Biopharmaceutics and Pharmacokinetics (VIOLET PACOP)

1. It is the ability of a drug to exist in two or more crystalline form:

A. Chirality
B. Polymorphism
C. Stereoisomerism
D. A and C
E. None of these
2. Arrange the following dosage forms from highest to lowest dissolution rate:
I. Solution III. Suspension
II. Capsule IV. Tablet
A. I, II, III, IV
B. I, III, II, IV
C. IV, III, II, I
D. IV, II, III, I
E. None of these
3. All of the following statements aretrye regarding particle size of a drug, EXCEPT:
A. Reducing the particle size can decrease the surface are the molecule exposed to the solvent.
B. Reduction of paticle size can be achieved by micronisation using jet mill, spray drying and air attrition
methods.
C. The dissolution of some drugs available in the market has been improved by reducing the particle
size.
D. Reducing the particle size of a drug may increase drug absorption.
E. None of these
4. Which of the following may increase drug dissolution rate?
I. Too much binder
II. Insoluble diluents
III. High amount of lubricants
A. I only
B. I and II
C. II and III
D. I, II, AND III
E. None of these
5. Which of the following is not true regarding the purpose of tablet coating?
A. Improves palatability
B. Improve aesthetic value of tablet
C. Improve stability
D. Improve in-vivo degradation
E. None of these
6. A surface active agent that facilitates the absorption of lipophilic drug or water insoluble drugs
A. Bile
B. Albumin
C. Renin
D. Gastric acid
E. None of these
7. Phase 2 metabolism that protects the body against chemically reactive metabolites
A. Sulfate conjugation
B. Glutathione conjugation
C. Methylation
D. Acetylation
E. Glycine conjugation
8. All of the following listed below are processes of drug excretion, EXCEPT:
A. Glomerular filtration
B. Active secretion
C. Tubular secretion
D. Tubular reabsorption
E. None of these
9. It is the basic functional unit of the kidney
A. Glomerulus
B. Loop of henle
C. Nephron
D. Collecting tubule
 E. None of these
10. Creatinine clearance of a patient with kidney failure
A. 60-89 mL
B. 30-59 mL
C. 15-29 mL
D. <15 mL
E. None of these
11. Which of the following drugs listed belowwill increase its clearance at alkaline urine?
I. Amphetamine
II. Imipramine
III. Barbiturates
IV. Salicylic acid
A. I and II C. III and IV E. None of these
B. II and III D. All of these
12. Which of the following correctly describes ion trapping
A. Changing the pH of urine used to facilitate the elimination of drug that proved to be toxic to a patient
or has been taken in overdosed amount
B. Administration of acidic drug to neutralize am alkaline poison in the stomach
C. Alkalinizing the urine to facilitate excretion of weakly basic drugs
D. A and C
E. None of these
13. Discipline that applie Pharmacokinetic concepts and principles in humans in order to design individualized
dosage regimens that optimize the therapeutic response of a medication while minimizing the chance of an
adverse drug reaction
A. Clinical toxicology
B. Clinical pharmacy
C. Clinical Pharmacokinetics
D. Pharmacotherapeutics
E. None of these
14. Chemical conversion of the drug molecule, usually by an enzymatically mediated reaction, into another
chemical entity referred to as a metabolite
A. Absorption
B. Distribution
C. Metabolism
D. Excretion
E. None of these
15. Volume of serum or blood completely cleared of the drug per unit time
A. Volume of distribution
B. Clearance
C. Elimination
D. Plasma concentration
E. None of these
16. Hypothetical volume that relates drug serum concentrations to the amount of drug in the body
A. Volume of distribution
B. Clearance
C. Drug Elimination
D. Plasma concentration
E. None of these
17. All of the following factors affects the volume of distribution of drug, EXCEPT
A. Volume of blood
B. Size of various organs and tissue in the body
C. Protein binding
D. Physicochemical properties of drug
E. None of these
18. The fraction of administered dose that is delivered to the systemic circulation is known as the
A. Loading of dose
B. Maintenance dose
C. Bioavailability
D. Active dose
E. None of these
19. Below is an example of
A. Dose response curve
 B. Plasma level time curve
C. Quantal dose response curve
D. A and B
E. None of these
20. After the first dose of gentamicin is given to a patient with renal failure the following serum concentrations are
obtained
Time after drug administration(h) Concentration (mcg/mL)
1 7.7
24 5.6
48 4.0

A. 30 hours and 0.0123/hr

B. 45 hours and 0.0146/hr
C. 55 hours and 0.0129/hr
D. 50 hours and 0.0139/hr
E. None of these
21. All of the following are true regarding the rate of drug distribution, EXCEPT:
A. The rate of drug distribution will be faster in highly perfuse tissues
B. The blood brain barrier(BBB) prevents the distribution of many polar compounds in the blood to the
brain tissues
C. Only the lipophilic compounds can distribute across BBB by passive diffusion
D. The equilibrium between the drug in the blood and the drug in highly perfused tissues is achieved
slower than the equilibrium between the drug in blood and the poorly perfused tissues
E. Non of these
22. Which of the following factors affect drug distribution?
1. Blood perfusion
2. Tissue composition
3. Plasma protein binding
4 Physicochemical properties of drug
A. 1 only
B. 1 and 2
C. 2 and 3
D. 1, 2, 3, 4
E. None of these
23. Technique in the determination of drug plasma protein binding that utilize a special dialysis chamber that is separated
into two halves by a semipermeable membrane that allows the transfer of the free drug molecule but not the drug bound
to protein.
A. Ultrafiltration D. A and B
B. Equilibrium dialysis E. None of these
C. Hemodialysis
24. Which of the following statements are true regarding volume of distribution (Vd) ?
A. Relates the amount of absorbed drug D. Drugs that are highly bound to plasma
with the amount of eliminated drug. proteins have low Vd
B. Total volume of the drug absorbed E. All of these
C. Drugs that are highly distributed
into the tissues have low Vd
25. For nos. 25-29:
A single IV bolus of drug was administered to a patient and the amount of drug in the body was determined at different
time points after drug administration:
Time (h) Amount (mg)
0.5 396
1 315
2 198
4 79
8 12.4
12 1.96

What is the order of the elimination process of this drug?

A. Zero order kinetics C. Second order kinetic E. None of these
B. First order kinetics D. A or B
26. What is the rate constant for elimination process?
A. 0.5712/hr D. 0.4617/hr
B. 0.3789/hr E. 0.2341/hr
C. 0.6234/hr
27. What is the dose of drug administered to this patient?
A. 500 mg D. 100 mg
B. 300 mg E. 700 mg
C. 200 mg
28. Calculate the amount of drug in the body 10h after administration
A. 5.32 mg D. 3.22 mg
B. 3.45 mg E. 6.55 mg
C. 4.94 mg
29. What is the half-life of the drug immediately after drug administration?
A. 3 hrs D. 1.5 hrs
B. 5 hrs E. 3.5 hrs
C. 2.5 hrs
30. For nos. 30-31
The following are the pharmacokinetic parameters for a group of drugs
Drug Vd (L/Kg) Elimination rate constant (h-¹)
Theophylline 0.45 0.11
Ampicillin 0.3 0.6
Quinidine 3 0.08
Gentamicin 2 0.08
Digoxin 20 0.01
Which drug has the highest Cl?
A. Theophylline D. Gentamicin
B. Ampicillin E. Digoxin
C. Quinidine
31. Which drug has the lowest Cl?
A. Theophylline D. A and B
B. Ampicillin E. B and C
C. Quinidine
32. Elimination of a drug refers to:
I. Excretion of unchanged drug in the urine
II. Renal excretion of drug
III. Uptake of a drug from the blood into the liver
IV. Metabolism of drug in the liver
V. Distribution of drug into fat
A. I and II D. III and V
B. II and III E. None of these
C. II and IV
33. The loading dose of a drug is determined by:
I. Drug clearance
II. Elimination rate
III. Target plasma drug concentration
IV. Volume of distribution
V. Duration of drug effect
A. I and II C. III and IV E. All of these
B. II and III D. IV and V
34. Half-life:
I. Increases as the clearance increases
II. Decreases as the volume of distribution increases
III. Decreases as clearance increases
IV. Increases as volume of distribution increases
V. Increases as the elimination rate increases
A. I and II D. IV and V
B. II and III E. None of these
C. III and IV
35. After a single dose of a drug which has a half-life of 12 hours, what percentage of the dose is still in the body after 1
day?
A. 87.5% D. 25%
B. 75% E. 12.5%
C. 50%
36. Which of the following routes of administration completely avoid first pass clearance?
I. Buccal
II. Sublingual
III. Rectal
IV. Oral
V. Transdermal
A. I and II D. I, II and V
B. I, II and III E. III and V
C. I, II and IV
37. The term linear pharmacokinetic means:
I. A plot of drug concentration vs. time is linear
II. Half-life increases proportionally with dose
III. A constant amount of drug is eliminated per unit time
IV. Clearance is proportional to the dose
V. Steady state drug concentration is proportional to the dose
A. I only D. II and IV
B. I and II E. V only
C. III only
38. Which of the following process are saturable and can result in non-linear pharmacokinetics?
I. Drug metabolism
II. Glomerular filtration
III. Protein binding
IV. Renal tubular secretion
A. I only D. I, III and IV
B. II, III and IV E. None of these
C. I, II, and IV
39. The study of the time course of drug absorption, distribution, metabolism and excretion is called:
A. Pharmacodynamics D. Kinetics Homogeneity
B. Drug concentration E. Biopharmaceutics
C. Pharmacokinetics
40. The application of pharmacokinetic principles to the safe and effective therapeutic management of drugs in and
individual patient is known as:
A. Pharmacodynamics D. Biopharmaceutics
B. Pharmacokinetics E. None of these
C. Clinical pharmacokinetics

