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BIOPHARMACEUTICS RED 5.

For most drugs, which part of the


gastrointestinal tract is the optimum site for
1. This corresponds to the time required for drug absorption after the oral administration?
a drug to reach the a minimum effective
concentration (MEC) A. Buccal cavity

A. onset of action B. stomach

B. intensity C. duodenum

C. duration od action D. jejunum

D. Cmax E. colon

E. AUC 6. Which of the following can increase gastric


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

A. 375 mg B. intracutaneous
B. 500 mg
C. 125 mg C. Transdermal
D. d.50 mg
E. 5 mg D. Buccal
4. Which of the following is the major process
of absorption for most drugs? E. epidermal

A. Passive Diffusion 8. Metered dose aerosols are examples of


which route of administration?
B. Active transport
A. intranasal
C. Facilitated Diffusion
B. inhalational
D. Vesicular transport
C. alveolar
E. Convective transport
D. peroral

E. respiratory
CORRECT ANSWER: B. Disintegration

D. inhalational C. Gastric Emptying

9. Which of the following routes of D. Dissolution


administration has/have no first-pass effect
E. Dispersion
I. buccal
13.For most conventional solid drug products,
II. sublingual which of the following is the rate limiting step
for bioavailability?
III. oral
A. Liberation
IV. rectal
B. Disintegration
A. I only
B. II only C. Solubility
C. I & II
D. d.III only D. Dissolution
E. I, II and IV
10. Which of the following is the plasma level E. Attrition
time curve of an open intravascular two-
compartment model 14. These products are the first ones to be
patented or granted certain exclusivities

A. generic medicines

B. innovator products

C. multi source drug products

D. market leader

E. reference
11. If the AUC for the Phenobarbital 15. Which of the following products are
administered orally by tablet is 6.5 mcg/mL x considered to be pharmaceutical equivalents?
hr and the AUC for the Phenobarbital solution
can give the same dose and route is 8.4 A. Mefenamic acid 250 mg cap &
mcg/mL calculate the relative bioavailability of mefenamic acid 500 mg cap
the drug.
B. amlodipine besylate (innovator) 10
a. 129.23% d. 56. 38% mg tab & amlodipine besylate
(generic) 10 mg tab
b. 100% e. 43.62%
C. amoxicillin 500 mg cap & amoxicillin
c. 77.38% 250 mg/mL susp.
12. This is the process by which a solid drug D. Clindamycin HCl 300 mg cap &
substance becomes dissolved in a solvent clindamycin phosphate 150 mg/mL
amp x 4 mL
A. Liberation
E. Paracetamol (Brand A) 500 mg tab & E. e. I to IV
paracetamol (Brand B) 500 mg cap
19. Among the following oral drug formulation,
16. Which of the following drug products are which is considered to be the most
considered to be pharmaceutical alternatives? bioavailable?

A. cephalexin 500 mg cap & cefalexin A. Solution


500 mg cap
B. Suspension
B. propranolol 10 mg tab (branded) &
propranolol 10 mg tab (unbranded) C. Emulsion

C. nifedipine 5 mg cap & nifedipine 20 D. Powder


mg mg GITS tab
E. Granule
D. ranitidine HCl (local) 150 mg tab &
20. Dispensing ibuprofen instead of naproxen
ranitidine HCl (imported) 150 mg tab
is an example of:
17. This describes the passive diffusion of the
A. generic dispensing
drugs across the gastrointestinal blood barrier
B. pharmaceutical substitution
A. Fick’s First law
C. pharmaceutical equivalence
B. Noye’s-Whitney equation
D. therapeutic equivalence
C. Henderson-Hasselbach Equation E. therapeutic substitution
21. A drug has high solubility but low
D. Clausius-Clapeyron Equation
permeability may be classified based on the
E. Raoult’s law Biopharmaceutics classification system as:

18. Bioequivalence can be assessed using A. Class 1


which of the following methods?
B. Class 2
I. in vivo pharmacokinetics studies involving
C. Class 3
plasma or urine drug concentrations as a
function of time D. Class 4

II. In vivo pharmacodynamic studies E. Class 5

III. Comparative clinical trials 22. Which of the following physicochemical


properties of a drug will result to a faster
IV. Comparative in vitro studies
dissolution rate?
A. a.I only
A. small surface area
B. unionized form
B. b. I,II
C. high partition coefficient
C. c. III only D. amorphous form
E. large particle size
D. d. I to II 23. in the BCS class the drug dissolves rapidly
and is well absorbed and bioavailability
problem is not expected for immediate-release E. partition coefficient
drug products
26. This refers to the systemic availability of a
A. Class 1 drug after extravascular administration
compared to IV dosing.
B. Class 2
A. bioavailability
C. Class 3
B. bioequivalence
D. Class 4
C. relative bioavailability
E. Class 5
D. absolute bioavailability
24. Enteric coating used to:
E. therapeutic equivalence
I. mask the taste or odor of a drug
27. Parameters used to assess bioavailability/
II. Minimize irritation of gastric mucosa by the biotaquivalence using plasma drug
drug concentration
III. Protect the drug from moisture, light, air A. tmax, Cmax
IV. Prevent inactivation or degradation of the B. tmax, Cmax, AUC
drug in the stomach
C. tmax, Emax
V. delay the release of the drug until the
dosage from the reaches the small intestine, D. t, Du
where the condition for absorption may be
optimal E. t,Du dDu /dt

A. I & II 28.Drugs given by this route of administration


are considered to be 100% bioavailable
B. II & IV
A. Oral
C. V only
B. Sublingual
D. II, IV & V
C. Intravenous
E. I to V
D. Subcutaneous
25. This is an indication of the lipid solubility of
a drug and its likelihood of being transported E. intramuscular
across membrane.
29. Which of the following is NOT an
A. polymorphism extended-release drug product?

B. permeability A. sustained release capsule

C. pH B. enteric-coated tablet

D. pKa C. slow-release tablet

D. prolonged-action drug product


E. repeat-action tablet 33. Pharmaceutical Equivalents are drug
products that have the same
30. This term is applied to a regulatory
approval process in which an application is I. active pharmaceutical ingredients (API)
approved based on experience of equivalence
of a generic drug bioequivalence/in vivo II. Chemical form of the API
equivalence testing.
III. Dosage form
A. dossier
IV. Dosage strength
B. abbreviated new drug application
(ANDA)
V. route of administration
C. in vivo-in vitro correlation (IVIVC)
D. biowaiver
VI. Standards of identity, strength, quality and
E. e. clinical trials
31. This refers to the trade name of the drug purity
product which is privately qwned by the A.I, II
manufacturer or distributor and is used to
distinguish is the specific drug product from B.II, III, IV
those of competitors.
C.I, II, III
A. generic name
D.I to V
B. chemical name
E. I to VI
C. brand name
34. This reference identifies drug products
D. market name approved on the basis of safety and
effectiveness by the US FDA and contains
E. INN therapeutic equivalence evaluation for
32. In the generalized plasma level time curve approved multisource prescription drug
shown below, which letter corresponds to the products
intensity of action? A. USP/NF

B. Orange book

C. PNDF

D. Essential Drug list


In C
E. International pharmacopeia

CORRECT ANSWER:

B. Orange Book

35. Which of the following methods is


used to determine AUC?
CORRECT ANSWER:
a. feathering d. analysis of variance
C.
(ANOVA)
b. back-extrapolation e. two one sided B. B
test
C. C I
c. trapezoidal rule
D.D
36. Pharmaceutical alternatives are products
that have the same E.E

