Biopharmaceutical properties determine how drug substances behave in biological systems, impacting absorption, distribution, metabolism, and excretion. These properties are essential for optimizing drug dosage forms, delivery routes, and therapeutic outcomes. This quiz is designed according to Pharm.D. curriculum standards, especially from PHA5176 and PHA5439, and evaluates your knowledge of ADME, bioavailability, and formulation science.
1. What does the term “biopharmaceutics” refer to?
- A. Study of drug chemical synthesis
- B. Study of drug effects on microorganisms
- C. Study of drug absorption, distribution, metabolism, and excretion
- D. Study of drug pricing and marketing
Correct answer: C. Study of drug absorption, distribution, metabolism, and excretion
2. Bioavailability refers to:
- A. Speed of drug metabolism
- B. Percentage of unchanged drug reaching systemic circulation
- C. Drug degradation rate
- D. Drug half-life
Correct answer: B. Percentage of unchanged drug reaching systemic circulation
3. Which of the following routes of administration bypasses the first-pass effect?
- A. Oral
- B. Sublingual
- C. Rectal
- D. Intramuscular
Correct answer: B. Sublingual
4. The term “Cmax” refers to:
- A. Maximum tolerated dose
- B. Maximum serum concentration of a drug
- C. Maximum clearance rate
- D. Maximum renal elimination
Correct answer: B. Maximum serum concentration of a drug
5. Which parameter reflects the total drug exposure over time?
- A. Tmax
- B. Cmax
- C. AUC (Area Under Curve)
- D. Bioequivalence
Correct answer: C. AUC (Area Under Curve)
6. What is the main purpose of studying biopharmaceutical properties?
- A. To reduce drug cost
- B. To determine shelf-life
- C. To optimize drug therapy and formulation
- D. To ensure drug color uniformity
Correct answer: C. To optimize drug therapy and formulation
7. The term “bioequivalence” refers to:
- A. Chemical similarity between two drugs
- B. Therapeutic index similarity
- C. Comparable bioavailability and pharmacokinetic profiles
- D. Identical chemical structure
Correct answer: C. Comparable bioavailability and pharmacokinetic profiles
8. Which organ is primarily responsible for drug metabolism?
- A. Kidney
- B. Liver
- C. Intestine
- D. Lungs
Correct answer: B. Liver
9. Which of the following best defines the term “half-life (t½)”?
- A. Time to reach peak drug concentration
- B. Time for drug to dissolve in solution
- C. Time required for the drug concentration to reduce by half
- D. Time required for drug excretion
Correct answer: C. Time required for the drug concentration to reduce by half
10. Which factor most affects oral drug absorption?
- A. Drug color
- B. Lipophilicity
- C. Boiling point
- D. Odor
Correct answer: B. Lipophilicity
11. What does the Biopharmaceutics Classification System (BCS) classify drugs by?
- A. Bioavailability and potency
- B. Route of administration
- C. Solubility and permeability
- D. Enzyme interaction
Correct answer: C. Solubility and permeability
12. A BCS Class I drug is characterized by:
- A. Low solubility, high permeability
- B. High solubility, high permeability
- C. Low solubility, low permeability
- D. High solubility, low permeability
Correct answer: B. High solubility, high permeability
13. What is the “first-pass effect”?
- A. First excretion of drug in urine
- B. Initial drug effect observed in patients
- C. Metabolism of drug in liver before reaching systemic circulation
- D. Rapid onset of action
Correct answer: C. Metabolism of drug in liver before reaching systemic circulation
14. Which formulation factor enhances drug bioavailability?
- A. High particle size
- B. Poor solubility
- C. Use of solubilizers
- D. Low permeability
Correct answer: C. Use of solubilizers
15. What role does P-glycoprotein play in drug disposition?
- A. Enhances drug solubility
- B. Promotes drug absorption
- C. Pumps drugs out of cells, reducing absorption
- D. Converts prodrugs to active form
Correct answer: C. Pumps drugs out of cells, reducing absorption
16. Tmax is defined as:
- A. Time of maximum clearance
- B. Time of peak plasma drug concentration
- C. Total maximum dose
- D. Time to complete elimination
Correct answer: B. Time of peak plasma drug concentration
17. Which of the following is considered a biopharmaceutical property?
- A. Drug melting point
- B. Drug price
- C. Drug permeability
- D. Drug chemical formula
Correct answer: C. Drug permeability
18. The extent of drug distribution is best represented by:
- A. AUC
- B. Clearance
- C. Volume of distribution (Vd)
- D. Tmax
Correct answer: C. Volume of distribution (Vd)