41. Pharmacodynamics refers to the relationship of drug:

A. Dose to drug concentration in plasma D. Dose to drug effect
B. Dose to drug concentration at the E. None of these
receptor site
C. Concentration to drug effect
42. The EC50 refers to the drug concentration at which:
A. One-half the maximum response is achieved. D. Minimum effective concentration
B. The maximal effect is achieved. E. Minimum toxic concentration
C. Tolerance is likely to be observed.
43. An example of a situation that would not support therapeutic drug concentration monitoring with plasma drug
concentrations would be one in which:
A. A wide variation in plasma drug concentrations D. A and B
is achieved in different patients given a standar
drug dose.
B. The toxic plasma concentration is many E. B and C
times the therapeutic concentration range.
C. Correlation between a drug's plasma
concentration and therapeutic response
is good.
44. The most commonly used model in clinical pharmacokinetic situations is the:
A. One-compartment model D. A and C
B. Two-compartment model E. All of these
C. Multicompartment model
45. Instantaneous distribution to most body tissues and fluids is assumed in
which of the following models?
A. One-compartment model D. A and C
B. Two-compartment model E. All of these
C. Multicompartment model
46. For a drug that has first-order elimination and follows a one-compartment model,
which of the following plots would result in a curved line?
A. Plasma concentration versus time D. A and B
B. Natural log of plasma concentration E. B and C
versus time
C. Common log of plasma concentration
versus time
47. For the body fluid compartments below, rank them from the lowest volume to the highest, in a typical 70-kg person.
A. Plasma < extracellular fluid < intracellular D. Total body water < plasma <
fluid < total body water intracellular fluid < extracellular fluid
B. Extracellular fluid < intracellular fluid < E. None of these
plasma < total body water
C. Intracellular fluid < extracellular fluid <
plasma < total body water
48. All of the following are true regarding clearance, EXCEPT
I. The unit for clearance is volume/time
II. Total body clearance is the sum of clearance by the kidneys, liver,
and other routes of elimination
III. To determine drug clearance, we must first determine whether a drug
best fits one or two compartment model
A. I only D. III only
B. II only E. None of these
C. II and III
49. With a drug that follows first-order elimination, the amount of drug eliminated per unit time:
A. Remains constant while the fraction of drug D. B or C
eliminated decreases
B. Decreases while the fraction of drug E. None of these
eliminated remains constant.
C. Increases while the fraction of drug
eliminated remains constant.
50. Which of the following is a proper unit for 1st order elimination rate constant?
A. Minutes D. mg/L
B. mg/minute E. A and B
C. hr¹
51. Trapezoidal rule method is used in the computation of:
A. K D. Vd
B. T½ E. Cl
C. AUC
52. Which of the following are true regarding AUC?
I. Can be used to determine drug clearance
II. Reflects the amount of drug absorbed
III. Dose administered divided by the drug's clearance
A. I only D. All of these
B. I and II E. None of these
C. II and III
53. Gentamicin has a t½ of:
A. 39 hours C. 7 hours E. 2-3 hours
B. 22 hours D. 20 hours
54. The time between administration of doses is the:
A. Onset time D. tmax
B. Dosing range E. None of these
C. Dosing interval
55. The point at which the amount of drug administered over a dosing interval equals the amount of drug being eliminated
over that same period and is totally dependent on the elimination rate constant
A. Rate constant D. Absorption phase
B. Steady state E. None of these
C. Elimination
56. Steady-state concentration can be increase by adjusting which of the following parameters?
I. t½
II. Dose administered
III. Dosing interval
A. I only D. All of these
B. II only E. None of these
C. II and III
57. To predict the plasma concentration of a drug at any time t after n number of doses, we therefore need to know which
among the following values?
I. Drug dose
II. Volume of distribution
III. Elimination rate constant
IV. Dosing interval
A. I and II D. All of these
B. II and III E. None of these
C. III and IV

58. This method of giving multiple doses by infusion at specified intervals is called:
A. IV bolus D. A and B
B. Intermittent IV infusion E. None of these
C. Multiple infusion
59. For a drug regimen, if the elimination rate (K) of a drug is reduced while volume of distribution, drug dose, and dosing
interval remain constant, the peak and trough concentrations will:
A. increase D. A or B
B. decrease E. None of these
C. remains the same
60. Method used in toxicokinetics and for the extrapolation of therapeutic drug doses in humans from nonclinical animal
drug studies.
A. Interspecies scaling D. A and C
B. Toxicological extrapolation E. None of these
C. Linear analysis
61. A condition in which glomerular filtration is impaired or reduced, leading to accumulation of excessive fluid and blood
nitrogenous products in the body.
A. Cystitis D. Hypovolemia
B. Uremia E. None of these
C. Pancreatitis
62. Common cause of kidney failure, EXCEPT:
I. Pyelonephritis
II. Hypotension
III. Diabetes mellitus
IV. Nephroallergens
A. I only C. II only E. IV only
B. I and II D. III and IV
63. A fructose polysaccharide used as a standard reference for the measurement of GFR:
A. Chitosan D. Chitin
B. Inulin E. A and B
C. Cellulose
64.
A. Creatinine clearance D. Detection of uric acid in urine
B. Measurement of blood urea nitrogen E. None of these
C. Detectionof kidney stone
65. The normal blood urea nitrogen for a patient is:
A. 1-10 mg/dL D. 30-40 mg/dL
B. 10-20 mg/dL E. 40-50 mg/dL
C. 20-30 mg/dL
66. Which of the following are true regarding creatinine clearance?
I. Volume of plasma cleared of creatinine per unit time
II. Calculated directly by dividing rate of urinary excretion of creatinine by the
patient's serum creatinine concentration
III. Creatinine clearance is expressed in mL/min and serum creatinine
concentration in mg/dL or mg%
A. I only D. All of these
B. I and II E. None of these
C. II and III
67. Stage of kidney disease with creatinine clearance of 30-59 mL/min
A. Stage 1 D. Stage 4
B. Stage 2 E. Stage 5
C. Stage 3
68. Patients with mild decrease in glomerular filtration rate has a creatinine clearance of:
A. > 90 mL/min D. 15-29 mL/min
B. 60-89 mL/min E. < 15 mL/min
C. 30-59 mL/min
69. An artificial process in which the accumulation of drugs or waste metabolites is removed by diffusion from the body
into the specialized fluid
A. Dialysis D. A and C
B. Hemodiffusion E. None of these
C. Ultrafiltration
70. Uses a dialysis machine and filters blood through an artificial membrane. It requires access to the blood vessels to
allow the blood to flow to the dialysis machine and back to the body.
A. Hemodialysis D. Hemoperfusion
B. Peritoneal dialysis E. Hemofiltration
C. Continuous ambulatory peritoneal dialysis
71. The process of removing drug by passing the blood from the patient through an adsorbent material and back to the
patient:
A. Hemodialysis D. Hemoperfusion
B. Peritoneal dialysis E. Hemofiltration
C. Continuous ambulatory peritoneal dialysis
72. A process by which fluids, electrolytes, and small molecular weight substances are removed from the blood by means
of low pressure flow through hollow artificial fibers or flat plate membranes
A. Hemodialysis D. Hemoperfusion
B. Peritoneal dialysis E. Hemofiltration
C. Continuous ambulatory peritoneal dialysis

