioavailability product which is privately qwned by the
manufacturer or distributor and is used to
E. therapeutic equivalence distinguish is the specific drug product from
those of competitors.
27. Parameters used to assess bioavailability/
biotaquivalence using plasma drug A. generic name
concentration
B. chemical name
A. tmax, Cmax
C. brand name
B. tmax, Cmax, AUC
D. market name
C. tmax, Emax
E. INN
D. t, Du
32. In the generalized plasma level time curve
E. t,Du dDu /dt shown below, which letter corresponds to the
intensity of action?
28.Drugs given by this route of administration
are considered to be 100% bioavailable
 CORRECT ANSWER:

B. Orange Book
In C
35. Which of the following methods is
used to determine AUC?

a. feathering d. analysis of variance

(ANOVA)

b. back-extrapolation e. two one sided

CORRECT ANSWER: test

C. c. trapezoidal rule

33. Pharmaceutical Equivalents are drug 36. Pharmaceutical alternatives are products
products that have the same that have the same

I. active pharmaceutical ingredients (API) I. active pharmaceutical ingredients (API)

II. Chemical form of the API II. chemical form of the API

III. Dosage form III. dosage form

IV. Dosage strength IV. dosage strength

V. route of administration V. route of administration

VI. Standards of identity, strength, quality and VI. standards of identity, strength, quality and
purity purity

A.I, II A.I only

B.II, III, IV B.III, IV, V

C.I, II, III C.I, III, IV

D.I to V D. I, V

E. I to VI E. I to IV

34. This reference identifies drug products 37.It refers to the unfinished dosage form that
approved on the basis of safety and contains the active drug ingrdient ,generally
effectiveness by the US FDA and contains ,but not necessarily ,in association with active
therapeutic equivalence evaluation for ingredients.
approved multisource prescription drug
products A. formulation

A. USP/NF B. therapeutic moiety

B. Orange book C. drug product

C. PNDF D. drug delivery system

D. Essential Drug list E. reference drug list

E. International pharmacopeia
38.In the given plasma-level time curve 41. It is the term used to describe the
below ,identify the letter that corresponds to accidental fast release of drug from a
the onset of action. sustained release dosage form

A. A A. liberation

B. B B. steady state

C. C I C. dose dumping

D.D D. flip flop model

E.E E. first pass effect

37. It refers to the finished dosage form that 42. This is the rate and extent to which the
contains the active drug ingredient generally, active pharmaceutical ingredient or active
but not necessarily in association with inactive moiety is absorbed from a drug product and
ingredients becomes available at the site of action

A. formulation A. area under the curve (AUC)

B. therapeutic moiety B. maximum plasma drug concentration

(Cmax)
C. drug product
C. bioavailability
D. Drug delivery system
D. bioequivalence
E. reference listed drug
E. therapeutic equivalence
39. This must be filed by generic drug
manufacture for approval to market a generic 43. This is a measure of the quantity of the
drug product drug in the body and ref;ects the total amount
of active drug that reaches the systemic
A. abbreviated new drug application circulation.
(ANDA)
A. area under the curve (AUC)
B. new drug application (NDA)
B. maximum plasma drug concentration
C. investigational new drug application (Cmax)
(INDA)
C. bioavailability
D. biowaiver
D. bioequivalence
E. BA/BE study
E. therapeutic equivalence
40. The processes of drug metabolism and
excretion constitute 44. This established when pharmaceutical
equivalents or alternatives display comparable
A. deposition bioavailabilities when studied under similar
experimental conditions
B. elimination
A. area under the curve (AUC)
C. accumulation
B. maximum plasma drug concentration
D. biotransformation (Cmax)
E. clearance C. bioavailability
 D. bioequivalence A. disintegration

E. therapeutic equivalence B. dissolution

C. permeation

45. Therapeutic equivalence is established D. gastric emptying

when the drug prosuct being compared are:
E. disaggregation
I. approved as safe and effective
49. Which of the following is NOT true?
II. pharmaceutical equivalents or alternatives
A. The amorphous form of the drug
III. bioequivalent generally dissolves faster

IV. manufactured in compliance to cGMP B. Polymorphs have the same chemical

structures and physical properties
IV. adequately labeled
C. Some excipients are intentionally
A.I only added to delay drug absorption
B.III only D. smaller particles size increases
dissolution rate
C.I, II, III
E. a basic drug is more soluble in an
D. I to IV acidic medium
E.I to V 50. The tmax of a drug refers to its time:
46 .To establish bioequivalence the calculated A. of the fastest dissolution
confidence interval should fail within the
usually prescribed limit of ___ for the ratio of B. to reach maximum drug concentration
the product averages
C. of highest solubility
A.50-100%
D. to reach maximum toxic concentration
B.90-110%
E. of maximum effectiveness
C.80-120%
51. In the LADMER system, R stands for?
D. 95-100%
A. Reabsorption D. Response
E. 80-125%
B. Recirculation E. Residence
47. Generally, two drug product formulations
whose rate and extent of absorption differ by C. Reactivation
__% or less are considered bioequivalent.
52. It is the study of how the physicochemical
A. 50 D. 20 properties of a drug, dosage forms and route
s of administration affect the rate and extent of
B.40 E. 10 drug absorption.
C. 30 A. LADMER system D. Biopharmaceutics
48. For drugs that have very poor aqueous B. Pharmaceutics E. Pharmacokinetics
solubility the rate limiting step on drug
bioavailability is: C. Physical Pharmacy
53. This is actual site of pharmacologic action C. Minimum effective
of drugs in the body concentration(MEC)

A. compartment D. cytosol D. Duration of action

B. biophase E. plasma E. Intensity

C. cell membrane 58. Example of a targeted drug delivery

system
54. Which of the following absorption
mechanism operate along concentration A. osmotic pumps
gradient?
B. enteric-coated tablets
I. passive diffusion II. Active transport
C. liposomes
III. facilitiated diffusion IV, vesicular transport
D. cyclodextrins
A.I only
E. implants
B.III only
59. This concept views the cell membrane as
C.I and III being composed of a non-rigid lipid matrix with
which are associated relatively mobile protein
D. II and IV masses that penetrate wholly or partially
through the lipid layer
E.I to IV
A. lipid bilayer model
55. This is the fraction of an administered
dose of a drug that reaches the systemic B. phospolipid matrix theory
circulation in the unchanged form.
C. lipoprotein compartment
A. bioavailable dose D. dumped dose
D. fluid mosaic
B. loading dose E. oral dose
E. unit membrane
C. maintenance dose
60. This refers to the ability of a drug to exixt
56. a 125 mg/mL drug suspension decompose in more than one crystalline form.
with a zero order rate constant of 0.5
mg/mL/hr. What is the concentration of the A. amphoterism
active drug remaining after 3 days
B. crystallization
A. 125 D. 89
C. polymorphism
B. 123.5 E. 62
D. ionization
C. 100
E. complexation
57.In the generalized plasma level –time
curve given below ,what corresponds to the 61. Dissolution rate differ for hydrated and
broken line E. anhydrous forms of a drug however, the most
usual situation is:
A. Maximum drug concentration
A. the anhydrous form dissolves faster
(Cmax)
B. the hydrated form dissolves faster
B. Onset of action
 C. the anhydrous and hydrated forms E. active ingredients
have equal dissolution rates
65. The LADMER system is essential in the :
D. the hydrated form has no effect on
dissolution A. development of dosage forms