I. active pharmaceutical ingredients (API) 37. It refers to the finished dosage form that
contains the active drug ingredient generally,
II. chemical form of the API but not necessarily in association with inactive
ingredients
III. dosage form
A. formulation
IV. dosage strength
B. therapeutic moiety
V. route of administration
C. drug product
VI. standards of identity, strength, quality and
purity D. Drug delivery system

A.I only E. reference listed drug

B.III, IV, V 39. This must be filed by generic drug


manufacture for approval to market a generic
C.I, III, IV drug product
D. I, V A. abbreviated new drug application
(ANDA)
E. I to IV
B. new drug application (NDA)
37.It refers to the unfinished dosage form that
contains the active drug ingrdient ,generally C. investigational new drug application
,but not necessarily ,in association with active (INDA)
ingredients.
D. biowaiver
A. formulation
E. BA/BE study
B. therapeutic moiety
40. The processes of drug metabolism and
C. drug product excretion constitute
D. drug delivery system A. deposition
E. reference drug list B. elimination
38.In the given plasma-level time curve C. accumulation
below ,identify the letter that corresponds to
the onset of action. D. biotransformation

A. A E. clearance
41. It is the term used to describe the B. maximum plasma drug concentration
accidental fast release of drug from a (Cmax)
sustained release dosage form
C. bioavailability
A. liberation
D. bioequivalence
B. steady state
E. therapeutic equivalence
C. dose dumping

D. flip flop model


45. Therapeutic equivalence is established
E. first pass effect when the drug prosuct being compared are:

42. This is the rate and extent to which the I. approved as safe and effective
active pharmaceutical ingredient or active
moiety is absorbed from a drug product and II. pharmaceutical equivalents or alternatives
becomes available at the site of action
III. bioequivalent
A. area under the curve (AUC)
IV. manufactured in compliance to cGMP
B. maximum plasma drug concentration
IV. adequately labeled
(Cmax)
A.I only
C. bioavailability
B.III only
D. bioequivalence
C.I, II, III
E. therapeutic equivalence
D. I to IV
43. This is a measure of the quantity of the
drug in the body and ref;ects the total amount E.I to V
of active drug that reaches the systemic
circulation. 46 .To establish bioequivalence the calculated
confidence interval should fail within the
A. area under the curve (AUC) usually prescribed limit of ___ for the ratio of
the product averages
B. maximum plasma drug concentration
(Cmax) A.50-100%

C. bioavailability B.90-110%

D. bioequivalence C.80-120%

E. therapeutic equivalence D. 95-100%

44. This established when pharmaceutical E. 80-125%


equivalents or alternatives display comparable
bioavailabilities when studied under similar 47. Generally, two drug product formulations
experimental conditions whose rate and extent of absorption differ by
__% or less are considered bioequivalent.
A. area under the curve (AUC)
A. 50 D. 20 B. Recirculation E. Residence

B.40 E. 10 C. Reactivation

C. 30 52. It is the study of how the physicochemical


properties of a drug, dosage forms and route
48. For drugs that have very poor aqueous s of administration affect the rate and extent of
solubility the rate limiting step on drug drug absorption.
bioavailability is:
A. LADMER system D. Biopharmaceutics
A. disintegration
B. Pharmaceutics E. Pharmacokinetics
B. dissolution
C. Physical Pharmacy
C. permeation
53. This is actual site of pharmacologic action
D. gastric emptying of drugs in the body
E. disaggregation A. compartment D. cytosol
49. Which of the following is NOT true? B. biophase E. plasma
A. The amorphous form of the drug C. cell membrane
generally dissolves faster
54. Which of the following absorption
B. Polymorphs have the same chemical mechanism operate along concentration
structures and physical properties gradient?
C. Some excipients are intentionally I. passive diffusion II. Active transport
added to delay drug absorption
III. facilitiated diffusion IV, vesicular transport
D. smaller particles size increases
dissolution rate A.I only

E. a basic drug is more soluble in an B.III only


acidic medium
C.I and III
50. The tmax of a drug refers to its time:
D. II and IV
A. of the fastest dissolution
E.I to IV
B. to reach maximum drug concentration
55. This is the fraction of an administered
C. of highest solubility dose of a drug that reaches the systemic
circulation in the unchanged form.
D. to reach maximum toxic concentration
A. bioavailable dose D. dumped dose
E. of maximum effectiveness
B. loading dose E. oral dose
51. In the LADMER system, R stands for?
C. maintenance dose
A. Reabsorption D. Response
56. a 125 mg/mL drug suspension D. fluid mosaic
decompose with a zero order rate constant of
0.5 mg/mL/hr. What is the concentration of the E. unit membrane
active drug remaining after 3 days
60. This refers to the ability of a drug to exixt
A. 125 D. 89 in more than one crystalline form.

B. 123.5 E. 62 A. amphoterism

C. 100 B. crystallization

57.In the generalized plasma level –time C. polymorphism


curve given below ,what corresponds to the
D. ionization
broken line E.
E. complexation
A. Maximum drug concentration
61. Dissolution rate differ for hydrated and
(Cmax)
anhydrous forms of a drug however, the most
B. Onset of action usual situation is:

C. Minimum effective A. the anhydrous form dissolves faster


concentration(MEC)
B. the hydrated form dissolves faster
D. Duration of action
C. the anhydrous and hydrated forms
E. Intensity have equal dissolution rates

58. Example of a targeted drug delivery D. the hydrated form has no effect on
system dissolution

A. osmotic pumps E. the anhydrous form has no effect on


dissolution
B. enteric-coated tablets
62. Equivalence are not necessary for which
C. liposomes of the following products

D. cyclodextrins I. Parenteral aqueous solution

E. implants II. Pharmaceutically equivalent oral solutions

59. This concept views the cell membrane as III. pharmaceutically equivalents topical
being composed of a non-rigid lipid matrix with solutions
which are associated relatively mobile protein
masses that penetrate wholly or partially IV. products containing drugs with narrow
through the lipid layer therapeutic indices

A. lipid bilayer model A. I only

B. phospolipid matrix theory B. IV only

C. lipoprotein compartment C. II and III


D. I to III D. buccal

E. I to IV E. topical

63. Which of the following transport 67. Which of the following is NOT an enteral
mechanism does not require a drug to be in route of drug administration
aqueous solution in order to be absorbed?
A. sublingual
A. passive diffusion
B. buccal
B. convective transport
C. rectal
C. carrier mediated transport
D. Peroral
D. ion transport
E. None of the previous choices
E. vesicular transport
68. Which of the following compounds may be
64. These are added to a formulation to absorbed via convective transport?
provide certain functional properties to the
drug and dosage form A. Vitamin B12

A. prodrugs B. inorganic and organic electrolytes with


molecular weights up to 400
B. xenobiotics
C. most weal organic acids and bases
C. probiotics
D. fats
D. excipients
E. quaternary ammonium compounds
E. active ingredients
69. Determine the half-life of an
65. The LADMER system is essential in the : antihypertensive drug if it appears to be
eliminated from the body at a rate constant of
A. development of dosage forms 0.07 hour. Assume first order kinetics occurs.
B. determinations of pharmacokinetic A. 12
parameters
B. 9.9
C. evaluation of bioavailability
C. 7
D. adjustment of dosage regimen
D. 4
E. all of the given choices
E. 1.5
66. This is the most common and popular
route of the drug administration 70. Which of the following statements is NOT
true?
A. oral
A. a cell membrane is a semi permeable
B. parenteral structure composed of lipids and
proteins
C. rectal
B. Drugs bound to protein do not easily 74. Which of the following is NOT a
cross cell membranes characteristic of active transport?

