Top 100 MCQs of Biopharmaceutics and Pharmacokinetics

Here we collect the 100 MCQs of Biopharmaceutics and Pharmacokinetics for Nepal Pharmacy Council License Exam, Pharmacy Loksewaand Various Pharmacy Entrance Exam.

1. Which of the following is used when bioavailability measurement by pharmacokinetic methods is difficult?
A) Therapeutic response
B) Acute pharmacologic response
C) In vitro dissolution test
D) Clinical trial
Correct Answer: B

2. What is constructed to determine bioavailability in the acute pharmacologic response method?
A) Dose-response graphs
B) Time-response graphs
C) Effect-time curves
D) All of the above
Correct Answer: D

3. What is a major drawback of using therapeutic response to measure bioavailability?
A) Costly and time-consuming
B) Inaccurate due to variability
C) Improper quantitation
D) Requires healthy subjects
Correct Answer: C

4. Which physicochemical property of most drugs greatly influences their absorption characteristics from the GIT?
A) Molecular weight
B) Lipid solubility
C) Dissolution rate
D) pH
Correct Answer: C

5. What is the preferred method for assessing the therapeutic efficacy of drugs with a slow dissolution rate?
A) In vitro disintegration test
B) In vivo determination of bioavailability
C) Clinical trials
D) In vitro dissolution testing
Correct Answer: B

6. What kind of conditions does a closed-compartment dissolution apparatus operate under?
A) Sink conditions
B) Non-sink conditions
C) Steady-state conditions
D) Variable conditions
Correct Answer: B

7. Which dissolution apparatus is used for very poorly aqueous soluble drugs?
A) Rotating basket apparatus
B) Closed-compartment apparatus
C) Open-compartment apparatus
D) Dialysis systems
Correct Answer: D

8. What kind of dissolution apparatus brings the dosage form in continuous contact with fresh, flowing dissolution medium?
A) Closed-compartment apparatus
B) Open-compartment apparatus
C) Dialysis systems
D) Rotating basket apparatus
Correct Answer: B

9. What factor is not considered in the design of a dissolution test?
A) Size of the container
B) Shape of the container
C) Age of the test subject
D) Speed of agitation
Correct Answer: C

10. What is the best in vitro method to ensure the biologic availability of a drug from its formulation?
A) In vitro disintegration test
B) In vivo bioavailability test
C) In vitro dissolution test
D) Clinical response test
Correct Answer: C

11. What does the area under the curve (AUC) represent in pharmacokinetics?
A) Drug absorption rate
B) Total drug exposure
C) Peak plasma concentration
D) Time to reach peak concentration
Correct Answer: B

12. Which parameter is used to describe the time required for the plasma concentration of a drug to reduce by half?
A) AUC
B) Cmax
C) Tmax
D) T1/2 (Half-life)
Correct Answer: D

13. What is the term for the fraction of an administered drug that reaches the systemic circulation in an unchanged form?
A) Bioequivalence
B) Bioavailability
C) Biotransformation
D) Bioaccumulation
Correct Answer: B

14. Which model is often used to describe drug elimination from the body?
A) Single-compartment model
B) Two-compartment model
C) Multi-compartment model
D) All of the above
Correct Answer: D

15. What does Cmax represent in a plasma concentration-time curve?
A) Time to reach maximum concentration
B) Maximum plasma concentration
C) Total drug exposure
D) Rate of absorption
Correct Answer: B

16. Which phase follows drug administration in the plasma concentration-time curve?
A) Absorption phase
B) Distribution phase
C) Elimination phase
D) Excretion phase
Correct Answer: A

17. What is the term for the process by which a drug is distributed throughout the body?
A) Absorption
B) Distribution
C) Metabolism
D) Excretion
Correct Answer: B

18. What is the primary organ responsible for drug metabolism?
A) Kidney
B) Liver
C) Lung
D) Intestine
Correct Answer: B

19. What is the first-pass effect?
A) The initial distribution of a drug
B) The metabolism of a drug before it reaches systemic circulation
C) The excretion of a drug through the kidneys
D) The absorption of a drug in the stomach
Correct Answer: B