E. the anhydrous form has no effect on B. determinations of pharmacokinetic

dissolution parameters

62. Equivalence are not necessary for which C. evaluation of bioavailability

of the following products
D. adjustment of dosage regimen
I. Parenteral aqueous solution
E. all of the given choices
II. Pharmaceutically equivalent oral solutions
66. This is the most common and popular
III. pharmaceutically equivalents topical route of the drug administration
solutions
A. oral
IV. products containing drugs with narrow
therapeutic indices B. parenteral

A. I only C. rectal

B. IV only D. buccal

C. II and III E. topical

D. I to III 67. Which of the following is NOT an enteral

route of drug administration
E. I to IV
A. sublingual
63. Which of the following transport
mechanism does not require a drug to be in B. buccal
aqueous solution in order to be absorbed?
C. rectal
A. passive diffusion
D. Peroral
B. convective transport
E. None of the previous choices
C. carrier mediated transport
68. Which of the following compounds may be
D. ion transport absorbed via convective transport?

E. vesicular transport A. Vitamin B12

64. These are added to a formulation to B. inorganic and organic electrolytes with
provide certain functional properties to the molecular weights up to 400
drug and dosage form
C. most weal organic acids and bases
A. prodrugs
D. fats
B. xenobiotics
E. quaternary ammonium compounds
C. probiotics
69. Determine the half-life of an
D. excipients antihypertensive drug if it appears to be
eliminated from the body at a rate constant of D. III and IV
0.07 hour. Assume first order kinetics occurs.
E. I to IV
A. 12
73. The drug is injected into the spinal fluid
B. 9.9
A. intraarticular
C. 7
B. epidural
D. 4
C. Intracranial
E. 1.5
D. Intrathecal
70. Which of the following statements is NOT
true? E. intrasynovial

A. a cell membrane is a semi permeable 74. Which of the following is NOT a

structure composed of lipids and characteristic of active transport?
proteins
A. drug moves along concentration
B. Drugs bound to protein do not easily
cross cell membranes B. process requires expenditure of
energy
C. Ionic or polar, water- soluble drugs
cross cell membrane more easily than C. requires a carrier
do nonpolar, lipid soluble drugs.
D. saturable at high drug concentration
D. low molecular weights drugs diffuse
E. process is subject to competition
across cell membrane more easily
than do high molecular weight drugs 75. These are addition compounds of drugs
and organic solvents
E. drugs may transported by passive
diffusion, carrier-mediated, A. hydrates
paracellular or vesicular transports
B. solvates
71. Most drugs are:
C. polymorphs
A. strong electrolytes
D. clathrates
B. non electrolytes
E. chelates
C. weak acids
76. Which of the following statements is false?
D. weak bases
A. In general, salts of electrolytes
E. C and D dissolve faster than the free acids or
bases
72. Which of the following is/are forms of
vesicular transport that differ by the type of B. the most stable polymorphs has the
material ingested? lowest dissolution rate
A. I only C. Increasing amounts of binders in
grabukes and tablets prolong
B. III only
dissolution time.
C. I and II
 D. Increasing amounts of lubricants A. peroral
shortens dissolution time
B. sublingual
E. particle size reduction is not a
universal answer to all drugs of low C. parenteral
solubility
D. Rectal
77. The enormous surface are of the
gastrointestinal tract is due to presence of: E. transdermal

A. enzymes 81. Type of parenteral administration in which

the drug is injected slowly into the plasma at a
B. microvilli constant or zero-order rate

C. parietal cells A. IV push

D. tight junctions B. IV bolus

E. gastric pits C. IV infusion

78. In oral drug administration, the drug is D. IM

swallowed undergoes absorption from the
gastrointestinal tract through the mesenteric E. SQ
circulation to the ___ into the liver and then to
82. The pharmacological effect of a drug
the systemic circulation
depends on the percentage of receptors
A. hepatic portal vein occupied

B. biliary duct A. Lock and key hypothesis

C. aorta B. Hypothesis of paton

D. jugular vein C. Hypotheses of Ariens and Stephenson

E. superior vena cava D. Hypothesis of clark

79. A condition in which the rate of drug E. Occupation theory

leaving the body is equal to the rate of drug
83. the drug molecules is bound to the surface
entering the body.
of the skin or mucosa by ion-binding,
A. double-peak phenomenon hydrogen-binding or van der waals forces:

B. flip-flop model a. absorption

C. first-pass effect b. penetration

D. steady state c. Adsorption

E. therapeutic window d.Permeation

80. The route of drug administration that is e. leaching

preffered when rapid absorption is essential,
84. It describes the diffusion-controlled rate of
when patients are inconscious or unable to
drug dissolution
accept medications by mouth or when drugs
are destroted, inactivated or poorly absorbed A. Henderson-hasselbach equation
in the GIT.
 B. fick’s law of diffusion a. onset d. therapeutic window

C. Michaelis-menten equation b. intensity e.area under the curve(AUC)

D. Noyes-whitney equation c. duration of action

E. Van slyke’s equation 90. This refers to the drug concentration range
between the minimum effective concentration
85. which of the following parameters will (MEC) and the minimum toxic concentration
determine the degree of drug ionizations? (MTC)
I. lipid/ water coefficient of the drug a. onset
II. pH at the absorption rate b. intensity
III. pKa of the drug c. duration of action
A. I only d. therapeutic window
B. I and II e. area under curve
C. I and III 91. This describes the relationship between
the ionized and the nonionized forms of a
D. II and III drug as a function of pH and pKa.
E. I,II and III a. Law of Multiple proportions
86. What is the minimum percent of drug that b. Nernst Distribution Law
must be in the nonionized form at the small
intestine in order to be absorbed via passive c. Henderson-Hasselbach equation
diffusion
d. common-ion effect
a. 0.1% to 1% d. 50% to 60%
e. partition coefficient
b. 1 to 5% e. 80% to 90%
92. Which of the following is a common site
c. 10 to 20% for IM injection?
87. The partition coefficient is a/an: a. gluteus medius
A. in vitro guide to the absorption b. thigh e. ebdomen
potential of a drug
c. Gastrocnemius
B. measure of the relative affinity of a
drug for two immiscible phases d. gluteus maximus

C. indicator for storage of drugs in fat e. abdomen

D. parameter of the relative rate of 93. It refers to the time for which the drug
partitioning from one phase into concentration remains above the minimum
another effective concentration (MEC)

E. all of the given choices a. duration of action d. Cmax

88. This is the time from drug administration to b. intensity e. onset

reach the minimum effective concentration
(MEC) c. tmax
94. Which of the following oil phases is most C. diffusion layer
commonly used in partition coefficient
determination? 100. Order reaction in which the concentration
of a drug is decreasing at a rate that is
a. chloroform d. mineral oil proportional to the concentration of the drug
remaining:
b. cyclohexane e. octanol
A. zero D. third
c. isopropyl myristate
B. first E. fourth
95. Maximum volume to be injected via the
intramuscular route: C. second

a. 0.5 mL d. 5 mL 101. Facilitated diffusion is similar to active

transport since it:
b. 1 mL e. 10 mL
A. operates against concentration
c. 2 mL gradient
96. This is the dose used in initiating therapy B. utilizes energy in the form of ATP
so as to yield therapeutic concentration which
will result in clinical effectiveness C. is carrier mediated