C. Ionic or polar, water- soluble drugs A. drug moves along concentration


cross cell membrane more easily than
do nonpolar, lipid soluble drugs. B. process requires expenditure of
energy
D. low molecular weights drugs diffuse
across cell membrane more easily C. requires a carrier
than do high molecular weight drugs
D. saturable at high drug concentration
E. drugs may transported by passive
E. process is subject to competition
diffusion, carrier-mediated,
paracellular or vesicular transports 75. These are addition compounds of drugs
and organic solvents
71. Most drugs are:
A. hydrates
A. strong electrolytes
B. solvates
B. non electrolytes
C. polymorphs
C. weak acids
D. clathrates
D. weak bases
E. chelates
E. C and D
76. Which of the following statements is false?
72. Which of the following is/are forms of
vesicular transport that differ by the type of A. In general, salts of electrolytes
material ingested? dissolve faster than the free acids or
bases
A. I only
B. the most stable polymorphs has the
B. III only
lowest dissolution rate
C. I and II
C. Increasing amounts of binders in
D. III and IV grabukes and tablets prolong
dissolution time.
E. I to IV
D. Increasing amounts of lubricants
73. The drug is injected into the spinal fluid shortens dissolution time

A. intraarticular E. particle size reduction is not a


universal answer to all drugs of low
B. epidural solubility
C. Intracranial 77. The enormous surface are of the
gastrointestinal tract is due to presence of:
D. Intrathecal
A. enzymes
E. intrasynovial
B. microvilli E. transdermal

C. parietal cells 81. Type of parenteral administration in which


the drug is injected slowly into the plasma at a
D. tight junctions constant or zero-order rate
E. gastric pits A. IV push
78. In oral drug administration, the drug is B. IV bolus
swallowed undergoes absorption from the
gastrointestinal tract through the mesenteric C. IV infusion
circulation to the ___ into the liver and then to
the systemic circulation D. IM

A. hepatic portal vein E. SQ

B. biliary duct 82. The pharmacological effect of a drug


depends on the percentage of receptors
C. aorta occupied

D. jugular vein A. Lock and key hypothesis

E. superior vena cava B. Hypothesis of paton

79. A condition in which the rate of drug C. Hypotheses of Ariens and Stephenson
leaving the body is equal to the rate of drug
entering the body. D. Hypothesis of clark

A. double-peak phenomenon E. Occupation theory

B. flip-flop model 83. the drug molecules is bound to the surface


of the skin or mucosa by ion-binding,
C. first-pass effect hydrogen-binding or van der waals forces:

D. steady state a. absorption

E. therapeutic window b. penetration

80. The route of drug administration that is c. Adsorption


preffered when rapid absorption is essential,
when patients are inconscious or unable to d.Permeation
accept medications by mouth or when drugs
e. leaching
are destroted, inactivated or poorly absorbed
in the GIT. 84. It describes the diffusion-controlled rate of
drug dissolution
A. peroral
A. Henderson-hasselbach equation
B. sublingual
B. fick’s law of diffusion
C. parenteral
C. Michaelis-menten equation
D. Rectal
D. Noyes-whitney equation 88. This is the time from drug administration to
reach the minimum effective concentration
E. Van slyke’s equation (MEC)
85. which of the following parameters will a. onset d. therapeutic window
determine the degree of drug ionizations?
b. intensity e.area under the curve(AUC)
I. lipid/ water coefficient of the drug
c. duration of action
II. pH at the absorption rate
90. This refers to the drug concentration
III. pKa of the drug range between the minimum effective
concentration (MEC) and the minimum toxic
A. I only
concentration (MTC)
B. I and II
a. onset
C. I and III
b. intensity
D. II and III
c. duration of action
E. I,II and III
d. therapeutic window
86. What is the minimum percent of drug that
e. area under curve
must be in the nonionized form at the small
intestine in order to be absorbed via passive 91. This describes the relationship between
diffusion the ionized and the nonionized forms of a
drug as a function of pH and pKa.
a. 0.1% to 1% d. 50% to 60%
a. Law of Multiple proportions
b. 1 to 5% e. 80% to 90%
b. Nernst Distribution Law
c. 10 to 20%
c. Henderson-Hasselbach equation
87. The partition coefficient is a/an:
d. common-ion effect
A. in vitro guide to the absorption
potential of a drug e. partition coefficient
B. measure of the relative affinity of a 92. Which of the following is a common site
drug for two immiscible phases for IM injection?
C. indicator for storage of drugs in fat a. gluteus medius
D. parameter of the relative rate of b. thigh e. ebdomen
partitioning from one phase into
another c. Gastrocnemius

E. all of the given choices d. gluteus maximus

e. abdomen
93. It refers to the time for which the drug 98. Cmax represents the maximum drug
concentration remains above the minimum concentration obtained after oral
effective concentration (MEC) administration of a drug in the:

a. duration of action d. Cmax A. plasma D.feces

b. intensity e. onset B. urine E. sweat

c. tmax C. saliva

94. Which of the following oil phases is most 99. This is an entity which can be described
commonly used in partition coefficient by a definite volume and a concentration of
determination? drug contained in that volume

a. chloroform d. mineral oil A. biophase D. compartment

b. cyclohexane e. octanol B. bulk phase E. depot phase

c. isopropyl myristate C. diffusion layer

95. Maximum volume to be injected via the 100. Order reaction in which the concentration
intramuscular route: of a drug is decreasing at a rate that is
proportional to the concentration of the drug
a. 0.5 mL d. 5 mL remaining:
b. 1 mL e. 10 mL A. zero D. third
c. 2 mL B. first E. fourth
96. This is the dose used in initiating therapy C. second
so as to yield therapeutic concentration which
will result in clinical effectiveness 101. Facilitated diffusion is similar to active
transport since it:
A. daily dose D. loading dose
A. operates against concentration
B. First dose E. effective dose gradient
C. prophylactic dose B. utilizes energy in the form of ATP
97. This is the dose required to maintain the C. is carrier mediated
clinical effectiveness or therapeutic
concentration according to the dosage D. None of the choices
regimen.
E. all of the given choices
A. therapeutic dose D. priming dose
102. Decreased particle size results to:
B. maintenance dose E. effective dose
A. increased particle surface area
C. steady-state dose
B. enhanced water penetration into particles

C. increased dissolution rate


D. none of the choices A. zero-order kinetics

E. all of the above B. first-order kinetics

103. When drug is half ionized and half C. half-life


nonionized at a certain pH, its pKa is:
D. rate-limiting step
A. greater than pH
E. clearance
B. less than pH
107. These are inactive substances that must
C. equal to pH be biotransformed in the body to metabolites
that have pharmacologic activity
D. of no value
A. xenobiotics
E. constant
B. lead compounds
104. This is obtained when the drug product is
administered at the site where the C. prodrugs
pharmacological response is desired and
when the drug released from the products D. therapeutic moieties
acts by adsorption to the skin or mucosa, but
E. orphan drugs
does not enter the systemic blood circulations
108. Reabsorption of drugs can occur in the
A. systemic effect
I. kidneys
B. local effect
II. Liver
C. therapeutic response
III. Small intestines
D. Biological response
A. I only
E. dermal effect
B. II only
105. This is obtained when the drug released
the drug product enters the bloodstream and C. III only
is distributed within the body regardless of the
site and route of administration D. I and II

A. systemic effect E. I and III 

B. local effect 109. The form of the drug that is absorbed:

C. therapeutic effect I. nonionized

D. biological response II. Ionized

E. dermal effect III. lipid-soluble

106. This is the process with the slowest rate IV. Water-soluble
constant in a system of simultaneous kinetic
a. I only
processes.
b. II only A. independent of the concentration
gradient
c. I and III
B. inversely proportional to the surface
d. II and IV area of the membrane
e. I to IV C. inversely proportional to the
membrane thickness
110. What is the % of ionized species of a
weak acid with a pKa of 4.2 in a urine pH of D. inversely proportional to the partition
6.2? coefficient of the drug
a. 0.1 E. independent of the diffusion coefficient
of the drug
b. 1
115. Highly lipid soluble drugs are
c. 10
predominantly distributed in which of the
d. 90 following tissues?