73. Which of the following are true regarding dosing consideration on patients with hepatic impairments?
I. All liver diseases affect the pharmacokinetics of the drugs to the same extent
II. Drug-protein binding may be altered due to attention in hepatic synthesis o
albumin.
III. Metabolism of drugs with high intrinsic clearance may be impaired.
IV. Drugs with a wide therapeutic range will be less affected by moderate hepatic
impairment.
A. I, II and III D. All of these
B. II, III and IV E. None of these
C. I, II and IV
74. Hepatic metabolic marker found in liver and many other tissues, including cardiac and skeletal muscles:
A. ALT D. SGPT
B. ALP E. A and D
C. AST
75. Hepatic metabolic marker that is only specific on liver:
A. ALT D. SGPT
B. ALP E. A and D
C. AST
76. Patients having liver disease have the following pharmacokinetic characteristics except:
A. Increase drug protein binding D. Increase Vd for hydrophilic drugs
B. Decreased drug metabolism E. None of these
C. Increase drug half-life
77. Pregnancy category wherein there is a positive evidence of risk in taking the drug but the benefit in taking the drug
outweighs the risk.
A. Category A D. Category D
B. Category B E. Category X
C. Category C
78. Pharmacokinetic behavior of geriatric patients:
I. Impaired absorption
II. Slow metabolism
III. Prolonged drug half-life
A. I only D. All of these
B. I and II E. None of these
C. II and III
79. All of the following are true regarding capacity limited excretion, EXCEPT:
A. Passive secretion and passive reabsorption D. A and B
are saturable processes
B. Saturated tubular secretion decreases ClR E. None of these
C. Saturated tubular reabsorption increases ClR
80. Example of a drug that exhibits saturable protein binding:
I. Nicardipine
II. Propranolol
III. Amoxicillin
A. I only D. All of these
B. I and II E. None of these
C. II and III
81. The following parameters listed below can be adjusted when designing a multiple dosage regimen except:
A. Size of dose administered D. All of these
B. Drug protein binding E. None of these
C. Dosing interval
82. The initial step in the elimination process via the kidney occurs in the:
A. Glomerulus D. Proximal tubule
B. Nephron E. None of these
C. Distal Tubule
83. The capacity of the body to eliminate the drug after it has reached the general circulation is reflected by the:
A. Total clearance D. AUC
B. Volume of distribution E. None of these
C. Biliary recycling
84. The process of drug metabolism and excretion constitute:
A. Deposition D. Biotransformation
B. Elimination E. Clearance
C. Accumulation
85. True about enzyme induction:
I. Low therapeutic levels of active drug (decrease drug efficacy)
II. Prodrug (decrease in efficacy)
III. Toxic metabolite (decrease in toxicity)
A. I only D. IV only
B. I and II E. None of these
C. II and III
86. Which of the following enzyme(s) is/are utilized in Phase I Metabolism?
I. CYP3A4
II. UDP glucuronosyl acyltransferase
III. N-acetyltransferase
A. I only C. II and III E. All of these
B. I and II D. I and III
87. Which of the following enzyme(s) is/are utilized in Phase II Metabolism?
I. CYP3A4
II. UDP glucuronosyl acyltransferase
III. N-acetyltransferase
A. I only C. II and III E. All of these
B. I and II D. I and III
88. A lipophilic medicinal agent has the following property:
A. Low ability to penetrate through the D. High reabsorption in renal tubules
cell membrane lipids
B. Penetrate through membranes by E. None of these
means of endocytosis
C. Low permeatation through the
blood-brain barrier
89. The plasma level time curve below follows what compartment model?
A. One compartment D. A or B
B. Two compartment E. None of these
C. Three compartment
90. Two compartment model:
I. Resolves the body into central and peripheral compartment
II. Peripheral compartment is composed of less perfused organs
muscle, fat and lungs.
III. The difference from one compartment model is that the drug
does achieve instantaneous distribution.

92. Drug Clearance:

I. A measure of drug elimination from the body
II. Drug clearance refers to the volume of plasma fluid that is cleared of drug per unit
III. Clearance may also be considered as the fraction of drug removed per unit time
multiplied by the rte constant
A. I only D. I and III
B. I and II E. None of these
C. II and III
93. Volume of distribution:
I. The theoretical volume that would be necessary to contain the total amount of an
administered drug at the same concentration that is observed in the plasma
II. Indicator of the extent of drug distribution into body fluids and tissues
III. Important in calculation of drug dose
A. I only D. I and III
B. I and II E. All of these
C. II and III
94. Determine the half-life of an antihypertensive drug if it appears to be eliminated from the body at a rate constant of
0.07/hr. Assume frist-order kinetics occurs.
A. 12 hours D. 4 hours
B. 9.9 hours E. 1.5 hours
C. 7 hours
95. The amount of drug A is decreasing at a rate that is proportional to the amount of drug A
A. Non-linear pharmacokinetics D. Enzyme kinetics
B. 1st order E. B or C
C. Zero order
96. Procedures employing test apparatus and equipment without involving laboratory animals or humans.
A. In-vivo D. Ex-vivo
B. In-silico E. All of these
C. In-vitro
97. Release of the drug substance from the drug product either for local drug action or for drug absorption into the plasma
for systemic therapeutic activity
A. Drug product performance D. Pharmacodynamics
B. Pharmacokinetics E. A and B
C. Biopharmaceutics
98. Biopharmaceutics examines the interrelationship of the following, EXCEPT:
I. Physical/chemical properties of the drug
II. The dosage form (drug product) in which the drug is given
III. Route of administration
IV. Rate and extent of systemic drug absorption.
A. I only D. IV only
B. II only E. None of these
C. II and III
99. Oral, topical, parenteral, transdermal, inhalation are examples of:
A. Dosage form D. A and B
B. Route of administration E. None of these
C. Therapeutic effect
100. Application of pharmacokinetic principles to the design, conduct and interpretation of drug safety evaluation studies
and in validating dose related exposure in animals.
A. Toxicokinetics D. Pharmacokinetics
B. Biopharmaceutics E. A and B
C. Pharmacodynamics
101. Include sampling blood, spinal fluid, synovial fluid, tissue biopsy, or any biologic material that requires parenteral or
surgical intervention in the patient.
A. In-vitro methods D. Ex-vivo methods
B. Invasive methods E. None of these
C. Non-invasive methods
102. Include sampling of urine, saliva, feces, expired air, or any biologic material that can be obtained without parenteral
or surgical intervention.
A. In-vitro methods D. Ex-vivo methods
B. Invasive methods E. None of these
C. Non-invasive methods
103. The noncellular liquid fraction of whole blood and contains all the proteins including albumin
A. Platelet D. Fibrin
B. Serum E. None of these
C. Plasma
104. Liquid obtained from whole blood after the blood is allowed to clot and the clot is removed. Does not contain the
cellulr elements, fibrinogen, or the other clotting factors from the blood.
A. Platelet D. Fibrin
B. Serum E. None of these
C. Plasma
105. Indicate the part of a plasma level-time curve
A. tmax D. MEC
B. Therapeutic range E. MTC
C. Cmax
106. Indicate the part of a plasma level-time curve
A. Cmax C. Onset time E. Therapeutic range
B. tmax D. AUC
107. Indicate the part of a plasma level-time curve
A. Duration of action D. MTC
B. Onset time E. t max
C. MEC
108. Indicate the part of a plasma level-time curve
A. Duration of action D. MTC
B. Onset time E. t max
C. MEC
109. Indicate the part of a plasma level-time curve
A. Cmax D. MTC
B. tmax E. AUC
C. MEC
110. Indicate the part of a plasma level-time curve
A. tmax D. Duration of action
B. Cmax E. MEC
C. Onset time
111. Indicate the part of a plasma level-time curve
A. tmax D. MTC
B. Cmax E. MEC
C. Onset time
112. Difference between the onset time and the time for the drug to decline back to the MEC.
A. Duration of action D. Cmax
B. Onset time E. MTC
C. AUC

113. Corresponds to the time required for the drug to reach the MEC
A. Duration of action D. Cmax
B. Onset time E. MTC
C. AUC
114. The plasma level time curve below portrays a drug that is administered in what route of administration?
A. IV bolus D. Intramuscular
B. Oral E. None of these
C. IV infusion
115. Presence of drug in this sample may reflect drug that has not been absorbed after an oral dose or may relfect drug
that has been expelled by biliary secretion after systemic absorption.
A. Feces D. Milk
B. Urine E. Sweat
C. Saliva
116. Which of the following are functions of pharmacokinetic models?
I. Predict plasma, tissue, and urine drug levels with any dosage regimen
II. Calculate the optimum dosage regimen for each patient individually
III. Evaluate differences in the rate or extent of availability between formulations
A. I only D. All of these
B. I and II E. None of these
C. II and III
117. Unit for zero order rate constant:
A. Concentration/time D. Concentration x time
B. Drug/volume E. 1/time
C. Volume/time

118. Unit for clearance:

A. Concentration/time D. Concentration x time
B. Drug/volume E. 1/time
C. Volume/time
119. Unit for plasma drug concentration
A. Concentration/time D. Concentration x time
B. Drug/volume E. 1/time
C. Volume/time
120. Unit for area under the curve
A. Concentration/time D. Concentration x time
B. Drug/volume E. 1/time
C. Volume/time
121. Unit for 1st order rate constant:
A. Concentration/time D. Concentration x time
B. Drug/volume E. 1/time
C. Volume/time
122. All of the following are included in the peripheral compartment/tissue compartment, EXCEPT:
I. Fat
II. Muscle
III. Cerebrospinal fluid
IV. Plasma
A. I and II D. IV only
B. II only E. None of these
C. III and IV