A. daily dose D. loading dose D. None of the choices

B. First dose E. effective dose E. all of the given choices

C. prophylactic dose 102. Decreased particle size results to:

97. This is the dose required to maintain the A. increased particle surface area
clinical effectiveness or therapeutic
concentration according to the dosage B. enhanced water penetration into particles
regimen.
C. increased dissolution rate
A. therapeutic dose D. priming dose
D. none of the choices
B. maintenance dose E. effective dose
E. all of the above
C. steady-state dose
103. When drug is half ionized and half
98. Cmax represents the maximum drug nonionized at a certain pH, its pKa is:
concentration obtained after oral
administration of a drug in the: A. greater than pH

A. plasma D.feces B. less than pH

B. urine E. sweat C. equal to pH

C. saliva D. of no value

99. This is an entity which can be described E. constant

by a definite volume and a concentration of
104. This is obtained when the drug product is
drug contained in that volume
administered at the site where the
A. biophase D. compartment pharmacological response is desired and
when the drug released from the products
B. bulk phase E. depot phase
acts by adsorption to the skin or mucosa, but I. kidneys
does not enter the systemic blood circulations
II. Liver
A. systemic effect
III. Small intestines
B. local effect
A. I only
C. therapeutic response
B. II only
D. Biological response
C. III only
E. dermal effect
D. I and II
105. This is obtained when the drug released
the drug product enters the bloodstream and E. I and III
is distributed within the body regardless of the
site and route of administration 109. The form of the drug that is absorbed:

A. systemic effect I. nonionized

B. local effect II. Ionized

C. therapeutic effect III. lipid-soluble

D. biological response IV. Water-soluble

E. dermal effect a. I only

106. This is the process with the slowest rate b. II only

constant in a system of simultaneous kinetic
c. I and III
processes.
d. II and IV
A. zero-order kinetics
e. I to IV
B. first-order kinetics
110. What is the % of ionized species of a
C. half-life
weak acid with a pKa of 4.2 in a urine pH of
D. rate-limiting step 6.2?

E. clearance a. 0.1

107. These are inactive substances that must b. 1

be biotransformed in the body to metabolites
c. 10
that have pharmacologic activity
d. 90
A. xenobiotics
e. 99
B. lead compounds
111. Which of the following is devoid of
C. prodrugs
clotting proteins?
D. therapeutic moieties
A. blood
E. orphan drugs B. plasma

108. Reabsorption of drugs can occur in the C. serum

 D. both B and C A. humectants

E. all of the given choices B. emollients

112. Drug entering the body does not instantly C. sorption promoters
distribute between the blood and those other
body fluids or tissues which it eventually D. wetting agents
reaches
E. solubilizers
A. open one-compartment model
117. Absorption mechanism in which drug
B. open two-compartment model molecules dissolved in aqueous medium at
the absorption site move along with the
C. multi-million compartment model solvent through membrane pores:

D. central compartment A. passive diffusion

E. peripheral compartment B. active transport

113. According to the Fick’s Law, the rate of C. facilitated diffusion

diffusion of a drug is:
D. convective transport
A. independent of the concentration
gradient E. ion-pair transport

B. inversely proportional to the surface 118. Which of the following absorption

area of the membrane mechanisms operate(s) against concentration
gradient?
C. inversely proportional to the
membrane thickness I. passive diffusion

D. inversely proportional to the partition II. Facilitated diffusion

coefficient of the drug
III. Active transport
E. independent of the diffusion coefficient
of the drug A. I only

115. Highly lipid soluble drugs are B. II only

predominantly distributed in which of the
C. III only
following tissues?
D. I and II
A. bone
E. II and III
B. adipose
119. Rate constants in pharmacokinetics are
C. muscle
usually:
D. hepatic
A. zero-order
E. renal
B. first-order
116. These are substances that have no
C. second-order
pharmacological properties of their own in the
concentration used, but which can improve D. third-order
the penetration of drugs into the skin or
mucosa. E. fourth-order
120. Cyancobalamin is a classical example of A. 36
a drug that is absorbed via:
B. 20
A. convective transport
C. 16
B. facilitated diffusion
D. 9
C. vesicular transport
E. 0.11
D. passive diffusion
124. These are drugs in which the
E. ion-pair transport pharmacological action is not directly
dependent on the chemical structure of the
121. Which of the following is the correct rank drug.
order (from the most bioavailable to the least)
for the given conventional oral formulations? A. structural nonspecific drugs

A. coated tablet> uncoated tablet> B. structural specific drugs

capsule> suspension> solution
C. drug-receptor complexes
B. solution> suspension> capsule>
coated tablet> uncoated tablet D. ligands

C. suspension> solution> uncoated E. substrates

tablet> coated tablet> capsule
125. If the volume of distribution of a drug in
D. solution> suspension> capsule> an adult is approximately 5L, it means that the
uncoated tablet> coated tablet drug is confines to the:

E. capsule> uncoated tablet> coated A. circulatory system

tablet> solution> suspension
B. extracellular fluid
122. Excipients are added to product
formulations to: C. intracellular fluid

A. facilitate preparation D. whole body fluid

B. improve patient acceptability of the E. deep tissues

product
126. Surfactants are used: in dosage forms
C. improve functioning of the dosage as:
form as a drug delivery system
A. emulsifying agents
D. all of the choices
B. solubilizing agents
E. none of the choices
C. suspending agnets
123. An aqueous phase (pH 7.4 buffer)
D. wetting agents
containing a drug, was shaken with an oil
phase (octanol) and the mixture was then left E. all of the given choices
to reach equilibrium. The two phases were the
separated and the concentration of the drug in 127. Which of the following is/are technique/s
each phase was measured. The resulting used to increase the aqueous solubility of
values were as follows: C octanol = 18; C poorly water-soluble drugs?
buffer = 2. Based from the results, calculate
the partition coefficient of the drug. A. cosolvency
 B. complex formation II. In C= -kt + In C0

C. solubilization III. log C = -(k/2.3)t + log C0

D. all of the choices IV. C = C0e –kt

E. none of the choices A. I only

128. Which of the following is/are the effect/s B. II only

of food on the bioavailability of a drug from a
drug product? C. III only

A. delay in gastric emptying D. II to IV

B. stimulation of bile flow E. I to IV

C. physical or chemical interaction of the 132. The half-life of a given drug is 6 hours.
meal with the drug product or drug How many half-lives have passed 24 hours
substance after administration?