e. 99 A. bone

111. Which of the following is devoid of B. adipose


clotting proteins?
C. muscle
A. blood
B. plasma D. hepatic

C. serum E. renal

D. both B and C 116. These are substances that have no


pharmacological properties of their own in the
E. all of the given choices concentration used, but which can improve
the penetration of drugs into the skin or
112. Drug entering the body does not instantly mucosa.
distribute between the blood and those other
body fluids or tissues which it eventually A. humectants
reaches
B. emollients
A. open one-compartment model
C. sorption promoters
B. open two-compartment model
D. wetting agents
C. multi-million compartment model
E. solubilizers
D. central compartment
117. Absorption mechanism in which drug
E. peripheral compartment molecules dissolved in aqueous medium at
the absorption site move along with the
113. According to the Fick’s Law, the rate of solvent through membrane pores:
diffusion of a drug is:
A. passive diffusion
B. active transport 121. Which of the following is the correct rank
order (from the most bioavailable to the least)
C. facilitated diffusion for the given conventional oral formulations?
D. convective transport A. coated tablet> uncoated tablet>
capsule> suspension> solution
E. ion-pair transport
B. solution> suspension> capsule>
118. Which of the following absorption
coated tablet> uncoated tablet
mechanisms operate(s) against concentration
gradient? C. suspension> solution> uncoated
tablet> coated tablet> capsule
I. passive diffusion
D. solution> suspension> capsule>
II. Facilitated diffusion
uncoated tablet> coated tablet
III. Active transport
E. capsule> uncoated tablet> coated
A. I only tablet> solution> suspension

B. II only 122. Excipients are added to product


formulations to:
C. III only
A. facilitate preparation
D. I and II
B. improve patient acceptability of the
E. II and III product

119. Rate constants in pharmacokinetics are C. improve functioning of the dosage


usually: form as a drug delivery system

A. zero-order D. all of the choices

B. first-order E. none of the choices

C. second-order 123. An aqueous phase (pH 7.4 buffer)


containing a drug, was shaken with an oil
D. third-order
phase (octanol) and the mixture was then left
E. fourth-order to reach equilibrium. The two phases were the
separated and the concentration of the drug in
120. Cyancobalamin is a classical example of each phase was measured. The resulting
a drug that is absorbed via: values were as follows: C octanol = 18; C
buffer = 2. Based from the results, calculate
A. convective transport the partition coefficient of the drug.
B. facilitated diffusion A. 36
C. vesicular transport B. 20
D. passive diffusion C. 16
E. ion-pair transport D. 9
E. 0.11 C. solubilization

124. These are drugs in which the D. all of the choices


pharmacological action is not directly
dependent on the chemical structure of the E. none of the choices
drug.
128. Which of the following is/are the effect/s
A. structural nonspecific drugs of food on the bioavailability of a drug from a
drug product?
B. structural specific drugs
A. delay in gastric emptying
C. drug-receptor complexes
B. stimulation of bile flow
D. ligands
C. physical or chemical interaction of the
E. substrates meal with the drug product or drug
substance
125. If the volume of distribution of a drug in
an adult is approximately 5L, it means that the D. a change in the pH of the GIT
drug is confines to the:
E. all of the given choices
A. circulatory system
129. In passive diffusion, the term passive
B. extracellular fluid pertains to what characteristic of this
absorption mechanism?
C. intracellular fluid
A. moves along concentration gradient
D. whole body fluid
B. a carrier mediated process
E. deep tissues
C. does not require the expenditure of
126. Surfactants are used: in dosage forms energy
as:
D. is subject to competition
A. emulsifying agents
E. has saturation point
B. solubilizing agents
130. This is the loss of drug from the central
C. suspending agnets compartment due to transfer into other
compartments and/or elimination
D. wetting agents
A. absorption
E. all of the given choices
B. distribution
127. Which of the following is/are technique/s
used to increase the aqueous solubility of C. penetration
poorly water-soluble drugs?
D. disposition
A. cosolvency
E. permeation
B. complex formation
131. Which of the following is/are the D. III to V
equation/s of a first-order reaction?
E. II to V
I. C= -k0 t + C0
134. Which of the following processes occurs
II. In C= -kt + In C0 mostly in the proximal convoluted tubule
(PCT)?
III. log C = -(k/2.3)t + log C0
A. glomerular infiltration
IV. C = C0e –kt
B. tubular secretion
A. I only
C. tubular reabsorption
B. II only
D. both B and C
C. III only
E. all of the given choices
D. II to IV
135. In order to excrete amphetamine more
E. I to IV quickly in the urine, which of the following may
be used intravenously?
132. The half-life of a given drug is 6 hours.
How many half-lives have passed 24 hours A. urinary acidifier
after administration?
B. urinary alkanizer
A. 24
C. inulin
B. 12
D. creatinine
C. 10
E. all of the choices
D. 6
136. If the AUC for an oral dose of a drug
E. 4 administered by tablet is 4.5 mcg/mL/hr, and
the intravenous dose is 11.2 mcg/mL/hr,
133. Which of the following is NOT an
calculate the absolute bioavailability (in %) of
extravascular route of drug administration?
the oral dose of the drug.
I. oral
A. 2.5
II. rectal
B. 10
III. intramuscular
C. 15
IV. subcutaneous
D. 40
V. intravenous
E. 62
A. I only
137. The normal glomerular filtration rate
B. V only (GFR) is:

C. I and II A. 125-130 mL/min


B. 90-100 mL/min B. 56.9%

C. 60-90 mL/min C. 42.2%

D. 30-59 mL/min D. 23.6%

E. ,15 mL/min 141. If the volume of distribution exceeds the


body weight, it is assumed that the drug is:

A. stored in body fat


138. A patient received a single intravenous
dose of 300mg of a drug substance that B. bound to body tissues
produced an immediate blood concentration
of 8.2 mcg/mL. Calculate the volume of C. distributed to deep tissues in
distribution in liters(L). peripheral compartments

A. 36.6 D. A and B

B. 27.3 E. all of the above

C. 20.5 142. If the half-life for decomposition of a drug


is 12 hours, compute for the first-order rate
D. 10.6 constant.

E. 8.7 A. 0.693/hr

139. The peripheral compartment is B. 0.510/hr


subdivided into:
C. 0.267/hr
A. central compartment
D. 0.058/hr
B. shallow compartment
E. 0.012/hr
C. deep compartment
143. Vegetables and fruits, and diets rich in
D. both A and B carbohydrates result to a/an:

E. both B and C A. decrease in urinary pH

140. The bioavailability of a new B. increase in urinary pH


investigational drug was studied in 24
volunteers. Each volunteer received either a C. increase GFR
single oral tablet (200mg), 5ml of a pure
D. decrease GFR
aqueous solution (200mg) or a single IV bolus
injection (50mg). The average AUC values are E. none of the choices
given below. From these data, calculate the
absolute bioavailability of the drug. 144. The central compartment refers to the:

104% A. body fluids or tissues into which the


drug distributes slowly
A. 59.2%
B. compartment that is not accessible by
blood sampling
148. This concept in pharmacokinetics is a
C. body fluids or tissues which are in hypothetical structure which can be used to
equilibrium with the circulatory system characterize with reproducibility, the behavior
and the fate of a drug in biological systems
D. both A and B when given by a certain route of
administration and in a particular dosage
E. both B and C
form.
145. The differences in bioavailabilities of
A. biophase
drug products may be due to:
B. compartment
A. physiological factors
C. model
B. drug factors
D. order
C. dosage from design
E. rate constant
D. both B and C
149. If the bioavailability of digoxin in a
E. all of the given choices
0.25-mg tablet is 0.60 compared to the
146. Which of the following is/are eliminated in bioavailability of 0.75 in a digoxin elixir
the body solely by filtration? (0.05mg/mL), calculate the dose (in mL) of the
elixir equivalent to the tablet.
A. inulin
A. 0.0375
B. creatinine
B. 0.15
C. electrolytes
C. 0.5
D. both A and B
D. 3
E. both B and C
E. 4
147. A solution of a drug was freshly prepared
at a concentration of 300mg/ml. After 30 days 150. The concentration of a drug remaining
at 25°C, the drug concentration in the solution after 180 min was 5mg/dL from an initial conc.
was 75mg/mL. Assuming first-order kinetics, of 60mg/dL. Compute for the first-order rate
when will the drug decline to one-half of the constant.
original concentration?
A. 0.001/min
A. 0.046 day
B. 0.02/min
B. 0.5 day
C. 0.0138/min
C. 7 days
D. 0.693/min
D. 10 days
E. 0.05/min 
E. 15 days
151. In IV infusion, it is essential to administer 155. It refers to the net transfer of a drug from
the dose in order to immediately reach the the circulating fluids of the body to various
steady state. tissues and organs.

A. Loading dose A. Absorption


B. Distribution
B. Maintainance dose
C. Metabolism
C. Titered dose
D. Excretion
D. Priming dose
E. NOTA
E. Choices A and D
156. This refers to the extent of fraction of
152. This is the dose used in initiating therapy drug absorbed upon extravascular
so as to yield therapeutic concentration which administration in comparison to the dose size
will result in clinical effectiveness. administered.

A. Loading dose A. Relative bioavailabilty

B. Priming dose B. Absolute Bioavailability

C. Initial dose C. Pharmacokinetics

D. Choices A,B or C D. Biopharmaceutics

E. NOTA E. NOTA

153. Passive diffusion follows 157. This method to estimate the area under
the curve is used if no curve fitting has been
A. Noyes Whitney
done for a set of blood level curve is not
B. Graham’s smooth if no pharmacokinetic data have been
determined.
C. Fick’s
A. Counting rule
D. Hess
B. Weighing rule
E. NOTA
C. Trapezoidal rule
154. Cyanocobalamine can be absorbed
through this transport mechanism. D. Jelliffe Rule

A. Passive Diffusion E. Crock’s Rule

B. Convective 158. These processes are collectively referred


to as elimination.
C. Active
A. Absorption
D. Facilitated
B. Metabolism
E. Ion pair
C. Excretion
D. Choices A and B C. Biotrans

E. Choices B and C D. Biophase

159. This is the sum of all body regions in E. Microsomes


which the drug concentration is in
instantaneous equlibrium with that in blood or 163. This refers to the hypothetical volume of
plasma. distribution in mL of the unmetabolized drug
which is cleared per unit of time by any
A. Central Compartment pathway of drug removal

B. Peripheral Compartment A. Volume of Distribution

C. Compartment B. Clearance

D. Tissues C. Concentration gradient

E. System D. Half-life

160. This type of intravenous administration E. Absorption


can be considered as multiple dosing with
infinitely small dosing intervals. 164. Albumin concentration is reduced in
newborns and infants.This may result in
A. IV bolus ______volume of distribution and______in
free drug concentration in plasma
B. IV infusion
A. Increased,decreased
C. IV Bolus(Multiple dose)
B. Decreased,increased
D. IV push
C. Increased,increased
E. NOTA
D. Decreased,decreased
161. These processes are collectively called
disposition E. NOTA

A. Distribution 165. Half-life depends on

B. Metabolism A. Volume of distribution

C. Excretion B. Clearance

D. Choices A and B C. Absorption rate

E. AOTA D. Choices A and B

162. This refers to the anatomical location of E. Choices B and C


the receptors for a drug.
166. In clinical terms ,it is defined as the
A. Enzymes millimeters of blood cleared of drug per minute

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

C. Fraction absorbed A. Pre-systemic metabolism

D. Fraction excreted B. First pass effect

E. Fraction distributed C. Enterohepatic recycling


D. Choices A and B A. Toxicity

E. Choices B and C B. Adverse effects

174. This refers to the time in hours necessary C. Side effects


to reduce the drug concentration in the blood,
plasma , or serum to one-half equilibrium is D. Therapeutic failure
reached
E. Narrow therapeutic index
A. Half-life
178. Why do pharmacokineticists measure
B. Clearance drug levels?

C. Elimination A. Design of a dosage regimen

D. Hepatic Clearance B. Maintain drug at optimum drug levels

E. Gastric Emptying C. Confirm patient compliance

175. This is used to describe the process of D. AOTA


taking drug concentrations ,basic
E. NOTA
,pharmacokinetic principles , and the person’s
clinical response and combining them to 179. Drug levels are measured at this time
optimize drug therapy for the patient period to assess the current therapy

A. Clinical Pharmacokinetics A. Minimum therapeutic concentration

B. Therapeutic Drug Monitoring B. Maxinum toxic cocentration

C. Applied Pharmacokinetics C. Steady State Level

D. AOTA D. AOTA

E. NOTA E. NOTA

176. At steady state ,the longer the 180. This is the final elimination of a drug from
elimination half-life and the shorter the dosing the body’s systemic circulation via the kidney
interval, into urine ,via bile and saliva into the
intestines,and into feces,via sweat,skin,and
A. the less will be the fluctuation
milk.
B. the higher will be the fluctuation
A. Enterohepatic recycling
C. the more will be the fluctuation
B. Metabolism
D. Choices B and C
C. Excretion
E. NOTA
D. Urination
177. Blood level determinations are done
E. Clearance
when a medication has a
181. These are usually measured if a drug is D. After the elimination phase
given by extravascular administration or
intermittent infusion and it demonstrates a E. NOTA
significant difference in concentration before
185. Drug concentrations are obtained by
end after dosing.
A. Venipuncture of the venous blood
A. Peak concentration
B. Venous of arterial blood
B. Trough concentration
C. Venipuncture of jugular blood
C. Steady State concentration
D. Choices A and B
D. Choices A and B
E. Choices B and C
E. AOTA
186. The larger amount of total body fluid and
182. This is the increase in enzyme content or
the very small amount of fat tissue in infants
rate of enzymatic processes resulting in faster
make it likely that the volume of distribution of
metabolism of a compound.
hydrophilic compounds is_____ and that of
A. Enzyme Restriction lipophilic ones is_____

B. Enzyme Inhibition A. Increased, decreased

C. Enzyme Imbibition B. Decreased, increased

D. Enzyme Induction C. Increased, increased

E. Enzyme Coagulation D. Decreased, decreased

183. The peak for an intravenous bolus dose E. NOTA


would be obtained.
187. If a drug stimulates its own metabolism.it
A. Immediately after the dose is given is called

B. Right after the infusion stops A. Oxidation

C. After the distribution B. Reduction

D. After the elimination phase C. Auto oxidation

E. NOTA D. Auto induction

184. The peak concentration following an IV E. Enzyme Inhibition


infusion of a drug usually occur
188. This refers to a graphical method for
A. Immediately after the dose is given separation of exponents such as separating
the absorption rate constant from the
B. Right after the dose stops elimination rate constant.