123. The curve that represents the initial, more rapid decline of drug from the central compartment into the tissue
compartment as seen in the plasma level time curve below is:
A. Absorption phase D. Metabolism phase
B. Distribution phase E. Elimination phase
C. Excretion phase
124. The pharmacokinetics of a drug given by constant IV infusion follows what input process?
A. Zero order D. A or B
B. 1st order E. None of these
C. 2nd order
125. Constant IV drug infusion are considered to have zero order drug absorption because of the direct input. Once the
drug is infused, most of the drug is eliminated by first order elimination.
A. Only the 1st statement is correct D. Both statement is correct
B. Only the 2nd statement is correct E. Cannot determine the validity
C. Both statement is incorrect
126. Drug elimination is usually divided into two major components: excretion and biotransformation. Drug excretion is the
removal of the interact drug.
A. Only the 1st statement is correct D. Both statement is correct
B. Only the 2nd statement is correct E. Cannot determine the validity
C. Both statement is incorrect
127. Nonvolatile and polar drugs are excreted mainly by renal excretion. Volatile drugs, such as gaseous anesthetics,
alcohol or drugs with hig volatility, are excreted via the lungs into expired air.
A. Only the 1st statement is correct D. Both statement is correct
B. Only the 2nd statement is correct E. Cannot determine the validity
C. Both statement is incorrect
128. Biotransformation is the process by which the drug is chemically converted in the body to a metabolite. Other name
for drug biotransformation is drug elimination.
A. Only the 1st statement is correct D. Both statement is correct
B. Only the 2nd statement is correct E. Cannot determine the validity
C. Both statement is incorrect
129. The two major drug eliminating organs in the body:
I. Heart
II. Lungs
III. Liver
IV. Kidney
A. I and II D. I and IV
B. II and III E. I and III
C. III and IV
130. Major route of elimination for many drugs:
A. Renal excretion D. B and C
B. Biliary excretion E. None of these
C. Fecal excretion
131. The processes by which a drug is excreted via the kidneys may include any combination of the following listed below,
EXCEPT:
I. Glomerular filtration
II. Active tubular secretion
III. Passive secretion
IV. Tubular reabsorption
A. I only D. II and III
B. I and II E. III only
C. II only
132. Unidirectional drug excretion process that occurs for most small molecules (MW < 500), including nonionized and
ionized drugs.
A. Glomerular filtration D. Enterohepatic recycling
B. Active tubular secretion E. None of these
C. Tubular reabsorption
133. A carrier mediated system that requires energy input, because the drug is transported against a concentration
gradient.
A. Glomerular filtration D. Enterohepatic recycling
B. Active tubular secretion E. None of these
C. Tubular reabsorption
134. Occurs after the drug is filtered through the glomerulus and can be an active or passive involving transporting back of
the drug into the plasma:
A. Glomerular filtration D. Enterohepatic recycling
B. Active tubular secretion E. None of these
C. Tubular reabsorption
135. All of the following listed below are characteristics of active tubular secretion process, EXCEPT:
I. Carrier mediated system that requires energy input
II. Drugs with similar structures may compete for the same carrier system
III. It can be a passive process
A. I only D. III only
B. I and II E. None of these
C. II and III
136. Active tubular secretion happens in this part of kidney:
A. Glomerulus D. Collecting Duct
B. Proximal tubule E. None of these
C. Distal tubule
137. Tubular reabsorption happens in this part of kidney:
A. Glomerulus D. Collecting Duct
B. Proximal tubule E. None of these
C. Distal tubule
138. Which renal elimination processes are influenced by protein binding?
A. Glomerular filtration D. Enterohepatic recycling
B. Active tubular secretion E. None of these
C. Tubular reabsorption
139. Which renal elimination processes are influenced by urinary pH?
A. Glomerular filtration D. Enterohepatic recycling
B. Active tubular secretion E. None of these
C. Tubular reabsorption
140. Which renal elimination processes are influenced by competitive inhibitors?
A. Glomerular filtration D. Enterohepatic recycling
B. Active tubular secretion E. None of these
C. Tubular reabsorption
141. For nos. 141-145
JPT is a 35-year-old male weighing 80 kg. The patient is to be given multiple IV bolus injections of an antibiotic
every 6hours. This effective concentration of this drug is 16 mcg/mL. After the patient is given a single IV dose, the
elimination half-life for the drug is determined to be 3.0 hr and the apparent VD is 196 mL/kg.
Determine a multiple IV dose regimen for this drug.
A. 255 mg every 6 hours D. 348 mg every 6 hours
B. 360 mg every 6 hours E. 445 mg every 6 hours
C. 362 mg every 6 hours
142. Assume that the antiboitic is 90% bioavailable and that the physician would like to continue oral medication every 6
hours. Determine the multiple oral dose regimen:
A. 386 mg every 6 hours C. 198 mg every 6 hours E. 401 mg every 6 hours
B. 252 mg every 6 hours D. 333 mg every 6 hours
144. What is the new drug plasma concentration if the patient takes a 500-mg dose every 6 hours?
A. 20.71 mcg/mL D. 21.12 mcg/mL
B. 19.2 mcg/mL E. 15.98 mcg/mL
C. 18.19 mcg/mL
145. What is the drug plasma concentration if a patient follows a dosage regimen of 500 mg tablet every 8 hiurs?
A. 16.12 mcg/mL D. 15.53 mcg/mL
B. 14.4 mcg/mL E. 18.11 mcg/mL
C. 25.39 mcg/mL
146. The purpose of giving a loading dose is to achieve desired plasma concentrations as quickly as possible. For a drug
with long elimination half-life, it may take a long time to achieve steady state levels.
A. Only the 1st statement is correct D. Both statement is correct
B. Only the 2nd statement is correct E. Cannot determine the validity
C. Both statement is incorrect
147. When several doses are administered for a drug with linear kinetics, drug accumulation may occur according to the
principle of superposition. The principle of superposition is used to examine the effect of an early, late, or missing dose on
steady state drug concentration.
A. Only the 1st statement is correct D. Both statement is correct
B. Only the 2nd statement is correct E. Cannot determine the validity
C. Both statement is incorrect
148. The physician wants the patient to take medication every 6 hours. What dose of theophylline would you recommend
(assume theophylline is 100% bioavailable)?
A. 289 mg D. 256 mg
B. 343 mg E. 450 mg
C. 315 mg

149. If you were to find that theophylline is available in 225mg capsules only, what dosage regimen would you
recommend?
A. 225 mg every 3 hours D. 225 mg every 6 hours
B. 225 mg every 4 hours E. 225 mg every 7 hours
C. 225 mg every 5 hours
150. Example of a drugs that undergo nonlinear pharmacokinetics thru saturable plasma protein binding:
I. Phenylbutazone
II. Warfarin
III. Levodopa
IV. Riboflavin
A. I only
B. I and II
C. II and III
D. III and IV
E. IV only
151. Example of a drugs that undergo nonlinear pharmacokinetics thru saturable transport in GUT wall:
I. Phenylbutazone
II. Warfarin
III. Levodopa
IV. Riboflavin
A. I only
B. I and II
C. II and III
D. III and IV
E. IV only
152. Drugs that demonstrate saturation kinetics usually shiw which of the following characteristics?
I. Elimination of drug does not follow simple first order kinetics
II. Elimination kinetics are linear
III. The area under the curve is not proportional to tge amount
IV. The elimination of half-life does not change as dose is increased.
A. I only D. II and III
B. I and III E. I and IV
C. II and III
153. Refers to a noncyclical change in the drug absorption or drug eliminationrate process over a period of time.
A. Chronopharmacokinetics D. Linear pharmacokinetics
B. Time-dependent pharmacokinetics E. A or B
C. Product inhibition
154. For a 70 kg male patient, the approximate volume of extracellular water is:
A. 27 L D. 5 L
B. 15 L E. 1 L
C. 12 L
155. For a 70 kg male patient, the approximate volume of intracellular water is:
A. 27 L D. 5 L
B. 15 L E. 1 L
C. 12 L
156. Represents the pressure gradient between the arterial end of the capillaries entering the tissue and the venous
capillaries leaving the tissue.
A. Osmotic pressure D. Arterial pressure
B. Concentration gradient E. Venous pressure
C. Hydrostatic pressure
157. Which of the following human tissues receives the highest blood flow?
A. Kidney D. Fat
B. Heart E. Muscle
C. Brain
158. Which of the following human tissues receives the least blood flow?
A. Kidney D. Fat
B. Heart E. Muscle
C. Brain
159. Physical property thay measures the ratio of the solubitity of the drug in the oil phase to solubility in aqueous phase
A. Osmotuc gradient D. Absorption coefficient
B. Partition coefficient E. Diffusion coefficient
C. Solubility gradient
160. The volume of blood that perfuses the liver which is cleared of drug per unit of time
A. Cardiac output D. Renal clearance
B. Regional blood flow E. Body clearance
C. Hepatic clearance
161. The total body clearance for a drug is 15 mL/min/kg. Renal clearance accounts for 10 mL/min/kg. What is the hepatic
clearance for the drug?
A. 15 mL/min/kg D. 3 mL/min/kg
B. 10 mL/min/kg E. 1 mL/min/kg
C. 5 mL/min/kg
162. Acetaminophen is converted to a reactive metabolite which causes hepatic necrosis thru what biotransformation
reaction?
A. Demethylation D. Deamination
B. Acetylation E. Conjugation
C. Aromatic hydroxylation
163. Codeine is converted to morphine thru what biotransformation reaction?
A. Demethylation D. Deamination
B. Acetylation E. Conjugation
C. Aromatic hydroxylation
164. These drugs are inactive and must be biotransformed in the body to metabolites that have pharmacologic activity:
A. Enteric coated drugs D. Xenobiotics
B. Prodrugs E. Lead drug
C. Orphan drug