D. a change in the pH of the GIT A. 24

E. all of the given choices B. 12

129. In passive diffusion, the term passive C. 10

pertains to what characteristic of this
absorption mechanism? D. 6

A. moves along concentration gradient E. 4

B. a carrier mediated process 133. Which of the following is NOT an

extravascular route of drug administration?
C. does not require the expenditure of
energy I. oral

D. is subject to competition II. rectal

E. has saturation point III. intramuscular

130. This is the loss of drug from the central IV. subcutaneous
compartment due to transfer into other
V. intravenous
compartments and/or elimination
A. I only
A. absorption
B. V only
B. distribution
C. I and II
C. penetration
D. III to V
D. disposition
E. II to V
E. permeation
134. Which of the following processes occurs
131. Which of the following is/are the
mostly in the proximal convoluted tubule
equation/s of a first-order reaction?
(PCT)?
I. C= -k0 t + C0
A. glomerular infiltration
 B. tubular secretion of 8.2 mcg/mL. Calculate the volume of
distribution in liters(L).
C. tubular reabsorption
A. 36.6
D. both B and C
B. 27.3
E. all of the given choices
C. 20.5
135. In order to excrete amphetamine more
quickly in the urine, which of the following may D. 10.6
be used intravenously?
E. 8.7
A. urinary acidifier
139. The peripheral compartment is
B. urinary alkanizer subdivided into:

C. inulin A. central compartment

D. creatinine B. shallow compartment

E. all of the choices C. deep compartment

136. If the AUC for an oral dose of a drug D. both A and B

administered by tablet is 4.5 mcg/mL/hr, and
the intravenous dose is 11.2 mcg/mL/hr, E. both B and C
calculate the absolute bioavailability (in %) of
the oral dose of the drug. 140. The bioavailability of a new
investigational drug was studied in 24
A. 2.5 volunteers. Each volunteer received either a
single oral tablet (200mg), 5ml of a pure
B. 10 aqueous solution (200mg) or a single IV bolus
injection (50mg). The average AUC values are
C. 15 given below. From these data, calculate the
absolute bioavailability of the drug.
D. 40
104%
E. 62
A. 59.2%
137. The normal glomerular filtration rate
(GFR) is: B. 56.9%
A. 125-130 mL/min C. 42.2%
B. 90-100 mL/min D. 23.6%
C. 60-90 mL/min 141. If the volume of distribution exceeds the
body weight, it is assumed that the drug is:
D. 30-59 mL/min
A. stored in body fat
E. ,15 mL/min
B. bound to body tissues

C. distributed to deep tissues in

138. A patient received a single intravenous peripheral compartments
dose of 300mg of a drug substance that
produced an immediate blood concentration D. A and B
 E. all of the above 146. Which of the following is/are eliminated in
the body solely by filtration?
142. If the half-life for decomposition of a drug
is 12 hours, compute for the first-order rate A. inulin
constant.
B. creatinine
A. 0.693/hr
C. electrolytes
B. 0.510/hr
D. both A and B
C. 0.267/hr
E. both B and C
D. 0.058/hr
147. A solution of a drug was freshly prepared
E. 0.012/hr at a concentration of 300mg/ml. After 30 days
at 25°C, the drug concentration in the solution
143. Vegetables and fruits, and diets rich in was 75mg/mL. Assuming first-order kinetics,
carbohydrates result to a/an: when will the drug decline to one-half of the
original concentration?
A. decrease in urinary pH
A. 0.046 day
B. increase in urinary pH
B. 0.5 day
C. increase GFR
C. 7 days
D. decrease GFR
D. 10 days
E. none of the choices
E. 15 days
144. The central compartment refers to the:

A. body fluids or tissues into which the

drug distributes slowly 148. This concept in pharmacokinetics is a
hypothetical structure which can be used to
B. compartment that is not accessible by characterize with reproducibility, the behavior
blood sampling and the fate of a drug in biological systems
when given by a certain route of
C. body fluids or tissues which are in
administration and in a particular dosage
equilibrium with the circulatory system
form.
D. both A and B
A. biophase
E. both B and C
B. compartment
145. The differences in bioavailabilities of drug
C. model
products may be due to:
D. order
A. physiological factors
E. rate constant
B. drug factors
149. If the bioavailability of digoxin in a
C. dosage from design
0.25-mg tablet is 0.60 compared to the
D. both B and C bioavailability of 0.75 in a digoxin elixir
(0.05mg/mL), calculate the dose (in mL) of the
E. all of the given choices elixir equivalent to the tablet.

A. 0.0375
 B. 0.15 C. Fick’s
C. 0.5 D. Hess
D. 3 E. NOTA
E. 4 154. Cyanocobalamine can be absorbed
through this transport mechanism.
150. The concentration of a drug remaining
after 180 min was 5mg/dL from an initial conc. A. Passive Diffusion
of 60mg/dL. Compute for the first-order rate
constant. B. Convective

A. 0.001/min C. Active

B. 0.02/min D. Facilitated

C. 0.0138/min E. Ion pair

D. 0.693/min 155. It refers to the net transfer of a drug from

the circulating fluids of the body to various
E. 0.05/min tissues and organs.
151. In IV infusion, it is essential to administer A. Absorption
the dose in order to immediately reach the B. Distribution
steady state.
C. Metabolism
A. Loading dose
D. Excretion
B. Maintainance dose
E. NOTA
C. Titered dose
156. This refers to the extent of fraction of
D. Priming dose drug absorbed upon extravascular
administration in comparison to the dose size
E. Choices A and D administered.
152. This is the dose used in initiating therapy A. Relative bioavailabilty
so as to yield therapeutic concentration which
will result in clinical effectiveness. B. Absolute Bioavailability
A. Loading dose C. Pharmacokinetics
B. Priming dose D. Biopharmaceutics
C. Initial dose E. NOTA
D. Choices A,B or C 157. This method to estimate the area under
the curve is used if no curve fitting has been
E. NOTA done for a set of blood level curve is not
smooth if no pharmacokinetic data have been
153. Passive diffusion follows
determined.
A. Noyes Whitney
A. Counting rule
B. Graham’s
B. Weighing rule
 C. Trapezoidal rule D. Choices A and B

D. Jelliffe Rule E. AOTA

E. Crock’s Rule 162. This refers to the anatomical location of

the receptors for a drug.
158. These processes are collectively referred
to as elimination. A. Enzymes

A. Absorption B. Proenzyme

B. Metabolism C. Biotrans

C. Excretion D. Biophase

D. Choices A and B E. Microsomes

E. Choices B and C 163. This refers to the hypothetical volume of

distribution in mL of the unmetabolized drug
159. This is the sum of all body regions in which is cleared per unit of time by any
which the drug concentration is in pathway of drug removal
instantaneous equlibrium with that in blood or
plasma. A. Volume of Distribution

A. Central Compartment B. Clearance

B. Peripheral Compartment C. Concentration gradient

C. Compartment D. Half-life

D. Tissues E. Absorption

E. System 164. Albumin concentration is reduced in

newborns and infants.This may result in
160. This type of intravenous administration ______volume of distribution and______in
can be considered as multiple dosing with free drug concentration in plasma
infinitely small dosing intervals.
A. Increased,decreased
A. IV bolus
B. Decreased,increased
B. IV infusion
C. Increased,increased
C. IV Bolus(Multiple dose)
D. Decreased,decreased
D. IV push
E. NOTA
E. NOTA
165. Half-life depends on
161. These processes are collectively called
disposition A. Volume of distribution