C. After the distribution phase A. Residual Method


B. Feathering B. Minimum inhibitory concentration

C. Interpolation C. Minimum effective concentration

D. Extrapolation D. Minimum therapeutic concentration

E. Choices A and B E. Maximum therapeutic concentration

189. This is the most frequently used assay 193. This refers to a change of one or more of
method for therapeutic drug monitoring. the pharmacokinetic parameters during
absorption,metabolism and excretion by
A. Radioimmunoassay saturation or overloading of processes due to
increase dose size.
B. Gas Chromatography
A. Saturation kinetics
C. Microbiological assay
B. Non-linear kinetics
D. Enzyme multiplied immunoassay
C. Linear kinetics
E. NOTA
D. First pass effect
190. It is the sum of all chemical reactions for
biotransformation of endogenous and E. Choices A and B
exogenous substances which take place in
the living cell 194. This is observed upon topical or rectal
route of administration where the absorption is
A. Absorption slower than the elimination.
B. Elimination A. Flip-Stock Model
C. Metabolism B. Flip-Top Model
D. Excretion C. Flip-Flop Model
E. Clearance D. Flip-Stop Model
191. It can be determined using a person’s E. Flip-Stoop Model
weight in kilograms and height in centimeterss
195. It is a measure of the rate and extent of
A. Creatinine clearance drug absorption
B. Lean Body weight A. Cmax
C. Average Body weight B. AUC
D. Body Surface Area C. BA
E. NOTA D. F
192. It is the lowest concentration of a drug E. Ka
that arrests or inhibits the growth of a bacteria

A. Maximum inhibitory concentration


196. Determinations which can directly the D. Facilitated
rate and extent of absorption
E. Ion pair
A. F
200. This term compares the extent of
B. Ka absorption of a test product (i.e.,generic)to a
standard or reference product,which is often
C. AUC an oral solution or an immediate-release
tablet ,but not an IV product.
D. Choices A and B
A. Absolute Bioavailability
E. Choices B and C
B. Relative Bioavailability
197. The FDA lists these products if they
pharmaceutical equivalents that are C. Intermediate Bioavailability
bioequivalent
D. AOTA
A. Pharmaceutical Equivalents
E. NOTA
B. Pharmaceutical alternatives
201. This principle states that the
C. Bioequivalent drug products concentration of the drug remainingin the
body at any time is added to the concentration
D. Therapeutic equivalents
remaining from the previous dose
E. Ion pair
A. Multiple dosing
198. This transport mechanism is formed
B. IV Bolus
through the complex of an organic anion of a
substance with a cation of medium or C. Superposition
membrane
D. Exponentiation
A. Passive diffusion
E. Potentiation
B. Convective transport
202. This measure of creatinine can be
C. Active expressed directly by measuring urine output
for 24hours and dividing this volume by
D. Facilitated
measurement of serum creatinine drawn at
E. Ion pair the midpoint of the 24-hour collection period

199. The transport mechanism happens A. Hepatic clearance


against concentration and electrochemical
B. Nephrotic clearance
potential
C. Creatinine clearance
A. Passive diffusion
D. Clearance
B. Convective transport
E. Cockcroft and Gault
C. Active
203. This transport mechanism is mediated by D. Unsaturated pharmacokinetics
means of carriers under expenditure of energy
and along a concentration gradient. E. NOTA

A. Passive diffusion 207. The primary goal of Phase 1 in drug


development
B. Convective
A. Safety of the drug candidate
C. Active
B. Efficacy of the drug candidate
D. Facilitated
C. Quality of the drug candidate
204. Vitamins A, D, E and K can be
transported via the mechanism D. Stability of the drug candidate

A. Pinocytosis E. AOTA

B. Active 208. The initial administration of an


investigational new drug to humans is usually
C. Passive Diffusion accomplished in

D. Facilitated A. Patients

E. Ion Pair B. Healthy subjects

205. This equation allows the determination of C. Rodents


the differences in creatinine clearance based
on patients’ weight ,age and gender D. Choices A and B

A. Jellife E. Choices B and C

B. Cockcroft and Gault 209. It is the only transport mechanism in


which the drug or compound does not have to
C. Noyes Whitney be in aqueous solution in order to be
absorbed
D. Fick’s
A. Endocytosis
E. NOTA
B. Passive diffusion
206. This is a result of saturation of a
metabolic carrier mediated system because C. Active
the enzyme involved in the metabolic process
can no longer D. Facilitated

Accept drug resulting in an increase in plasma E. Ion pair


drug concentration and possible toxicity
210. In the treatment design ,both an active
A. Linear pharmacokinetics and a placebo are given to the same subject

B. Nonlinear pharmacokinetics A. Time series design

C. Saturated pharmacokinetics B. Cohort


C. Crossover E. One-sixteenth

D. Placebo 214. The blood level time curve should have


at least hoe many blood level points during
E. Causal the absorptive phase?
211.If rats were the most sensitive species A. 2
,the starting dose for human acute dose
tolerance study would be________of the B. 3
largest no-observable-effect dose (mg/kg)from
the chronic rat toxicity study C. 4

A. One-third D. 5

B. One-sixth E. 6

C. One-eight 218. In phase 1 clinical trial the occurrence


of a dose limiting adverse event can be
D. One-tenth grounds for
A. Discontinuing the volunteer
E. One-sixteenth
B. Terminating the study
212. If the dogs were the most sensitive
C. Increasing sample size
species, the starting dose for human acute
dose tolerance study would be ________of D. Decreasing sample size
the largest no-observable-effect dose (mg/kg)
from the chronic rat toxicity study E. Choices B and D

A. One-third 219. These are sources of pharmacokinetic


variability, EXCEPT
B. One-sixth
A. Saturable first pass metabolism
C. One-eight
B. Diurnal variation
D. One-tenth
C. Autoinduction
E. One-sixteenth
D. Genetic polymorphism
212. If nonhuman primate were the most
sensitive species, the starting dose for human E. NOTA
acute dose tolerance study would be
________of the largest no-observable-effect 220. These studies are the first to include
dose (mg/kg) from the chronic rat toxicity patients with the disease intended for
study treatment

A. One-third A. Phase I

B. One-sixth B. Phase II

C. One-eight C. Phase III

D. One-tenth D. Phase IV
E. NOTA C. carcinogenicity

221. This part of Phase II clinical trial proves D. Mass balance studies
whether a drug works in patients
E. NOTA
A. Phase IIa
225. For the determination of current
B. Phase IIb pharmacokinetic parameters from blood level
curves, sampling should be continued for at
C. Phase IIIc least how many elimination half-lives?
D. Phase IVd A. 2
E. NOTA B. 3
222. This part of Phase II clinical trial C. 4
determines the best dose ,dose range,
titration, scheme, and dose interval. D. 5

A. Phase IIa E. 6

B. Phase IIb 226. This cultured cell model to predict drug


absorption is capable of secreting mucin,the
C. Phase IIIc primary agent of the mucous barrier in the
intestinal mucosa.
D. Phase IVd
A. HT-29
E. NOTA
B. T84
223. It is an increase in drug effect over time
despte constant drug concentrations at the C. Caco-2
effect site,which is manifested by a
counterclockwise hysteresis loop of plot of D. PAMPA
effect vs.concentraton
E. Mast cells
A. Tolerance
227.This computer simulation aids in the
B. Threshold identification of optimal dosage
regimen,evaluation of effective PK/PD models
C. Sensitization ,placebo response ,disease progression
,adverse effect development ,and ultimately
D. Downregulation
,the expedition of the decision making,
E. Side effect regulatory review ,and commercialization of
new drug processes.
224. The following are performed in phase II
clinical trials, EXCEPT A. Computer-aided clinical trial design