165. Which of the following is under phasa I biotransformation reaction?

 I. Aormatic hydroxylation
II. Deamination
III. Nitroreduction
IV. Glycine conjugation
V. Methylation
A. I, II, III D. III, V
B. I, II, IV E. IV, V
C. II, III, IV
166. Which of the following is under phasa II biotransformation reaction?
I. Aormatic hydroxylation
II. Deamination
III. Nitroreduction
IV. Glycine conjugation
V. Methylation
A. I, II, III C. II, III, IV E. IV, V
B. I, II, IV D. III, V
167. CYP450 enzyme responsible for metabolism of warfarin, phenytoin and losartan:
A. CYP2C9 D. CYP3A4
B. CYP2D6 E. CYP1A2
C. CYP2C19
168. Which of the following CYP450 enzyme is prone to genetic polymorphism?
I. CYP2C9
II. CYP2D6
III.CYP2C19
IV.CYP3A4
A. I only D. I, II, III
B. I, II E. IV only
C. II, III
169. The most highly polymorphic CYP with more than 70 allelic variants reported
A. CYP2C9 D. CYP3A4
B. CYP2D6 E. CYP1A2
C. CYP2C19
170. The most abundant CYP450 in the liver and metabolizes over 50% of the clinically used drugs:
A. CYP2C9 D. CYP3A4
B. CYP2D6 E. CYP1A2
C. CYP2C19
171. Responsible for the metabolism of about 5% of marketed drugs including fluvoxamine, clozapine, olanzapine and
theophylline:
A. CYP2C9 D. CYP3A4
B. CYP2D6 E. CYP1A2
C. CYP2C19
172. Polymorphisms of this phase 1 enzyme result in a loss of enzymatic activity leading to the accumulation of the
chemotherapeutic agent 5-flourouracil, which leads to significant toxicity including leukopenia, thrombocytopenia, and
stomatitis.
A. CYP450 D. Glutathione transferase
B. Plasma pseudocholinesterase E. N-acetyl transferase
C. Dihydropyrimidine
173. The metabolism of procainamide, hydralazine and isoniazid is dependent on this phase II enzyme:
A. Uridine Diphosphate D. N-acetyltransferase
B. Thiopurine S-methyltransferase E. CYP450 enzyme
C. Glutathione transferase
176. Genome wide analysis of the genetic determinants of drug effucacy and toxicity:
A. Pharmacogenomic test D. Pharmacogenetics
B. Pharmacogenomics E. Pharmacogenetic test
C. Polymorphism test

177. The systemic absorption of drug is dependent on the following factors, EXCEPT:
A. The physicochemical properties of drug D. Drug liberation from the dosage form
B. The nature of the drug product E. Distribution of drugs to target tissues/organ
C. The anatomy and physiology of the drug
absorption site
178. Which of the following is not an advantage of parenteral route of administration?
I. Drug is given for immediate effect
II. Plasma drug level more precisely controlled
III. Decrease chance for adverse drug reaction
IV. Prevents tissue damage at the site of injection
A. I and II C. III and IV E. IV only
B. II and III D. I and III
179. Which of the following is not an advantage of enteral route of administration?
I. No 1st pass effectfor buccal or sublingual route
II. Safest and easiest route of administration
III. Rectal route is useful for patient who cannot swallow
IV. Complete drug absorption
A. I and II D. I and III
B. II and III E. IV only
C. III and IV
180. This age group is the most medicated group of patients and receive the highest proportion of medications:
A. 15-24 yrs D. 45-65
B. 25-35 yrs E. >/= 65 yrs
C. 35-45 yrs
181. All of the following is/are drug absorption characteristics for older adults, EXCEPT:
I. Increased gastric pH
II. Delayed gastric emptying
III. Decreased absorption surface
IV. Increased gastrointestinal motility
A. I only
B. I and II
C. II and III
D. III and IV
E. IV only
182. Which of the following is/are true regarding transdermal drug absorption?
I. Not advisable for older patients
II. There is significant difference in absorption of drugs between young and old individuals
III. Applicable for highly lipophilic chemicals
IV. Fentanyl is an example of drug administered thru transdermal route
A. I only
B. I and II
C. II and III
D. III and IV
E. IV only
183. Which of the following are/is true regarding subcutaneous drug absorption?
I. Drug absorption is through the vascular capillaries and lymphatic channels
II. Molecular size of the drug primarily determines the passage across the capillary endothelium
III. Subcutaneous absorption of drugs is not affected by aging
IV. Most common route of administration for therapeutic peptides a d proteins
A. I only
B. I, II and III
C. I, II and IV
D. II, III, na d IV
E. IV only

184. All of the following are true regarding pulmonary drug absorption characteristic, EXCEPT:
A. Age is an important parameter that affects the pharmacokinetics of inhaled drugs
B. Lung anatomy and physiology change with age which can effect pulmonary drug absorption
C. Young adults show a decrease of the alveolar surface a variation of lung elasticity and a decrease of the alveolar
capillary volume
D. There has been very little research for the pharmacokinetic and pharmacodynamics characteristics of new inhaled
drugs in older patients
E. Decrements in cognition praxis and executive function that are highly prevalent in frail older individuals have a
profoundly detrimental effect on inhaler technique

185. Which of the following are the two major factors of aging on drug distribution?
A. Route of administration and GI motility
B. 1st pass metabolism and drug clearance
C. Tissue fluidpH and urine pH
D. Gastric emptying and intestinal metabolism
E. Plasma protein concentration and body composition

186. Which of the following are the two major drug binding proteins in plasma?
A. Albumin and alpha1 acid glycoprotein
B. Nucleoprotein and albumin
C. Glycoprotein and lipoprotein
D. Enzymes and bile
E. Albumin amd lipoprotein

187. Combination of clarithromycin and warfarin may result to:

A. Decreased warfarin exposure and decreased anticoagulant effect
B. Decreased clarithromycin exposure and decreased antibacterial effect
C. Risk increased warfarin exposure and increased anticoagulant effect
D. Increased clarithromycin exposure and increased antibacterial effect
E. Increased toxicity of clarithromycin and warfarin

188. Which of the following is the most appropriate choice related to aging?
A. Increased extracellular fluid volume
B. Increased hepatic blood flow
C. Increased amount of sleep required
D. Increased subcutaneous fat as a percentage of total body mass
E. Increased size of alveolar ducts in the lung

189. Which of the following is the most appropriate choice to describe age associated changes that can affect
pharmacokinetics in older patients?
A. Changes in gastrointestinal function that lead to reduced drug absorption
B. Increase in total body water
C. Decrease in body fat
D. Decrease in serum albumin concentrations with advancing age
E. Decrease in creatinine clearance with advancing age

190. Which of the following statement regarding renal function and Pharmacokinetics in older patients is most accurate?
A. Decreased muscle mass is the reason for normal or low serum creatinine concentration in older patients even in the
presence of decreased renal function
B. Renal tubular secretion is not changed with aging
C. Serum creatinine concentration of 1.5mg/dL reflects normal renal function in older men
D. Glomerular function always declines with aging
E. Gentamicin an be used safely in older patients with serum creatinine concentrations of 1.7mg/dL

191. Which of the following statements concerning the safety of medications used by older patients is wrong?
A. Chlorpropamide can cause hypoglycemia
B. Benzodiazepines have large volume of distribution and are thus relatively safe for use in older people
C. Amantadine excretion depends on renal function and may cause confusion and falls if the dose is not adjusted for renal
impairment
D. Diphenhydramine may exacerbate urinary retention of older men
E. Meperidine is not an effective oral analgesic in dosages commonly used and may cause naurotoxicity

192. BMI (kg/m2) of an obese patient

A. <18.5
B. 18.5 – 24.9
C. 25 – 29.9
D. 30 - 39.9

193. BMI (kg/m2) of an individual with a normal body weight

A. <18.5
B. 18.5 – 24.9
C. 25 – 29.9
D. 30 - 39.9

194. All of the following statements are true regarding obesity, EXCEPT
A. Defined as body mass index (BMI) of 30 or higher and already has recognized as a “disease”
B. Obesity related chronic conditions includes diabetes, hypertension, high cholesterol, stroke, heart disease certain
cancers and arthritis
C. Obesity was associated with significantly increased mortality from cardiovascular diseases and obesity related cancers
D. Clinically a patient may be considered obese when the total body weight (TBW) is equal to or greater than 20% of ideal
body weight (IBW)
E. Individuals with obesity also have significantly higher health related quality of life scores than those individuals with
normal weights

195. Which of the following factors listed below influence drug distribution in the body?
I. 1st pass metabolism
II. Tissue perfusion
III. Tissue membrane permeability
IV. Physicochemical property of drug
A. I, II and III
B. II, III and IV
C. I, II and IV
D. I, III and IV
E. I and IV

196. All of the following are drug distribution characteristic for obese patient EXCEPT:
A. The obese individuals have an increased total tissue mass and adipose tissue mass thereby increasing volume of
distribution
B. Lipophilicity plays a major role in the drug distribution in obese individuals
C. In the obese patients, lipophilic medications show a high increased volume of distribution
D. The concentrations of plasma binding proteins, albumin, alpha 1 acid glycoprotein, and lipoprotein may be unchanged
(albumin) increased or decreased (alpha 1 acid glycoprotein) with obesity
E. Hydrophilic medications showed a high increased in volume of distribution in obese individuals