A. Distribution B. Clearance

B. Metabolism C. Absorption rate

C. Excretion D. Choices A and B

 E. Choices B and C E. Fraction distributed

166. In clinical terms ,it is defined as the 170. This is a term used to describe the
millimeters of blood cleared of drug per minute achievement of sustained drug concentration
by simply increasing the dose size or by
A. Absorption accidental fast release of drug from a
sustained release dosage form
B. Half-life
A. Dose Curve
C. Volume of distribution
B. Accumulation
D. Clearance
C. Dose Dumping
E. NOTA
D. Dose Dependency
167. The enzyme capacity in newborns and
infants is reduced.Hence,drugs being E. Dose Attrition
metabolized exhibit usually _____elimination
half-life and_____clearance. 171. This is the first step in oral absorption
process
A. Increased,decreased
A. Drug enters the systemic circulation
B. Decreased,increased
B. Drug dissolved in the intestinal fluid
C. Increased,increased
C. Drug crosses the epithelial tissues of
D. Decreased,decreased the GI tract
E. NOTA D. Drug crosses the hepatoportal system
168. In intravenous multiple dose E. Drug enters the inferior vena cava
administraton ,the longer the elimination half-
life and the shorter the dosing interval. 172. A drug is considered completely when
absorbed when
A. the lower will be the accumulation
A. Drug enters the systemic circulation
B. the faster will be the accumulation
B. Drug dissolved in the intestinal fluid
C. the slower will be the accumulation
C. Drug crosses the epithelial tissues of
D. the higher will be the accumulation the GI tract
E. NOTA D. Drug crosses the hepatoportal system
169. This can be determined from E. Drug enters the inferior vena cava
experiments in which a subject is given the
same dose bolus IV dose and an oral dose 173.This is a phenomenon in which the drug
and the ratio of the AUC of the two is is completely subjected to liver metabolism
calculated
A. Pre-systemic metabolism
A. Fraction dissolved
B. First pass effect
B. Fraction expelled
C. Enterohepatic recycling
C. Fraction absorbed
D. Choices A and B
D. Fraction excreted
 E. Choices B and C E. Narrow therapeutic index

174. This refers to the time in hours necessary 178. Why do pharmacokineticists measure
to reduce the drug concentration in the blood, drug levels?
plasma , or serum to one-half equilibrium is
reached A. Design of a dosage regimen

A. Half-life B. Maintain drug at optimum drug levels

B. Clearance C. Confirm patient compliance

C. Elimination D. AOTA

D. Hepatic Clearance E. NOTA

E. Gastric Emptying 179. Drug levels are measured at this time

period to assess the current therapy
175. This is used to describe the process of
taking drug concentrations ,basic A. Minimum therapeutic concentration
,pharmacokinetic principles , and the person’s
clinical response and combining them to B. Maxinum toxic cocentration
optimize drug therapy for the patient
C. Steady State Level
A. Clinical Pharmacokinetics
D. AOTA
B. Therapeutic Drug Monitoring
E. NOTA
C. Applied Pharmacokinetics
180. This is the final elimination of a drug from
D. AOTA the body’s systemic circulation via the kidney
into urine ,via bile and saliva into the
E. NOTA intestines,and into feces,via sweat,skin,and
milk.
176. At steady state ,the longer the elimination
half-life and the shorter the dosing interval, A. Enterohepatic recycling

A. the less will be the fluctuation B. Metabolism

B. the higher will be the fluctuation C. Excretion

C. the more will be the fluctuation D. Urination

D. Choices B and C E. Clearance

E. NOTA 181. These are usually measured if a drug is

given by extravascular administration or
177. Blood level determinations are done intermittent infusion and it demonstrates a
when a medication has a significant difference in concentration before
end after dosing.
A. Toxicity
A. Peak concentration
B. Adverse effects
B. Trough concentration
C. Side effects
C. Steady State concentration
D. Therapeutic failure
D. Choices A and B
 E. AOTA hydrophilic compounds is_____ and that of
lipophilic ones is_____
182. This is the increase in enzyme content or
rate of enzymatic processes resulting in faster A. Increased, decreased
metabolism of a compound.
B. Decreased, increased
A. Enzyme Restriction
C. Increased, increased
B. Enzyme Inhibition
D. Decreased, decreased
C. Enzyme Imbibition
E. NOTA
D. Enzyme Induction
187. If a drug stimulates its own metabolism.it
E. Enzyme Coagulation is called

183. The peak for an intravenous bolus dose A. Oxidation

would be obtained.
B. Reduction
A. Immediately after the dose is given
C. Auto oxidation
B. Right after the infusion stops
D. Auto induction
C. After the distribution
E. Enzyme Inhibition
D. After the elimination phase
188. This refers to a graphical method for
E. NOTA separation of exponents such as separating
the absorption rate constant from the
184. The peak concentration following an IV elimination rate constant.
infusion of a drug usually occur
A. Residual Method
A. Immediately after the dose is given
B. Feathering
B. Right after the dose stops
C. Interpolation
C. After the distribution phase
D. Extrapolation
D. After the elimination phase
E. Choices A and B
E. NOTA
189. This is the most frequently used assay
185. Drug concentrations are obtained by method for therapeutic drug monitoring.
A. Venipuncture of the venous blood A. Radioimmunoassay
B. Venous of arterial blood B. Gas Chromatography
C. Venipuncture of jugular blood C. Microbiological assay
D. Choices A and B D. Enzyme multiplied immunoassay
E. Choices B and C E. NOTA
186. The larger amount of total body fluid and 190. It is the sum of all chemical reactions for
the very small amount of fat tissue in infants biotransformation of endogenous and
make it likely that the volume of distribution of
exogenous substances which take place in 194. This is observed upon topical or rectal
the living cell route of administration where the absorption is
slower than the elimination.
A. Absorption
A. Flip-Stock Model
B. Elimination
B. Flip-Top Model
C. Metabolism
C. Flip-Flop Model
D. Excretion
D. Flip-Stop Model
E. Clearance
E. Flip-Stoop Model
191. It can be determined using a person’s
weight in kilograms and height in centimeterss 195. It is a measure of the rate and extent of
drug absorption
A. Creatinine clearance
A. Cmax
B. Lean Body weight
B. AUC
C. Average Body weight
C. BA
D. Body Surface Area
D. F
E. NOTA
E. Ka
192. It is the lowest concentration of a drug
that arrests or inhibits the growth of a bacteria 196. Determinations which can directly the
rate and extent of absorption
A. Maximum inhibitory concentration
A. F
B. Minimum inhibitory concentration
B. Ka
C. Minimum effective concentration
C. AUC
D. Minimum therapeutic concentration
D. Choices A and B
E. Maximum therapeutic concentration
E. Choices B and C
193. This refers to a change of one or more of
the pharmacokinetic parameters during 197. The FDA lists these products if they
absorption,metabolism and excretion by pharmaceutical equivalents that are
saturation or overloading of processes due to bioequivalent
increase dose size.
A. Pharmaceutical Equivalents
A. Saturation kinetics
B. Pharmaceutical alternatives
B. Non-linear kinetics
C. Bioequivalent drug products
C. Linear kinetics
D. Therapeutic equivalents
D. First pass effect
E. Ion pair
E. Choices A and B
198. This transport mechanism is formed
through the complex of an organic anion of a
substance with a cation of medium or 202. This measure of creatinine can be
membrane expressed directly by measuring urine output
for 24hours and dividing this volume by
A. Passive diffusion measurement of serum creatinine drawn at
the midpoint of the 24-hour collection period
B. Convective transport
A. Hepatic clearance
C. Active
B. Nephrotic clearance
D. Facilitated
C. Creatinine clearance
E. Ion pair
D. Clearance
199. The transport mechanism happens
against concentration and electrochemical E. Cockcroft and Gault
potential
203. This transport mechanism is mediated by
A. Passive diffusion means of carriers under expenditure of energy
and along a concentration gradient.
B. Convective transport
A. Passive diffusion
C. Active
B. Convective
D. Facilitated
C. Active
E. Ion pair
D. Facilitated
200. This term compares the extent of
absorption of a test product (i.e.,generic)to a 204. Vitamins A, D, E and K can be
standard or reference product,which is often transported via the mechanism
an oral solution or an immediate-release
tablet ,but not an IV product. A. Pinocytosis