A. Reproductive toxicology B. GastroPlus

B. Placental transfer C. PK/PD Modelling

D. GC-MS
E. ELISA A. Phase I

228. This cultured cell model is valuable in B. Phase II


predicting the role of p-glycoprotein in
transport drugs C. Phase III

A. HT-29 D. Phase IV

B. T84 E. NOTA

C. Caco-2 233.This step is analyzing population


pharmacokinetics uses graphical and
D. PAMPA statistical techniques to reveal patterns in the
data ,identify potential outliers,and provide a
E. Mast cells diagnostic tool for confirming assumptions or
suggesting corrective action if assumptions
229. This cultured line allows for
are not met.
characterization of mucosal to serosal and
serosal to mucosal transport and can b=e A. Exploratory data analysis
used to study transcellular and paracellular
transport B. Population pharmacokinetic model
analysis
A. HT-29
C. Model validation
B. T84
D. Compartmental analysis
C. Caco-2
E. Abstract
D. PAMPA
234.Subcutaneous injection of octreotide
E. Mast cells acetate leads to symptomatic control in
patients with acromegaly and some gastro-
230. In this method to evaluate the transport
entero-pancreatic tumors .However to be fully
of drugs ,a small section of intestinal mucosa
effective ,a regimen of three times daily
is sandwiched between two chambers
dosing is warranted.To improve patient
containing buffer.
convenience and compliance ,octreotide
A. Clinical safety acetate has been reformulated into
microspheres of a biodegradable polumer.
B. Clinical efficacy This warrants

C. Clinical outcome A. Slow drug release of octreotide

D. Clinical surrogate B. Sustained release of octreotide

E. Clinical identity C. Single monthly intragluteal injection

232. For this particular [hase in the drug D. AOTA


development ,the drug candidate is tested
under conditions and in patients more closely E. NOTA
resembling those who would be encountered
235. Intragluteal injection is a form of
if the drug were approved
A. Intravenous injection B. ANDA

B. Subcutaneous injection C. NDA

C. Intramuscular injection D. Choices B and C

D. Intrathecal injection E. NOTA

E. NOTA 239. This refers to the rate and extent to


which the active ingredient or active moiety is
236.This is the step in population absorbed from the drug product and becomes
pharmacokinetics evaluates the predictive available at the site of action
ability of the model by testing it agaisnt a
different data set ,either data from another A. Bioequivalence
study or data from the study in question which
a portion of (e.g.20%)of the total data set has B. Bioavailability
been set aside for just such purposes
C. Biotransformation
A. Exploratory data analysis
D. Biotechnology
B. Population pharmacokinetic model
E. Biosimilar
analysis
240. Drug products that contain identical
C. Model validation
amounts of active ingredient ,i.e.,the same
D. Compartmental analysis salt or ester of the same therapeutic moiety ,in
identical dosage forms ,but not necessarily
E. Abstract containing the same inactive ingredients

237. Other than the intended disease to be A. Therapeutic alternatives


treated ,separate studies are usualy
conducted for the following conditions during B. Pharmaceutical alternatives
Phase III clinical trial to examine the effects on
C. Bioequivalent
these factors on pharmacokinetics
D. Pharmaceutical equivalent
A. Renal disease
E. Pharmacotherapeutic alternative
B. Hepatic disease
241. Drug products that contain identical
C. Elderly populations
therapeutic moiety or its precursor, but not
D. Pediatric populations necessarily in the same amount or dosage
form or as the same salt or ester
E. AOTA
A. Therapeutic alternatives
238. This is the document through which the
active ingredient or active moiety is absorbed B. Pharmaceutical alternatives
from the drug product and becomes available
C. Bioequivalent
at the site of action
D. Pharmaceutical equivalents
A. IND
E. Pharmacotherapeutic alternative 245.It is a measure of the extent of drug
absorption
242. This drug product category can only be
met if the drug products are pharmaceutical A. Half-life
equivalents and if they can be expected to
have the same clinical effect and safety profile B. Volume of Distribution
when administered to patients under the
C. AUC
conditions specified in the labeling
D. Cmax
A. Therapeutic equivalents
E. tmax
B. Pharmaceutical alternatives
246. This method of assessing the
C. Bioequivalence
bioavailabilty of a drug can only be used if
D. Pharmaceutical equivalence urinary excretion is the main pathway of
elimination
E. Pharmacotherapeutic alternative
A. Urinary excretion data
243. This refers to the absence of a significant
difference in the rate and extent to which the B. Plasma data
active ingredient or active moiety in
C. Serum data
pharmaceutical equivalents for
pharmaceutical alternatives becomes D. Half-life
available at the site of action when
administered at the same molar dose under E. Volume of distribution
similar conditions in an appropriately designed
247. Gastric emptying depends on the
study
following factors,EXCEPT
A. Therapeutic equivalence
A. Viscosity of the stomach
B. Pharmaceutical alternatives
B. pH of the stomach
C. Bioequivalence
C. Volume of liquid intake
D. Pharmaceutical equivalents
D. Disease state
E. Pharmacotherapeutic alternative
E. pKa of the drug
244. Bioavailability and /or bioequivalence are
248. This occurs when absorbed drug passes
essential for the following situations ,EXCEPT
directly through the liver before reaching the
A. For all new molecular entities systemic circulation after oral administration.

B. For a new dosage form of a drug A. First-pass metabolism

C. For a new salt or ester of a drug B. Intestinal metabolism

D. For a new indication C. Hydrolysis of the drug in the stomach

E. AOTA D. Transported by p-glycoprotein


E. Complexation A. Dialysis

249. This is the usual research design for B. Ultracentrifugation


conducting bioavailabilty and bioequivalence
studies C. Agar plate test

A. two-formulation , two-period ,two- D. AOTA


sequence non-replicate crossover
E. NOTA
design
253. Drug binding to protein can be
B. two-formulation, three-period ,three-
considered as a
sequence non-replicate crossover
design A. Reversible process

C. two- formulation, two-period ,three- B. Irreversible process


sequence non-replicate crossover
design C. Linear

D. two-formulation ,two-period ,two- D. Nonlinear


sequence non-replicate cohort design
E. Saturated
E. AOTA
254. These are the known importance of drug-
250. This occurs when the drug is protein binding
metabolized in the intestine itself or during the
A. Buffer
passage through the intestinal wall
B. Transport
A. First-pass metabolism
C. Protection
B. Intestinal metabolism
D. Choices A and B
C. Hydrolysis of the drug in the stomach
E. Choices B and C
D. Transported by p-glycoprotein
255. This physiological importance of drug-
E. Complexation
protein binding is reflected by its capacity to
251. The main protein fraction blood plasma is maintain a relatively constant concentration of
free drug over a long period of time
A. Histidine
A. Buffer function
B. Arginine
B. Transport function
C. Proline
C. Protection function
D. Lysine
D. Choices A and B
E. Albumin
E. Choices B and C
252. The extent of protein binding is
determined in vitro by the following methods,
EXCEPT
256. This physiological importance drug- E. NOTA
protein binding is reflected with drugs of low
solubility in water 260. Bound drugs cannot be metabolized and
are not excreted, therefore
A. Buffer function
A. Increases urinary excretion of drugs
B. Transport function
B. Increases elimination half-life of drugs
C. Protection function
C. Decreases binding of hydrophilic
D. Choices A and B drugs

E. Choices B and C D. Increases glomerular filtration

257. Free drug concentration ____ of plasma E. AOTA


binding, but is ______ on tissue binding
261. Biotransformation converts drug into
A. Independent , dependent
A. Polar
B. Dependent , independent
B. Water soluble
C. Dependent , dissociative
C. Ionized structures
D. Dissociative , Independent
D. AOTA
E. AOTA
E. NOTA
258.This condition is found in patients with
burns , cancer, cardiac failure , cystic fibrosis, 262. The biotransformation of Protonsil results
liver impairment, and enteropathy. to____ which is a more pharmacologically
active compound.
A. Hyperalbubinemia
A. Imipramine
B. Hypoalbuminemia
B. Methyldopa
C. Hypochondria
C. Sulphanilamide
D. Hyperchondria
D. Pyridine
E. NOTA
E. Phenacetin
259. This condition is found in patients with
benign tumour, myalgia, neuroses, 263. The oxidation of chloral hydrate
psychoses, schizophrenia, and paranoia produces