197. Which of the following ais true regarding pharmacokinetic characteristics of obese individuals?
I. For phase 1 metabolism CYP 3A4 activity was consistently higher in the obese group
II. Renal clearance is increased in the obese patients due to increased glomerular filtration and tubular secretion
III. Enzyme activities of CYP 2E1 and xanthine oxidase were consistently higher in the obese group
A. I only
B. I and II
C. II and III
D. I and III
E. III only
198 For nos. 198 – 199
Anjellie, a 45 year old female was admitted to the hospital with chief complaints of shortness of breath, wheezing, chills,
and fever. Past medical history included hypertension arthritis and asthma. The patients weight and height were 300lb
and 5’4 respectively:
Which of the following is correct for this patients body mass index (BMI)?
A. 35
B. 39.3
C. 60.9
D. 54.2
E. 51.6

199. If this patient has a serum creatinine of 1.0mg/dL calculate her estimated creatinine clearance in mL/min using
adjusted body weight in the Cockcroft gault equation
A. 115.3
B. 98
C. 61.3
D. 152.9
E. 120

200. Which of the following CYP450 isoenzymes showed a reduced activity in the obese patients?
A. CYP3A4
B. CYP2E1
C. CYP2C9
D. CYP2D6
E. Xanthine oxidase

201. Which of the following statements most accurately reflects the physiological changes commonly occurred with
obesity?
A. Glomerular filtration is usually increased in the obese patients
B. Tubular reabsorption is usually increased in the obese patients
C. Tubular secretion is usually decreased in the obese patients
D. The activity of uridine diphosphate glucoronosyltranferase is usually decreased in the obese patients
E. The size of the kidney is usually smaller in the obese patients

202. Which of the following statements most accurately reflects an appropriate drug dosing strategy for the obese
patients?
A. The TBW should always be used to calculate the Loading dose for the obese patients
B. The IBW should always be used to calculate the loading dose for the obese patients
C. The TBW should always be used to calculate the maintenance dose for the obese patients
D. The IBW should always be used to calculate the maintenance dose for the obese patients
E. Applying the pharmacokinetic principles and using modified weight strategies combining with therapeutic drug
monitoring

203. Which of the following are range is classified as infant?

A. Born at gestational age <38 weeks
B. 0-4 weeks postnatal age
C. 1 month to 2 years of age (1 month to <12 months old)
D. 2-12 years of age (1-12 years old)
E. 12-21 years of age (13-16, 18 or 19 years old)

204. Which of the following age range is classified as child?

A. Born at gestational age <38 weeks
B. 0-4 weeks postnatal age
C. 1 month to 2 years of age (1 month to <12 months old)
D. 2-12 years of age (1-12 years old)
E. 12-21 years of age (13-16, 18 or 19 years old)
205. Calculation of chid dose using Young’s rule is based on
A. Age
B. Weight
C. BSA
D. BMI
E. Dosage

206. Calculation of child dose using Clark’s rule is based on

A. Age
B. Weight
C. BSA
D. BMI
E. Dosage

207. All of the following are drug absorption characteristic of pediatric patients EXCEPT
A. In neonates, the Gastric pH is >4 and gastric emptying and intestinal transit are faster
B. In infants, the pH is 2-4 with increasing emptying and transit time but biliary function is near the adult pattern
C. Low gastric pH in neonates and infants result in higher Bioavailability (F) of acid labile drugs such as penicillin G,
ampicillin, and nafcillin
D. The fast GI transit reduces the rate and extent of absorption in neonates, infants and young children
E. The neonates are difficult to absorb fat soluble vitamins compared to infants and children due to the immature biliary
function

208. All of the following are drug distribution characteristic of pediatric patients EXCEPT
A. Changes in plasma protein concentration total body fat as well as total body water and extracellular water are the three
major factors exerting significant effects on drug distribution in pediatric population
B. The total body water is low in pediatric patients resulting to increase volume of distribution of hydrophilic drugs
C. The protein concentration are low in the neonates and infants up to one year old resulting to a high concentration of
unbound drug
D. In neonates and young infants phenytoin has a higher unbound fraction of the drug in circulation to exert activity
E. The age dependent Vd of lipophilic drugs is less apparent on pediatric population

209. Defined as those drugs where comparatively small differences in dose or concentration lead to dose and
concentration dependent, serious therapeutic failures and/or serious adverse drug reactions
A. Critical dose drugs
B. Narrow therapeutic index [NT] drugs
C. Prohibited and restricted drugs
D. A or B
E. A or C

210. Which of the following are functions of therapeutic drug monitoring services?
I. Design dosage regimen
II. Perform pharmacokinetic evaluation of drug concentrations
III. Monitor serum drug concentrations
IV. Compounding of intravenously administered drugs
A. I and II
B. II and III
C. I, II and III
D. II, III and IV
E. I, II and IV

211. The degree of reproducibility of the test results obtained by the analysis of the same samples by different analytical
laboratories or by different instruments
A. Precision
B. Sensitivity
C. Accuracy
D. Ruggedness
E. Specificity
212. The minimum detectable level or concentration of drug in serum that maybe approximated as the lowest drug
concentration that is two to three times the background noise:
A. Dynamic range
B. Sensitivity
C. Accuracy
D. Ruggedness
E. Linearity

213. Measurement of the variability or reproducibility of the data. Measurements are obtained by replication of various
drug concentrations and by replication of standard concentration curves prepared separately on different days
A. Precision
B. Sensitivity
C. Accuracy
D. Ruggedness
E. Specificity

214. Refers to the difference between the average assay values and the true or known drug concentrations
A. Precision
B. Sensitivity
C. Accuracy
D. Ruggedness
E. Specificity

215. Pharmaceutical product that delivers a recombinant gene to somatic cells in vivo
A. Monoclonal antibody
B. Gene therapy
C. Antisense drugs
D. RNAi
E. Biopharmaceuticals

216. Drugs that seek to block DNA transcription or RNA translation in order to moderate many disease processes
A. Monoclonal antibody
B. Gene therapy
C. Antisense drugs
D. RNAi
E. Biopharmaceuticals

217. Which of the following is not a requirement for effective oral drug delivery of protein and peptide drug?
A. Protection of the drug from degradation while in the harsh environment of the digestive tract
B. Consistent absorption of the drug in a manner that meets Bioavailability requirements
C. Consistent release of the drug so that it enters the bloodstream in a reproducible manner
D. Delivery of the drug through the GI tract or other organ and maintenance of pharmacologic effect similar to IV injection
E. None of these

218. What is the most frequent route of administration of biologic compounds?

A. Parenteral
B. Oral
C. Buccal
D. Sublingual
E. Rectal

219. A dosage form that allows at lead a two fold reduction in dosage frequency as compared to that drug presented as
an immediate release (conventional) dosage form:
A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets
220. Developed to disintegrate rapidly in the saliva after oral administration. The drug is dispersed in saliva and swallowed
with little or no water.
A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

221. Dosage form that releases drug at or near the intended physiologic site of action:
A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

222. Designed to release a drug at a predetermined rate for the constant drug concentration maintaining during a specific
period of time. The drug may release its medication properties over a controlled mode within a certain period where the
drug is released bit by bit in the body.
A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

223. Drug product designed to produce an instant effect where once administered the effects took place immediately and
its extended effect would be often happened at an hourly basis. When the drug concentration goes down, this drug
product may have the capability to maintain the effectiveness by the formulation itself
A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

224. Type of modified release drug product that is designed to release one dose of drug initially followed by a second or
more doses of drug at a later time
A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

225. All of the following are advantage of extended release drug product EXCEPT
I. Sustained therapeutic blood levels of the drug
II. Improved patient compliance
III. Reduction in adverse side effects and improvement in tolerability
IV. Dose dumping
V. Less possibility for high dose
A. I and II
B. II nad III
C. III and IV
D. IV and V
E. I and V

226. Defined either as the release of more than the intended fraction of drug or as the release of drug at a greater rate
than the customary amount of drug per dosage interval such that potentially adverse plasma levels may be reached
A. Drug accumulation
B. Dose dumping
C. Prolonged drug release
D. Over-extended release
E. A or B
227. Extended release tablets foe treatment of angina and hypertension
A. Acutrim
B. Minipress XL
C. Procardia XL
D. Adalat CR
E. Volmax

228. Extended release tablets for the relief of bronchospasm in patients with reversible obstructive airway disease
A. DynaCirc CR
B. Minipress XL
C. Procardia XL
D. Adalat CR
E. Volmax

229. Extended release tablets indicated as an adjunct to diet for the control of hyperglycemia in patients with non insulin
dependent diabetes
A. Glucotrol XL
B. Covera HS
C. Procardia XL
D. Adalat CR
E. Efidac 24

230. Systemic, scientific, risk based, holistic, and proactive approach to pharmaceutical development that begins with
predefined objectives and emphasizes the understanding of product and processes and process control
A. Quality by design (QbD)
B. Process analytical technology (PAT)
C. Process development
D. Design space
E. Risk based regulation

231. The geometrical region suitable for quality manufacturing when two/more process/material variables are plotted in a
two dimensional or higher dimensional space to show the combined effects of the relevant processing variables during
manufacturing.
A. Quality by design (QbD)
B. Process analytical technology (PAT)
C. Process development
D. Design space
E. BioRAM