A. Absolute Bioavailability B. Active

B. Relative Bioavailability C. Passive Diffusion

C. Intermediate Bioavailability D. Facilitated

D. AOTA E. Ion Pair

E. NOTA 205. This equation allows the determination of

the differences in creatinine clearance based
201. This principle states that the on patients’ weight ,age and gender
concentration of the drug remainingin the
body at any time is added to the concentration A. Jellife
remaining from the previous dose
B. Cockcroft and Gault
A. Multiple dosing
C. Noyes Whitney
B. IV Bolus
D. Fick’s
C. Superposition
E. NOTA
D. Exponentiation
206. This is a result of saturation of a
E. Potentiation metabolic carrier mediated system because
the enzyme involved in the metabolic process 210. In the treatment design ,both an active
can no longer and a placebo are given to the same subject

Accept drug resulting in an increase in plasma A. Time series design

drug concentration and possible toxicity
B. Cohort
A. Linear pharmacokinetics
C. Crossover
B. Nonlinear pharmacokinetics
D. Placebo
C. Saturated pharmacokinetics
E. Causal
D. Unsaturated pharmacokinetics
211.If rats were the most sensitive species
E. NOTA ,the starting dose for human acute dose
tolerance study would be________of the
207. The primary goal of Phase 1 in drug largest no-observable-effect dose (mg/kg)from
development the chronic rat toxicity study
A. Safety of the drug candidate A. One-third
B. Efficacy of the drug candidate B. One-sixth
C. Quality of the drug candidate C. One-eight
D. Stability of the drug candidate D. One-tenth
E. AOTA E. One-sixteenth
208. The initial administration of an 212. If the dogs were the most sensitive
investigational new drug to humans is usually species, the starting dose for human acute
accomplished in dose tolerance study would be ________of
the largest no-observable-effect dose (mg/kg)
A. Patients from the chronic rat toxicity study
B. Healthy subjects A. One-third
C. Rodents B. One-sixth
D. Choices A and B C. One-eight
E. Choices B and C D. One-tenth
209. It is the only transport mechanism in E. One-sixteenth
which the drug or compound does not have to
be in aqueous solution in order to be 212. If nonhuman primate were the most
absorbed sensitive species, the starting dose for human
acute dose tolerance study would be
A. Endocytosis ________of the largest no-observable-effect
dose (mg/kg) from the chronic rat toxicity
B. Passive diffusion
study
C. Active
A. One-third
D. Facilitated
B. One-sixth
E. Ion pair
C. One-eight
 D. One-tenth 221. This part of Phase II clinical trial proves
whether a drug works in patients
E. One-sixteenth
A. Phase IIa
214. The blood level time curve should have
at least hoe many blood level points during B. Phase IIb
the absorptive phase?
C. Phase IIIc
A. 2
D. Phase IVd
B. 3
E. NOTA
C. 4
222. This part of Phase II clinical trial
D. 5 determines the best dose ,dose range,
titration, scheme, and dose interval.
E. 6
A. Phase IIa
218. In phase 1 clinical trial the occurrence
of a dose limiting adverse event can be B. Phase IIb
grounds for
A. Discontinuing the volunteer C. Phase IIIc

B. Terminating the study D. Phase IVd

C. Increasing sample size E. NOTA

D. Decreasing sample size 223. It is an increase in drug effect over time

despte constant drug concentrations at the
E. Choices B and D effect site,which is manifested by a
counterclockwise hysteresis loop of plot of
219. These are sources of pharmacokinetic effect vs.concentraton
variability, EXCEPT
A. Tolerance
A. Saturable first pass metabolism
B. Threshold
B. Diurnal variation
C. Sensitization
C. Autoinduction
D. Downregulation
D. Genetic polymorphism
E. Side effect
E. NOTA
224. The following are performed in phase II
220. These studies are the first to include clinical trials, EXCEPT
patients with the disease intended for
treatment A. Reproductive toxicology

A. Phase I B. Placental transfer

B. Phase II C. carcinogenicity

C. Phase III D. Mass balance studies

D. Phase IV E. NOTA

E. NOTA
225. For the determination of current C. Caco-2
pharmacokinetic parameters from blood level
curves, sampling should be continued for at D. PAMPA
least how many elimination half-lives?
E. Mast cells
A. 2
229. This cultured line allows for
B. 3 characterization of mucosal to serosal and
serosal to mucosal transport and can b=e
C. 4 used to study transcellular and paracellular
transport
D. 5
A. HT-29
E. 6
B. T84
226. This cultured cell model to predict drug
absorption is capable of secreting mucin,the C. Caco-2
primary agent of the mucous barrier in the
intestinal mucosa. D. PAMPA

A. HT-29 E. Mast cells

B. T84 230. In this method to evaluate the transport

of drugs ,a small section of intestinal mucosa
C. Caco-2 is sandwiched between two chambers
containing buffer.
D. PAMPA
A. Clinical safety
E. Mast cells
B. Clinical efficacy
227.This computer simulation aids in the
identification of optimal dosage C. Clinical outcome
regimen,evaluation of effective PK/PD models
,placebo response ,disease progression D. Clinical surrogate
,adverse effect development ,and ultimately
,the expedition of the decision making, E. Clinical identity
regulatory review ,and commercialization of
232. For this particular [hase in the drug
new drug processes.
development ,the drug candidate is tested
A. Computer-aided clinical trial design under conditions and in patients more closely
resembling those who would be encountered
B. GastroPlus if the drug were approved

C. PK/PD Modelling A. Phase I

D. GC-MS B. Phase II

E. ELISA C. Phase III

228. This cultured cell model is valuable in D. Phase IV

predicting the role of p-glycoprotein in
transport drugs E. NOTA

A. HT-29 233.This step is analyzing population

pharmacokinetics uses graphical and
B. T84 statistical techniques to reveal patterns in the
data ,identify potential outliers,and provide a
diagnostic tool for confirming assumptions or A. Exploratory data analysis
suggesting corrective action if assumptions
are not met. B. Population pharmacokinetic model
analysis
A. Exploratory data analysis
C. Model validation
B. Population pharmacokinetic model
analysis D. Compartmental analysis