20. Which of the following factors can affect drug bioavailability?
A) Drug formulation
B) Route of administration
C) Food intake
D) All of the above
Correct Answer: D

21. Which method is used to measure the solubility of a drug in various solvents?
A) Dissolution testing
B) Solubility testing
C) Bioavailability testing
D) Pharmacokinetic testing
Correct Answer: B

22. What does the term ‘sink conditions’ refer to in dissolution testing?
A) Conditions where drug concentration in solution is kept low
B) Conditions where drug concentration in solution is high
C) Conditions where no drug is dissolved
D) Conditions where the dissolution medium is replaced frequently
Correct Answer: A

23. Which of the following is NOT a factor related to the dissolution fluid in dissolution testing?
A) Composition
B) Viscosity
C) Temperature
D) Speed of agitation
Correct Answer: D

24. What type of dissolution apparatus is the rotating basket apparatus?
A) Open-compartment
B) Closed-compartment
C) Dialysis system
D) Fluid flow system
Correct Answer: B

25. What does the term ‘non-sink conditions’ refer to in dissolution testing?
A) Conditions where drug concentration in solution gradually increases
B) Conditions where drug concentration in solution is kept low
C) Conditions where the drug does not dissolve
D) Conditions where the dissolution medium is frequently replaced
Correct Answer: A

26. Which factor is considered when introducing the dosage form into the dissolution fluid?
A) Method of introduction
B) Speed of agitation
C) Temperature of the fluid
D) Volume of the container
Correct Answer: A

27. What type of container is used in the rotating basket apparatus?
A) Cylindrical glass vessel with hemispherical bottom
B) Flat-bottomed beaker
C) Conical flask
D) Rectangular tank
Correct Answer: A

28. In dissolution testing, what is the importance of maintaining the temperature of the dissolution fluid?
A) To ensure drug stability
B) To mimic physiological conditions
C) To control drug release rate
D) To prevent drug degradation
Correct Answer: B

29. What is the primary goal of in vitro dissolution testing?
A) To replace in vivo bioavailability tests
B) To assess the pharmacokinetic profile of a drug
C) To determine the therapeutic index of a drug
D) To evaluate the safety of a drug
Correct Answer: A

30. Which condition in dissolution testing aims to keep the drug concentration constant at a low level?
A) Sink conditions
B) Non-sink conditions
C) Steady-state conditions
D) Equilibrium conditions
Correct Answer: A

31. Which technique involves reducing the particle size to enhance drug solubility?
A) Micronization
B) Complexation
C) Solvent evaporation
D) pH adjustment
Correct Answer: A

32. What is the role of surfactants in enhancing drug solubility?
A) To increase particle size
B) To decrease dissolution rate
C) To reduce surface tension
D) To increase viscosity
Correct Answer: C

33. Which method involves the use of a solid dispersion to improve drug solubility?
A) Micronization
B) Complexation
C) Co-precipitation
D) Lyophilization
Correct Answer: C

34. What is the primary purpose of using cyclodextrins in drug formulations?
A) To increase molecular weight
B) To enhance drug solubility
C) To decrease drug stability
D) To slow drug release
Correct Answer: B

35. What is the effect of increasing the pH of the dissolution medium on the solubility of a weakly acidic drug?
A) Decreases solubility
B) Increases solubility
C) No effect
D) Precipitates the drug
Correct Answer: B

36. Which solubility enhancement technique involves the use of a solvent and anti-solvent?
A) Micronization
B) Solvent evaporation
C) pH adjustment
D) Co-precipitation
Correct Answer: D

37. How do complexing agents enhance drug solubility?
A) By forming insoluble complexes
B) By forming soluble complexes
C) By increasing particle size
D) By reducing surface area
Correct Answer: B

38. Which method is used to enhance solubility by altering the crystalline form of the drug?
A) Micronization
B) Co-crystallization
C) Solvent evaporation
D) Surfactant addition
Correct Answer: B