232. Optimizes drug product development and performance by using therapy driven target drug delivery profiles as a
framework to achieve the desired therapeutic outcome.
A. Quality by design (QbD)
B. Process analytical technology (PAT)
C. Process development
D. Design space
E. BioRAM

233. A system for designing, analysing and controlling manufacturing through timely measurements (ie,during processing)
of critical quality and performance attributes of raw and in process materials and processes with the goal of ensuring final
product quality.
A. Quality by design (QbD)
B. Process analytical technology (PAT)
C. Process development
D. Design space
E. Risk based regulation
234. Therapeutic equivalence of a generic drug product with an innovator drug is assumed when the following conditions
are met.
I. They are approved as safe and effective
II. They are pharmaceutical equivalents and bioequivalents
III. They are adequately labelled
IV. They are manufactured in compliance with current good manufacturing practice regulations
V. They have the same time
A. I, II and III
B. II, III nad IV
C. III, IV and V
D. I, II, III and IV
E. I, II, III, IV and V

235. Pharmaceutical equivalent products may differ in which of the following aspects?
I. Active ingredients
II. Excipients
III. Impurities
IV. Release mechanism
V. Dosage form
A. I, II and III
B. II, III and IV
C. III, IV and V
D. I, II and V
E. II, IV and V

236. The most common way to estimate the ability of the liver to metabolize drug is to determine the Child-Pugh score for
a patient. All of the following are laboratory tests / clinical symptoms included in this test EXCEPT
A. Serum albumin
B. Total albumin
C. Prothrombin time
D kidney encephalopathy
E . Ascites

237. Which of the following is not true for patients with heart failure?
A. There is a decline of hepatic clearance for drugs with moderate – high hepatic extraction ratio
B. Increase Bioavailability of drugs
C. The volume of distribution for some drugs decreases in patients with heat failure
D. There is change in drug pharmacokinetic due to change in renal blood flow
E. Half-life of drug is difficult to predict in patients with renal failure

238. The fluid portion of a sample of whole blood allowed to clot for 30 minutes before centrifugation is
A. Serum
B. Plasma
C. Serous fluid
D. Citrate blood
E. Platelet

239. The fluid portion of whole blood centrifuged before clot formation is called
A. Serum
B. Plasma
C. Serous fluid
D. Citrate blood
E. Platelet

240. Which of the following drugs listed below has the least percentage of protein binding?
A. Ampicillin
B. Chloramphenicol
C. Lidocaine
D. Phenytoin
E. Vancomycin.

241. Which of the following drugs listed below has the highest percentage of protein binding?
A. Ampicillin
B. Chloramphenicol
C. Lidocaine
D. Phenytoin
E. Vancomycin

242. Which of the following statements best describes F?

A. Rate of absorption of the administered drug into the systemic circulation
B. Amount of administered drug that reaches the systemic circulation
C. Speed at which the administered drug reaches the systemic circulation
D. Fraction of the administered drug that reaches the systemic circulation
E. Amount of drug absorbed after drug dissolution

243. If 500mg of a drug is given orally and 250mg is absorbed into the systemic circulation, What is F?
A. 0.2
B. 0.3
C. 0.4
D. 0.5
E. 0.6

244. Antifungal drug used to treat systemic mycoses which is available in a liposomal formulation that is less nephrotoxic
and better tolerated than the conventional form
A. Heparin
B. Levodopa
C. Amphotericin
D. Nystatin
E. Griseofulvin

245. Which of the following drug is present in the extracellular fluid compartment of the body?
A. Phenytoin
B. Ethanol
C. Morphine
D. Gentamicin
E. Haloperidol

246. Which of the following drugs listed below Is a substrate of CYP2D6 isoenzyme?
A. Caffeine
B. Paclitaxel
C. Phenytoin
D. Alcohol
E. Codeine

247. Which of the following is not a prodrug?

A. Azathioprine
B. Prednisone
C. Zidovudine
D. Morphine
E. Enalapril

248. All of the following are true regarding drug elimination by the kidney EXCEPT
A. Most of drugs unless highly bound to plasma protein cross the glomerular filter freely
B. Many drugs especially weak acids and weak bases are reactively secreted into the renal tubule and thus more rapidly
excreted
C. Water soluble drugs are passively reabsorbed by diffusion across the tubule so are not efficiently excreted in the urine
D. Because of pH partition weak acids are more rapidly excreted in alkaline urine and vice versa
E. Several important drugs are removed predominantly by renal excretion and are liable to cause toxicity in elderly
persons and patients with renal disease

249. A requirement imposed by FDA for in vitro and/or in vivo testing of specified drug products which must be satisfied as
a condition of marketing
A. Bioavailability requirement
B. Bioequivalece requirement
C. Biowaiver
D. Regulatory requirement
E. Bioassay

250. Drug products that contain the identical therapeutic moiety or its precursor but not necessarily in the same amount or
dosage form or as the same salt or ester
A. Pharmaceutical equivalents
B. Bioequivalents
C. Pharmaceutical alternative
D. Therapeutic equivalence
E. Therapeutic alternative

251. Multisource drug product that has been approved by the FDA as a therapeutic equivalent to the reference listed drig
product (usually the brand or innovator drug product) and has proven equivalent drug product performance
A. Innovator drug product
B. Orphan drug
C. Experimental drug
D. Generic drug product
E. Pharmaceutical equivalent product

252. Defined as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and
becomes available at the site of action
A. Bioavailability
B. Bioequivalece
C. Drug absorption
D. Biowaiver
E. Drug liberation

253. Defined as the absence of a significant difference in the rate and extent to which the active ingredient or active
moiety becomes available at the site of drug action when administered at the same molar dose under similar conditions in
an appropriately designed study
A. Bioavailability
B. Bioequivalece
C. Relative Bioavailability
D. Biowaiver
E. Absolute Bioavailability

254. Compares the Bioavailability of the active drug in the systemic circulation following extra vascular administration with
the Bioavailability of the same drug following intravenous administration
A. Bioavailability
B. Bioequivalece
C. Relative Bioavailability
D. Biowaiver
E. Absolute Bioavailability

255. The systemic exposure of a drug in a designed formulation (generally reffered to as treatment A or reference
formulation) is compared with that of the same drug administered in a reference formulation (generally reffered to as
treatment B or reference formulation)
A. Bioavailability
B. Bioequivalence
C. Relative Bioavailability
D. Biowaiver
E. Absolute Bioavailability

256. The Bioavailability of a new investigational dryg was studied in 12 volunteers. Eacg volunteer received either a single
oral tablet containing 200 mg of the drug 5mL of a pure aqueous solution containing 200 mg of the drug or a single IV
bolus injection containing 50 mg of the drug. Plasma samples were obtained periodically up to 48 hours after the dose
and assayed for dru concentration. The average AUC values (0-48 hours) are given 8n the table below.
From these data calculate the relative Bioavailability of the drug from the tablet compared to the oral solution
A. 100%
B. 101%
C. 102%
D. 103%
E. 104%

257. The absolute drug Bioavailability from the tablet is calculated:

A. 35.9%
B. 45.5%
C. 59.2%
D. 61.9%
E. 70.1%

258. Which of the following is not a drug absorption rate limiting step for solid oral immediate release drug products?
A. Disintegration of the drug product
B. Subsequent release of the drug
C. Dissolution of the drug in an aqueous environment
D. Absorption across cell membranes into the systemic circulation
E. Drug protein binding

259. Which of the following is the slowest step and therefore exerts a rate limiting effect on drugs that have a very poor
aqueous solubility?
A. Disintegration of the drug product
B. Subsequent release of the drug
C. Dissolution of the drug in an aqueous environment
D. Absorption across cell membranes into the systemic circulation
E. Drug protein binding

260. For orally administered drug that has a high aqueous solubility whichis the rate limiting step for drug absorption?
A. Disintegration of the drug product
B. Subsequent release of the drug
C. Dissolution of the drug in an aqueous environment
D. Absorption across cell membranes into the systemic circulation
E. Drug protein binding

261. Solid drug products exempted from disintegration tests includes which of the following?
I. Troches
II. Tablets that are intended to be chewed
III. Drug products intended for sustained release
IV. Sugar coated tablet
A. I and II
B. II and III
C. III and IV
D. I, II, and III
E. II, III and IV
262. Defined by the USP NF (National Formulary) as "that statein which any residues of the tablet except fragments of
insoluble coating, remaining on the screen of the test apparatus in the soft mass have no palpably firm core"
A. Complete dissolution
B. Complete absorption
C. Complete drug liberation
D. Complete disintegration
E. A or B

263. The process by which a solid drug substance becomes dissolved in a solvent over time:
A. Dissolution
B. Disintegration
C. Absorption
D. Liberation
E. Solubilization

264. The Physicochemical property gives some indication of the relative affinity of the drug for oil and water. A drug that
has high affinity for oil may have poor release and dissolution from the drug product
A. Hygroscopicity
B. Polymorphism
C. pKa and pH
D. Particle size
E. Partition coefficient

265. Which of the following is true regarding solubility pH profile of a drug?

I. An acidic drug is more soluble in an acidic medium forming a soluble salt
II. A basic drug is more solublein the intestine forming a soluble salt
III. The solubility pH profilegives a rough estimation of the completeness of dissolution for a dose of a drug in the stomach
or in the small intestine
A. I only
B. I and II
C. II and III
D. I and III
E. III only