C. Model validation E. Abstract

D. Compartmental analysis 237. Other than the intended disease to be

treated ,separate studies are usualy
E. Abstract conducted for the following conditions during
Phase III clinical trial to examine the effects on
234.Subcutaneous injection of octreotide these factors on pharmacokinetics
acetate leads to symptomatic control in
patients with acromegaly and some gastro- A. Renal disease
entero-pancreatic tumors .However to be fully
effective ,a regimen of three times daily B. Hepatic disease
dosing is warranted.To improve patient
convenience and compliance ,octreotide C. Elderly populations
acetate has been reformulated into
D. Pediatric populations
microspheres of a biodegradable polumer.
This warrants E. AOTA
A. Slow drug release of octreotide 238. This is the document through which the
active ingredient or active moiety is absorbed
B. Sustained release of octreotide
from the drug product and becomes available
C. Single monthly intragluteal injection at the site of action

D. AOTA A. IND

E. NOTA B. ANDA

235. Intragluteal injection is a form of C. NDA

A. Intravenous injection D. Choices B and C

B. Subcutaneous injection E. NOTA

C. Intramuscular injection 239. This refers to the rate and extent to

which the active ingredient or active moiety is
D. Intrathecal injection absorbed from the drug product and becomes
available at the site of action
E. NOTA
A. Bioequivalence
236.This is the step in population
pharmacokinetics evaluates the predictive B. Bioavailability
ability of the model by testing it agaisnt a
different data set ,either data from another C. Biotransformation
study or data from the study in question which
D. Biotechnology
a portion of (e.g.20%)of the total data set has
been set aside for just such purposes E. Biosimilar
240. Drug products that contain identical similar conditions in an appropriately designed
amounts of active ingredient ,i.e.,the same study
salt or ester of the same therapeutic moiety ,in
identical dosage forms ,but not necessarily A. Therapeutic equivalence
containing the same inactive ingredients
B. Pharmaceutical alternatives
A. Therapeutic alternatives
C. Bioequivalence
B. Pharmaceutical alternatives
D. Pharmaceutical equivalents
C. Bioequivalent
E. Pharmacotherapeutic alternative
D. Pharmaceutical equivalent
244. Bioavailability and /or bioequivalence are
E. Pharmacotherapeutic alternative essential for the following situations ,EXCEPT

241. Drug products that contain identical A. For all new molecular entities
therapeutic moiety or its precursor, but not
necessarily in the same amount or dosage B. For a new dosage form of a drug
form or as the same salt or ester
C. For a new salt or ester of a drug
A. Therapeutic alternatives
D. For a new indication
B. Pharmaceutical alternatives
E. AOTA
C. Bioequivalent
245.It is a measure of the extent of drug
D. Pharmaceutical equivalents absorption

E. Pharmacotherapeutic alternative A. Half-life

242. This drug product category can only be B. Volume of Distribution

met if the drug products are pharmaceutical
C. AUC
equivalents and if they can be expected to
have the same clinical effect and safety profile D. Cmax
when administered to patients under the
conditions specified in the labeling E. tmax
A. Therapeutic equivalents 246. This method of assessing the
bioavailabilty of a drug can only be used if
B. Pharmaceutical alternatives urinary excretion is the main pathway of
elimination
C. Bioequivalence
A. Urinary excretion data
D. Pharmaceutical equivalence
B. Plasma data
E. Pharmacotherapeutic alternative
C. Serum data
243. This refers to the absence of a significant
difference in the rate and extent to which the D. Half-life
active ingredient or active moiety in
pharmaceutical equivalents for E. Volume of distribution
pharmaceutical alternatives becomes
available at the site of action when 247. Gastric emptying depends on the
administered at the same molar dose under following factors,EXCEPT
 A. Viscosity of the stomach E. Complexation

B. pH of the stomach 251. The main protein fraction blood plasma is

C. Volume of liquid intake A. Histidine

D. Disease state B. Arginine

E. pKa of the drug C. Proline

248. This occurs when absorbed drug passes D. Lysine

directly through the liver before reaching the
systemic circulation after oral administration. E. Albumin

A. First-pass metabolism 252. The extent of protein binding is

determined in vitro by the following methods,
B. Intestinal metabolism EXCEPT

C. Hydrolysis of the drug in the stomach A. Dialysis

D. Transported by p-glycoprotein B. Ultracentrifugation

E. Complexation C. Agar plate test

249. This is the usual research design for D. AOTA

conducting bioavailabilty and bioequivalence
studies E. NOTA

A. two-formulation , two-period ,two- 253. Drug binding to protein can be

sequence non-replicate crossover considered as a
design
A. Reversible process
B. two-formulation, three-period ,three-
sequence non-replicate crossover B. Irreversible process
design
C. Linear
C. two- formulation, two-period ,three-
D. Nonlinear
sequence non-replicate crossover
design E. Saturated
D. two-formulation ,two-period ,two- 254. These are the known importance of drug-
sequence non-replicate cohort design protein binding
E. AOTA A. Buffer
250. This occurs when the drug is B. Transport
metabolized in the intestine itself or during the
passage through the intestinal wall C. Protection
A. First-pass metabolism D. Choices A and B
B. Intestinal metabolism E. Choices B and C
C. Hydrolysis of the drug in the stomach 255. This physiological importance of drug-
protein binding is reflected by its capacity to
D. Transported by p-glycoprotein
maintain a relatively constant concentration of A. Hyperalbubinemia
free drug over a long period of time
B. Hypoalbuminemia
A. Buffer function
C. Hypochondria
B. Transport function
D. Hyperchondria
C. Protection function
E. NOTA
D. Choices A and B
260. Bound drugs cannot be metabolized and
E. Choices B and C are not excreted, therefore

256. This physiological importance drug- A. Increases urinary excretion of drugs

protein binding is reflected with drugs of low
solubility in water B. Increases elimination half-life of drugs

A. Buffer function C. Decreases binding of hydrophilic

drugs
B. Transport function
D. Increases glomerular filtration
C. Protection function
E. AOTA
D. Choices A and B
261. Biotransformation converts drug into
E. Choices B and C
A. Polar
257. Free drug concentration ____ of plasma
binding, but is ______ on tissue binding B. Water soluble

A. Independent , dependent C. Ionized structures

B. Dependent , independent D. AOTA

C. Dependent , dissociative E. NOTA

D. Dissociative , Independent 262. The biotransformation of Protonsil results

to____ which is a more pharmacologically
E. AOTA active compound.
258.This condition is found in patients with A. Imipramine
burns , cancer, cardiac failure , cystic fibrosis,
liver impairment, and enteropathy. B. Methyldopa

A. Hyperalbubinemia C. Sulphanilamide

B. Hypoalbuminemia D. Pyridine

C. Hypochondria E. Phenacetin

D. Hyperchondria 263. The oxidation of chloral hydrate produces

E. NOTA A. Pentobarbital

259. This condition is found in patients with B. Phenobarbital

benign tumour, myalgia, neuroses, psychoses,
schizophrenia, and paranoia C. Acetic acid
 D. Dichloroacetic acid A. Phase 1