39. What is the main advantage of using solid dispersions for drug solubility enhancement?
A) Increased particle size
B) Improved dissolution rate
C) Reduced drug stability
D) Slower drug release
Correct Answer: B

40. Which technique uses high-energy processes to enhance drug solubility?
A) Micronization
B) Complexation
C) Co-precipitation
D) Lyophilization
Correct Answer: A

41. Which process is responsible for the movement of drugs from the site of administration into the blood?
A) Absorption
B) Distribution
C) Metabolism
D) Excretion
Correct Answer: A

42. What is the primary factor influencing drug absorption from the gastrointestinal tract?
A) Drug formulation
B) Blood flow to the absorption site
C) Gastric emptying time
D) All of the above
Correct Answer: D

43. Which route of administration bypasses the first-pass effect?
A) Oral
B) Intravenous
C) Subcutaneous
D) Rectal
Correct Answer: B

44. What does the term ‘bioavailability’ refer to in pharmacokinetics?
A) The rate and extent of drug absorption
B) The distribution of a drug in the body
C) The metabolism of a drug
D) The excretion of a drug
Correct Answer: A

45. Which form of a drug is more readily absorbed in the gastrointestinal tract?
A) Ionized form
B) Non-ionized form
C) Solid form
D) Complexed form
Correct Answer: B

46. What factor can enhance the absorption of lipid-soluble drugs?
A) Increased gastric motility
B) High-fat meal
C) Low pH of the stomach
D) Increased bile secretion
Correct Answer: B

47. Which route of administration is affected by the hepatic first-pass metabolism?
A) Intramuscular
B) Intravenous
C) Oral
D) Sublingual
Correct Answer: C

48. What is the effect of food on the absorption of a drug administered orally?
A) Always increases absorption
B) Always decreases absorption
C) Can either increase or decrease absorption
D) Has no effect on absorption
Correct Answer: C

49. Which factor does not influence the absorption of drugs from the gastrointestinal tract?
A) Surface area of the absorption site
B) Blood flow to the absorption site
C) Lipid solubility of the drug
D) Color of the drug
Correct Answer: D

50. Which type of drug formulation can bypass the gastrointestinal tract and enter directly into the bloodstream?
A) Tablet
B) Capsule
C) Transdermal patch
D) Oral solution
Correct Answer: C

51. What is the term for the reversible transfer of a drug from one location to another within the body?
A) Absorption
B) Distribution
C) Metabolism
D) Excretion
Correct Answer: B

52. Which tissue has the highest blood flow and thus receives a higher amount of drug during distribution?
A) Adipose tissue
B) Muscle tissue
C) Brain tissue
D) Liver tissue
Correct Answer: D

53. What is the role of plasma proteins in drug distribution?
A) Increase drug absorption
B) Enhance drug metabolism
C) Bind drugs and affect their distribution
D) Increase drug excretion
Correct Answer: C

54. Which factor does not influence the distribution of a drug in the body?
A) Blood flow to tissues
B) Drug solubility
C) Plasma protein binding
D) Gastric emptying time
Correct Answer: D

55. What is the volume of distribution (Vd) in pharmacokinetics?
A) The volume of blood in the body
B) The volume of plasma in the body
C) A hypothetical volume representing drug distribution
D) The volume of the administered drug
Correct Answer: C

56. Which compartment does a drug first enter after intravenous administration?
A) Interstitial fluid
B) Intracellular fluid
C) Plasma
D) Fat tissue
Correct Answer: C

57. What does a high volume of distribution indicate about a drug?
A) High plasma concentration
B) Extensive distribution in tissues
C) Low tissue binding
D) Rapid excretion
Correct Answer: B

58. Which factor is most likely to limit the distribution of a drug to the brain?
A) Blood-brain barrier
B) Plasma protein binding
C) Drug solubility
D) Blood flow rate
Correct Answer: A