266. Which of the following is trie regarding particle size and drug absorption
I. Dissolution rate is proportional to the surface area of the drug
II. The effective surface area of a drug is decreased enomously by a reduction in the particle size
III. Reduction of particle size increases the absorption of the drug
A. I only
B. I and II
C. II and III
D. I and III
E. III only

267. Which of the following drug Excipients increases the absorption rate constant of a drug?
A. Lubricants
B. Disintegrants
C. Enteric coating
D. Sustained release agents
E. Coating agent

268. USP NF dissolution apparatus for extended release drug products

A. Apparatus 1
B. Apparatus 2
C. Apparatus 3
D. Apparatus 4
E. Apparatus 5
269. USP NF dissolution apparatus for drug products containing low water soluble drugs
A. Rotating basket
B. Paddle
C. Reciprocating cylinder
D. Flow cell
E. Paddle over disk

270. Which of the following dissolution apparatus is/are used for transdermal drug products?
I. Paddle over disk
II. Cylinder
III. Diffusion cell
IV. Reciprocating
V. Reciprocating disk
A. I and II
B. II and III
C. I, II and III
D. II, III, and IV
E. V only
271. Static diffusion system that issued for characterizing drug permeation through a skin model. They are commonly
available to characterize in vitro drug release and drug permeation kinetics from topically applied dosage form (eg.
Ointment, Cream) or transdermal drug product
A. Paddle over disk
B. Reciprocating disk
C. Intrinsic dissolution method
D. Rotating bottle method
E. Franz diffusion cell

272. A scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability
A. Biopharmaceutics classification system (BCS)
B. Pharmacokinetics classification system (PCS)
C. Absorption classification system (ACS)
D. Permeation classification system (PCS)
E. Solubility classification system (SCS)

273. Biopharmaceutics classification system (BCS) class for drug substances with high solubility and low permeability
A. Class 1
B. Class 2
C. Class 3
D. Class 4
E. Class 5

274. Biopharmaceutics classification system (BCS) class for drug substances with low solubility and low permeability
A. Class 1
B. Class 2
C. Class 3
D. Class 4
E. Class 5

275. All of the following are true regarding colonic drug delivery EXCEPT
A. Drugs that are destroyed following oral administration by the acidic environment of the stomach or metabolized by
enzymes may only be slightly affected in the colon
B. Crohn's disease may be more effectively treated by direct drug delivery to the colon
C. Drig delivery to the colon is highly influenced by several factors including high bacterial level
D. Drugs such as metoprolol, NSAIDs, steroids, peptides, and vaccines are well absorbed in the colon
E. Not recommended for the delivery of proteins and therapeutic peptides
276. Which of the following is true for rectal route of administration?
A. Many drugs are poorly or erratically absorbed across the rectal mucosa
B. Release of drug from a suppository does not depend on the composition of the suppository base
C. Not applicable for systemic delivery
D. Slow absorption of low molecular weight drugs
E. Prone to 1st pass metabolism

277. This component of a transdermal patch is important for maintaining uninterrupted skin contact for drug diffusion
through the skin
A. Backing or support layer
B. Drug layer
C. Release controlling layer
D. Pressure sensitive adhesive
E. Protective strip

278. Ethyl vinyl copolymer is a component of which of the following part of transdermal patch?
A. Backing or support layer
B. Drug layer
C. Release controlling layer
D. Pressure sensitive adhesive
E. Protective strip

279. These Excipients are incorporated into the drug product to promote system drug absorption fron the application site.
A. Absorption enhancers
B. Permeation enhancers
C. Systemic enhancers
D. A or B
E. A or C

280. Part of the skin that is the major barrier to systemic drug absorption of transdermal products
A. Stratum granulosum
B. Stratum corneum
C. Stratum lucidum
D. Stratum spinosum
E. Stratum basale

281. Estraderm(brand name) , and estradiol transdermal contains ethanol which serves as which of the following?
A. Provide soothing effect to the skin
B. Promotes drug delivery to stratum corneum
C. Increases stability of the patch
D. Prevents microbial growth on the patch
E. Potentiate the effect ofthe patch

282. A technique using a small electric charge to deliver drug containing an ionic charge through the stratum corneum
A. Charge induction
B. Ionic charge delivery
C. Sonophoresis
D. Electrophoresis
E. Iontophoresis

283. This parenteral route of administration is often used for allergy and other diagnostic tests such as tuberculosis
A. Intradermal injection
B. Intra-arterial injection
C. Intrathecal injection
D. Subcutaneous injection
E. Intravenous infusion
284. Parenteral route of administration generally used for insulin injection
A. Subcutaneous injection
B. Intravenous injection
C. Intramuscular injection
D. Intravenous infusion
E. Intradermal injection

285. Which of the following is the safest and easiest route of drug administration?
A. Intravenous
B. Rectal (PR)
C. Oral (PO)
D. Inhalational
E. Intranasal

286. In drug absorption some polar molecules may not be able to traverse the cell membrane but instead go through gaps
or tight junctions between cells this process is known as
A. Transcellular absorption
B. Lipid diffusion
C. Facilitated diffusion
D. Paracellular drug diffusion
E. Active transport

287. Cell membrane structure theory that states that the plasma membrane is composed of two layers of phospholipid
between two surface layers of proteins with the hydrophilic "head" grouos of the phospholipids facing the protein layers
and the hydrophobic "tail" groups of the phospholipids aligned in the interior.
A. Unit membrane theory
B. Fluid mosaic theory
C. Drug absorption theory
D. Hydrophilic - lipophilic balance theory
E. Phospholipid theory

288. According to this, the cell membrane consists of globular proteins embedded in a dynamic fluid, lipid bilayer matrix.
These proteins provide a pathway for the selective transfer of certain polar molecules and charged ions through the lipid
barrier.
A. Unit membrane theory
B. Fluid mosaic theory
C. Drug absorption theory
D. Hydrophilic - lipophilic balance theory
E. Phospholipid theory

289. According to the pH partition hypothesis if the pH on one side of the cell membrane differs from the pH on the other
side of the membrane then:
A. The drug (weak acid or base) will ionize to different degrees on respective sides of the membranes
B. The total drug concentrations (ionized plus non ionized drug) on either side of the membrane will be equal
C. Compartment in which the drug is more highly ionized will contain the greater total drug concentration
D. A and B
E. A and C

290. A carrier mediated transport system differing from the active transport in the drug mibes along the concentration
gradient
A. Endocytosis
B. Passive diffusion
C. Pinocytosis
D. Facilitated diffusion
E. Connective transport
291. Defined as a series of structurally related chemical compounds that have shown interesting pharmacological activity
and from which drug candidates may be selected
A. Leads
B. Drug candidates
C. Drug substances
D. Active pharmaceutical ingredient
E. Drug product

292. Defined as pharmacologically active compounds undergoing evaluation of their potential as future drug substances
A. Leads
B. Drug candidates
C. Drug substances
D. Active pharmaceutical ingredient
E. Drug product

293. The most important class of hydrolysis reactions influencing the stability of pro-drug and drug candidates
A. Hydrolysis of esters
B. Hydrolysis of amides
C. Hydrolysis of carboxyl functional group
D. Hydrolysis of alcohols
E. Hydrolysis of imides

294. Which of the following hydrolysable carboxyl compound is present on acetyl salicylic acid (ASA)?
A. Imide
B. Amide
C. Alcohol
D. Ester
E. Lactam

295. Lipinski's rule of five is based on an analysis of key Physicochemical properties of drug substances in the world drug
index. The rule is based on four Physicochemical parameters that are globally associated with solubility and permeability
and it states that the drug substances are most likely to have good Bioavailability when the following four parameters
listed below are fullfilled EXCEPT
A. Number of hydrogen bond (H-bond)
B. Number of H bond acceptors <10
C. Molecular weight (MW) is <500
D. Logarithm of the calculated octano/water partition coefficient logP <5
E. Number of functional groups present <5

296. Carriers that have two or more substrates moving in one direction during the transport process are called
A. Antiports
B. Symports
C. Active transporters
D. Enzyme
E. Bioports

297. Cell culture which serves as an easy screen of drug permeation and for prediction of human intestinal permeability
and fraction of the oral dose absorbed in man
A. Caco-2 cells
B MDCK cell line
C. HepG2
D. MDCK-MDR1
E. HT-29
298. Which of the following is the pH of the stomach at fasting state?
A. 2.1 - 3.4
B. 4.2 - 5.1
C. 1.1 - 2.0
D. 4.1 - 5.2
E. 1.5 - 2.9

299. The most common dissolution theory. This theory assumes that the dissolution rateis transport rate controlled and in
fact most dissolution processes are controlled by this diffusion - convection - controlled step
A. Reaction rate theory
B. Film theory
C. Noyes whitney
D. Ficks theory
E. Transport rate theory

300. Cell lines used hepatic drug uptake and metabolism that have also been developed to serve as a tool for
biotransformation studies in conjunction with drug transport
A. Caco-2 cells
B MDCK cell line
C. HepG2
D. MDCK-MDR1
E. HT-29