E. Trichloroacetic acid B. Phase 2

264. The principal site of drug metabolism is C. Phase 3

the
D. Phase 4
A. Kidney
E. Phase 5
B. Liver
269. Kernicterus is a condition which results
C. Lungs from

D. Heart A. Inability to conjugate albumin

E. Intestine B. Inability to conjugate bilirubin

265. The cytochrome enzymes originate from C. Inability to conjugate acetic acid

A. Cytoplasm D. Inability to conjugate glucose

B. Cell membrane E. Inability to conjugate lipids

C. Golgi apparatus 270. A one month old infant already develops

the following metabolic processes, EXCEPT
D. Microsomes
A. Sulfation
E. Ribosome
B. Conjugation
266.The following are phase 1
biotransformation reactions,EXCEPT C. Oxidation

A. Oxidation D. Acetylation

B. Reduction E. Glucoronidation

C. Hydrolysis 271. Phenobarbital and hexobarbital are

stimulated in their metabolism by auto and
D. Deamination foreign induction .This phenomenon is termed
E. methylation A. Link-induction
267. The following are phase 2 B. Time series induction
biotransformation reactions, EXCEPT
C. Scratchard induction
A. Dealkylation
D. Cross induction
B. Glycine conjugation
E. Repulsive induction
C. Acetylation
272. If a drug stimulates the rate of
D. Ethereal sulphate conjugation metabolism of another drug ,this phenomenon
is called
E. Choices B and C
A. Auto-induction
268. This metabolism phase reaction is
responsible for the formation of the final B. Foreign-induction
metabolic product of the drug to be excreted
 C. Cross-induction D. Multi compartment model

D. Anti-induction E. NOTA

E. Focus-induction 277. A blood level versus time curve for an

intravascular administration can be fitted to a
273. First pass effect cannot be observed in
the following routes of administration,EXCEPT A. One compartment model

A. Oral B. Two compartment model

B. Buccal C. Three compartment model

C. Intravenous D. Multi compartment model

D. Sublingual E. NOTA

E. Choices A and B 278. This compartment model describes a

situation in which a drug entering the body
274. It is a hypothetical structure which can be distributes instantly between the blood and
used to characterize wih reproducibility the other body fluids or tissues
behaviour and the fate of drug in biological
systems A. One compartment model

A. Concepts B. Two compartment model

B. Constructs C. Three compartment model

C. Compartments D. Multi compartment model

D. Locations E. NOTA

E. Models 279. If a drug entering the body does not

instantly distributes instantly between the
275. It is an entity which can be described by blood and other body fluids or tissues it
a definite volume and a concentration of drug eventually reaches, this can be described by
contained in the volume
A. One compartment model
A. Concepts
B. Two compartment model
B. Constructs
C. Three compartment model
C. Compartments
D. Multi compartment model
D. Locations
E. NOTA
E. Models
280. This body fluids or tissues which are in
276. A blood level versus time curve for an equilibrium with the circulatory system
extravascular administration can be fitted to a comprise the
A. One compartment model A. Central compartment
B. Two compartment model B. Peripheral compartment
C. Three compartment model C. Tissue compartment
 D. Enteral compartment D. Fourth-order reaction

E. Deep compartment E. NOTA

281. Those body fluids or tissues into which 285. Dose dependent kinetics can occur due
the drug distributes slowly comprise the to the following situations, EXCEPT

A. Central compartment A. Over loading of metabolic processes

when large doses are given
B. Peripheral compartment
B. Competition for one type of metabolic
C. Tissue compartment process by two drugs
D. Enteral compartment C. When active transport mechanisms
are overloaded
E. Deep compartment
D. AOTA
282. To know whether a one or two
compartment models applies, the terminal E. NOTA
slope of the line is back-extrapolated to the
ordinate. If no concentration-time data points 286. This is the rate constant describing the
lie above the line, this model is applicable loss of unchanged drug from the systemic
circulation by either excretion or metabolism
A. One compartment model
A. Absorption rate constant
B. Two compartment model
B. Distribution rate constant
C. Three compartment model
C. Elimination rate constant
D. Open Multi compartment model
D. Excretion rate constant
E. NOTA
E. Metabolism rate constant
283. This pharmacokinetic parameter gives
the speed at which a drug enters a 287. If a drug is given extravascularly ,this
compartment, distributes between a central rate constant describes the rate of input of
and peripheral compartments and is drug into systemic circulation.
eliminated from the systemic circulation.
A. Absorption rate constant
A. Half-life
B. Distribution rate constant
B. Volume of distribution
C. Elimination rate constant
C. Rate constant
D. Excretion rate constant
D. AUC
E. Metabolism rate constant
E. Cmax
288. With this drug product ,a solution results
284. Alcohol in the body is eliminated by in a smaller total amount of drug absorbed
than when it is given in the form of capsules
A. Zero-order reaction and tablets.

B. First-order reaction A. Aspirin

C. Third-order reaction B. Paracetamol

 C. Nifedipine D. Insufficient data

D. Griseofulvin E. NOTA

E. Metoprolol 294.If the volume of distribution in an adult is

approximately 5 liters,it means that the drug is
in
289. The following are methods to estimate A. Circulatory system
the absorption rate constant , EXCEPT
B. Extracellular fluid
A. Cmax- Truncated AUC method
C. Intracellular fluid
B. Nomogram method
D. Whole body fluid
C. Absorption time method
E. Fats
D. Ritschel method
295. If the volume of distribution in an adult is
E. NOTA approximately between 25-30 liters, the drug
is distributed in the
290. Absorption rate constant may be different
due to A. Circulatory system
A. Different drug release rate from B. Extracellular fluid
dosage form
C. Intracellular fluid
B. Disease
D. Whole body fluid
C. Viscosity of gastric content
E. Fats
D. Fasting or fed conditions
296. If the volume of distribution in an adult is
E. AOTA approximately 40 liters, the drug is distributed
in the
291. In obesity, the volume of hydrophilic
drugs is _____ expected from the body weight A. Circulatory system
A. Higher than B. Extracellular fluid
B. Lower than C. Intracellular fluid
C. Deeper than D. Whole body fluid
D. Insufficient data E. Fats
E. NOTA 297. Volumes of distribution can be estimated
in vitro by
292. In the edematic patients, the volume of
distribution of hydrophilic drug is ___expected A. Apparent partition coefficients
from the body weight
B. Extent of protein binding
A. Higher than
C. pKa and pH ratio
B. Lower than
D. Choices A and B
C. Deeper than
 E. Choices B and C

298. The most important organ for excretion

is

A. Heart

B. Lungs

C. Kidney

D. Liver

E. Intestine

299. These are the compounds which are

filtered through the glomeruli only and are
used as test substances for kidney function
test to determine the glomerular filtration rate

A. Inulin

B. Creatinine

C. Reserpine

D. Choices A and B

E. Choices B and C

300. This test is used for determination of

liver’s capacity for active transport and biliary
excretion

A. Phenolphthalein Test

B. Iodosulpthalein Test

C. Bromosulhthalein Test

D. Arabinogalactose Test

E. Methylated Resin Test