59. What is the effect of drug-protein binding on the drug’s duration of action?
A) Shortens the duration
B) Prolongs the duration
C) No effect
D) Increases the dose required
Correct Answer: B

60. Which of the following is a characteristic of a drug with a low volume of distribution?
A) High tissue binding
B) High plasma concentration
C) High lipid solubility
D) Extensive tissue distribution
Correct Answer: B

61. What is the primary site for drug metabolism in the body?
A) Kidneys
B) Liver
C) Lungs
D) Intestines
Correct Answer: B

62. Which phase of drug metabolism involves conjugation reactions?
A) Phase I
B) Phase II
C) Phase III
D) Phase IV
Correct Answer: B

63. What is the role of cytochrome P450 enzymes in drug metabolism?
A) Absorption of drugs
B) Distribution of drugs
C) Oxidation of drugs
D) Excretion of drugs
Correct Answer: C

64. Which of the following is a phase I metabolic reaction?
A) Glucuronidation
B) Sulfation
C) Oxidation
D) Acetylation
Correct Answer: C

65. What is the effect of enzyme induction on drug metabolism?
A) Decreased drug metabolism
B) Increased drug metabolism
C) No effect on drug metabolism
D) Prolonged drug action
Correct Answer: B

66. Which factor can affect the rate of drug metabolism?
A) Age
B) Genetic factors
C) Liver function
D) All of the above
Correct Answer: D

67. Which type of drug interaction involves one drug affecting the metabolism of another drug?
A) Pharmacodynamic interaction
B) Pharmacokinetic interaction
C) Chemical interaction
D) Physical interaction
Correct Answer: B

68. What is a prodrug?
A) An inactive drug that requires metabolism to become active
B) A drug that is active in its original form
C) A drug that is eliminated unchanged
D) A drug that does not undergo metabolism
Correct Answer: A

69. What is the role of phase II metabolism in drug elimination?
A) Increasing drug solubility
B) Decreasing drug solubility
C) Increasing drug absorption
D) Decreasing drug absorption
Correct Answer: A

70. Which phase of metabolism is primarily responsible for making drugs more water-soluble for excretion?
A) Phase I
B) Phase II
C) Phase III
D) Phase IV
Correct Answer: B

71. What is the primary route of drug excretion from the body?
A) Biliary excretion
B) Renal excretion
C) Pulmonary excretion
D) Sweat excretion
Correct Answer: B

72. Which organ is primarily responsible for the renal excretion of drugs?
A) Liver
B) Kidney
C) Lung
D) Intestine
Correct Answer: B

73. Which process in the kidneys involves the passive diffusion of drugs from the blood into the renal tubules?
A) Glomerular filtration
B) Tubular secretion
C) Tubular reabsorption
D) Active transport
Correct Answer: A

74. What is the effect of urine pH on the excretion of weakly acidic drugs?
A) Increased excretion in acidic urine
B) Increased excretion in alkaline urine
C) No effect on excretion
D) Decreased excretion in alkaline urine
Correct Answer: B

75. Which factor does not affect the renal excretion of drugs?
A) Blood flow to the kidneys
B) Urine pH
C) Plasma protein binding
D) Gastric emptying time
Correct Answer: D

76. What is biliary excretion?
A) Excretion of drugs through the bile
B) Excretion of drugs through the kidneys
C) Excretion of drugs through the lungs
D) Excretion of drugs through the sweat
Correct Answer: A

77. Which type of drugs are primarily excreted unchanged in the urine?
A) Lipid-soluble drugs
B) Water-soluble drugs
C) Highly protein-bound drugs
D) Metabolized drugs
Correct Answer: B

78. What is enterohepatic recycling?
A) The recycling of drugs between the liver and intestines
B) The reabsorption of drugs in the kidneys
C) The distribution of drugs in the blood
D) The excretion of drugs through the sweat
Correct Answer: A

79. Which factor can increase the half-life of a drug in the body?
A) Increased renal excretion
B) Decreased renal excretion
C) Increased hepatic metabolism
D) Decreased plasma protein binding
Correct Answer: B