A. Hyperalbubinemia A. Pentobarbital

B. Hypoalbuminemia B. Phenobarbital

C. Hypochondria C. Acetic acid

D. Hyperchondria D. Dichloroacetic acid


E. Trichloroacetic acid 268. This metabolism phase reaction is
responsible for the formation of the final
264. The principal site of drug metabolism is metabolic product of the drug to be excreted
the
A. Phase 1
A. Kidney
B. Phase 2
B. Liver
C. Phase 3
C. Lungs
D. Phase 4
D. Heart
E. Phase 5
E. Intestine
269. Kernicterus is a condition which results
265. The cytochrome enzymes originate from from
A. Cytoplasm A. Inability to conjugate albumin
B. Cell membrane B. Inability to conjugate bilirubin
C. Golgi apparatus C. Inability to conjugate acetic acid
D. Microsomes D. Inability to conjugate glucose
E. Ribosome E. Inability to conjugate lipids
266.The following are phase 1 270. A one month old infant already develops
biotransformation reactions,EXCEPT the following metabolic processes, EXCEPT
A. Oxidation A. Sulfation
B. Reduction B. Conjugation
C. Hydrolysis C. Oxidation
D. Deamination D. Acetylation
E. methylation E. Glucoronidation
267. The following are phase 2 271. Phenobarbital and hexobarbital are
biotransformation reactions, EXCEPT stimulated in their metabolism by auto and
foreign induction .This phenomenon is termed
A. Dealkylation
A. Link-induction
B. Glycine conjugation
B. Time series induction
C. Acetylation
C. Scratchard induction
D. Ethereal sulphate conjugation
D. Cross induction
E. Choices B and C
E. Repulsive induction
272. If a drug stimulates the rate of D. Locations
metabolism of another drug ,this phenomenon
is called E. Models

A. Auto-induction 276. A blood level versus time curve for an


extravascular administration can be fitted to a
B. Foreign-induction
A. One compartment model
C. Cross-induction
B. Two compartment model
D. Anti-induction
C. Three compartment model
E. Focus-induction
D. Multi compartment model
273. First pass effect cannot be observed in
the following routes of administration,EXCEPT E. NOTA

A. Oral 277. A blood level versus time curve for an


intravascular administration can be fitted to a
B. Buccal
A. One compartment model
C. Intravenous
B. Two compartment model
D. Sublingual
C. Three compartment model
E. Choices A and B
D. Multi compartment model
274. It is a hypothetical structure which can be
used to characterize wih reproducibility the E. NOTA
behaviour and the fate of drug in biological
278. This compartment model describes a
systems
situation in which a drug entering the body
A. Concepts distributes instantly between the blood and
other body fluids or tissues
B. Constructs
A. One compartment model
C. Compartments
B. Two compartment model
D. Locations
C. Three compartment model
E. Models
D. Multi compartment model
275. It is an entity which can be described by
a definite volume and a concentration of drug E. NOTA
contained in the volume
279. If a drug entering the body does not
A. Concepts instantly distributes instantly between the
blood and other body fluids or tissues it
B. Constructs eventually reaches, this can be described by

C. Compartments A. One compartment model


B. Two compartment model 283. This pharmacokinetic parameter gives
the speed at which a drug enters a
C. Three compartment model compartment, distributes between a central
and peripheral compartments and is
D. Multi compartment model
eliminated from the systemic circulation.
E. NOTA
A. Half-life
280. This body fluids or tissues which are in
B. Volume of distribution
equilibrium with the circulatory system
comprise the C. Rate constant
A. Central compartment D. AUC
B. Peripheral compartment E. Cmax
C. Tissue compartment 284. Alcohol in the body is eliminated by
D. Enteral compartment A. Zero-order reaction
E. Deep compartment B. First-order reaction
281. Those body fluids or tissues into which C. Third-order reaction
the drug distributes slowly comprise the
D. Fourth-order reaction
A. Central compartment
E. NOTA
B. Peripheral compartment
285. Dose dependent kinetics can occur due
C. Tissue compartment to the following situations, EXCEPT
D. Enteral compartment A. Over loading of metabolic processes
when large doses are given
E. Deep compartment
B. Competition for one type of metabolic
282. To know whether a one or two
process by two drugs
compartment models applies, the terminal
slope of the line is back-extrapolated to the C. When active transport mechanisms
ordinate. If no concentration-time data points are overloaded
lie above the line, this model is applicable
D. AOTA
A. One compartment model
E. NOTA
B. Two compartment model
286. This is the rate constant describing the
C. Three compartment model loss of unchanged drug from the systemic
circulation by either excretion or metabolism
D. Open Multi compartment model
A. Absorption rate constant
E. NOTA
B. Distribution rate constant
C. Elimination rate constant A. Different drug release rate from
dosage form
D. Excretion rate constant
B. Disease
E. Metabolism rate constant
C. Viscosity of gastric content
287. If a drug is given extravascularly ,this
rate constant describes the rate of input of D. Fasting or fed conditions
drug into systemic circulation.
E. AOTA
A. Absorption rate constant
291. In obesity, the volume of hydrophilic
B. Distribution rate constant drugs is _____ expected from the body weight

C. Elimination rate constant A. Higher than

D. Excretion rate constant B. Lower than

E. Metabolism rate constant C. Deeper than

288. With this drug product ,a solution results D. Insufficient data


in a smaller total amount of drug absorbed
than when it is given in the form of capsules E. NOTA
and tablets.
292. In the edematic patients, the volume of
A. Aspirin distribution of hydrophilic drug is ___expected
from the body weight
B. Paracetamol
A. Higher than
C. Nifedipine
B. Lower than
D. Griseofulvin
C. Deeper than
E. Metoprolol
D. Insufficient data

E. NOTA
289. The following are methods to estimate
the absorption rate constant , EXCEPT 294.If the volume of distribution in an adult is
approximately 5 liters,it means that the drug is
A. Cmax- Truncated AUC method in

B. Nomogram method A. Circulatory system

C. Absorption time method B. Extracellular fluid

D. Ritschel method C. Intracellular fluid

E. NOTA D. Whole body fluid

290. Absorption rate constant may be different E. Fats


due to
295. If the volume of distribution in an adult is 299. These are the compounds which are
approximately between 25-30 liters, the drug filtered through the glomeruli only and are
is distributed in the used as test substances for kidney function
test to determine the glomerular filtration rate
A. Circulatory system
A. Inulin
B. Extracellular fluid
B. Creatinine
C. Intracellular fluid
C. Reserpine
D. Whole body fluid
D. Choices A and B
E. Fats
E. Choices B and C
296. If the volume of distribution in an adult is
approximately 40 liters, the drug is distributed 300. This test is used for determination of
in the liver’s capacity for active transport and biliary
excretion
A. Circulatory system
A. Phenolphthalein Test
B. Extracellular fluid
B. Iodosulpthalein Test
C. Intracellular fluid
C. Bromosulhthalein Test
D. Whole body fluid
D. Arabinogalactose Test
E. Fats
E. Methylated Resin Test
297. Volumes of distribution can be estimated
in vitro by

A. Apparent partition coefficients

B. Extent of protein binding

C. pKa and pH ratio

D. Choices A and B

E. Choices B and C

298. The most important organ for excretion


is

A. Heart

B. Lungs

C. Kidney

D. Liver

E. Intestine

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