80. What is the effect of active tubular secretion on drug excretion?
A) Decreases drug excretion
B) Increases drug excretion
C) No effect on drug excretion
D) Slows drug metabolism
Correct Answer: B

81. Which of the following factors affects the rate of drug absorption?
A) Drug solubility
B) Surface area of the absorption site
C) Blood flow to the absorption site
D) All of the above
Correct Answer: D

82. What is the primary objective of biopharmaceutics?
A) To determine the chemical structure of drugs
B) To study the release of drugs from dosage forms
C) To enhance drug excretion
D) To reduce drug metabolism
Correct Answer: B

83. Which factor can influence the bioavailability of a drug?
A) Drug formulation
B) Route of administration
C) First-pass metabolism
D) All of the above
Correct Answer: D

84. What does the term ‘therapeutic window’ refer to?
A) The range of drug concentration in the body that is effective
B) The minimum concentration of a drug required for effect
C) The maximum concentration of a drug before toxicity
D) The time required for a drug to reach its peak concentration
Correct Answer: A

85. Which formulation factor can affect the dissolution rate of a drug?
A) Particle size
B) Crystal form
C) Drug solubility
D) All of the above
Correct Answer: D

86. What is the term for the design and testing of drug formulations?
A) Pharmacokinetics
B) Biopharmaceutics
C) Pharmacodynamics
D) Pharmacogenomics
Correct Answer: B

87. Which parameter is measured to assess the extent of drug absorption?
A) Cmax
B) Tmax
C) AUC
D) T1/2
Correct Answer: C

88. What is the significance of the drug’s partition coefficient in biopharmaceutics?
A) It affects drug solubility
B) It influences drug absorption
C) It determines drug distribution
D) All of the above
Correct Answer: D

89. Which of the following is NOT a primary consideration in the design of a controlled-release drug formulation?
A) Drug half-life
B) Drug solubility
C) Drug color
D) Drug stability
Correct Answer: C

90. What is the goal of biopharmaceutical studies in drug development?
A) To understand drug interaction
B) To optimize drug efficacy and safety
C) To measure drug excretion
D) To analyze drug chemical structure
Correct Answer: B

91. What is bioequivalence?
A) Similar bioavailability between two drug formulations
B) Identical chemical composition of two drugs
C) Same therapeutic effect of two drugs
D) Equal cost of two drug products
Correct Answer: A

92. Which parameter is used to compare bioequivalence?
A) AUC
B) Cmax
C) Tmax
D) All of the above
Correct Answer: D

93. What is the primary purpose of bioequivalence studies?
A) To develop new drugs
B) To compare generic drugs with brand-name drugs
C) To assess drug safety
D) To determine drug dosage
Correct Answer: B

94. Which organization regulates bioequivalence studies in the United States?
A) FDA
B) WHO
C) EMA
D) NIH
Correct Answer: A

95. What is required for two drugs to be considered bioequivalent?
A) Same route of administration
B) Identical dosage form
C) Similar rate and extent of absorption
D) All of the above
Correct Answer: D

96. Which factor can affect the outcome of bioequivalence studies?
A) Subject variability
B) Drug formulation
C) Study design
D) All of the above
Correct Answer: D

97. What does the term ‘therapeutic equivalence’ refer to?
A) Bioequivalence plus same clinical effect and safety profile
B) Identical chemical composition
C) Same cost of two drug products
D) Same manufacturing process
Correct Answer: A

98. Which statistical method is commonly used in bioequivalence studies?
A) T-test
B) ANOVA
C) Chi-square test
D) Regression analysis
Correct Answer: B

99. Which agency provides guidelines for bioequivalence studies in Europe?
A) FDA
B) EMA
C) MHRA
D) ICH
Correct Answer: B

100. What is the importance of bioequivalence studies for generic drugs?
A) Ensures safety and efficacy similar to the brand-name drug
B) Reduces the cost of drug development
C) Facilitates faster approval process
D) All of the above
Correct Answer: D