19. Which route of administration offers 100% bioavailability?
- A. Oral
- B. Rectal
- C. Intravenous
- D. Transdermal
Correct answer: C. Intravenous
20. What is the impact of increased gastric emptying time on drug absorption?
- A. Increases absorption rate
- B. Delays absorption
- C. Improves drug potency
- D. Increases drug metabolism
Correct answer: B. Delays absorption
21. Poor aqueous solubility of a drug usually results in:
- A. Enhanced bioavailability
- B. Reduced oral absorption
- C. High renal clearance
- D. Long half-life
Correct answer: B. Reduced oral absorption
22. The therapeutic effect of a drug is influenced by its:
- A. Color and shape
- B. Pharmacokinetics and pharmacodynamics
- C. Cost
- D. Manufacturing location
Correct answer: B. Pharmacokinetics and pharmacodynamics
23. Which organ is primarily responsible for drug excretion?
- A. Liver
- B. Lung
- C. Kidney
- D. Skin
Correct answer: C. Kidney
24. What determines the rate of drug diffusion across membranes?
- A. Temperature and humidity
- B. Concentration gradient and lipid solubility
- C. Route of synthesis
- D. Marketing formulation
Correct answer: B. Concentration gradient and lipid solubility
25. What happens to a highly lipophilic drug in the body?
- A. Rapidly eliminated by kidneys
- B. Accumulates in fat tissues
- C. Quickly deactivated
- D. Forms insoluble salts
Correct answer: B. Accumulates in fat tissues
26. Clearance refers to:
- A. Amount of drug bound to protein
- B. Volume of plasma cleared of drug per unit time
- C. Drug’s absorption rate
- D. Protein binding rate
Correct answer: B. Volume of plasma cleared of drug per unit time
27. What is the main barrier to oral drug absorption?
- A. Gastric pH
- B. Intestinal pH
- C. Epithelial cell membrane
- D. Bile salts
Correct answer: C. Epithelial cell membrane
28. Bioavailability is reduced when a drug:
- A. Has high first-pass metabolism
- B. Is highly water soluble
- C. Is administered intravenously
- D. Has low volume of distribution
Correct answer: A. Has high first-pass metabolism
29. The steady-state concentration of a drug depends on:
- A. Lipophilicity
- B. Clearance and dosing rate
- C. Molecular weight
- D. Ionization
Correct answer: B. Clearance and dosing rate
30. Which of the following increases permeability of a drug?
- A. Ionization
- B. High polarity
- C. Unionized, lipophilic form
- D. Salt formation
Correct answer: C. Unionized, lipophilic form
31. A high Vd suggests that the drug:
- A. Remains in the plasma
- B. Accumulates in the tissues
- C. Is rapidly excreted
- D. Is poorly absorbed
Correct answer: B. Accumulates in the tissues
32. The pKa of a drug helps determine its:
- A. Dosage form
- B. Ionization state at a given pH
- C. Color
- D. Packaging material
Correct answer: B. Ionization state at a given pH
33. Drug absorption from the GI tract is optimal when the drug is:
- A. Polar and ionized
- B. Lipophilic and unionized
- C. Large and charged
- D. Hydrophilic and basic
Correct answer: B. Lipophilic and unionized
34. The rate-limiting step in drug dissolution is often:
- A. Stability
- B. Surface area of the drug
- C. Permeability
- D. Dose size
Correct answer: B. Surface area of the drug
35. AUC is used to assess:
- A. Rate of drug metabolism
- B. Bioequivalence
- C. Ionization of drugs
- D. Protein binding
Correct answer: B. Bioequivalence
36. What does “flip-flop kinetics” refer to?
- A. Faster elimination than absorption
- B. Faster absorption than elimination
- C. Equal absorption and elimination
- D. Reabsorption of drug
Correct answer: A. Faster elimination than absorption
37. Controlled-release formulations aim to:
- A. Increase cost
- B. Improve taste
- C. Provide constant drug levels over time
- D. Delay absorption indefinitely
Correct answer: C. Provide constant drug levels over time
38. A highly protein-bound drug will have:
- A. High renal clearance
- B. Low tissue binding
- C. Long half-life
- D. Low bioavailability
Correct answer: C. Long half-life
39. Poor permeability is a characteristic of BCS class:
- A. I
- B. II
- C. III
- D. IV
Correct answer: C. III
40. In biopharmaceutics, dissolution refers to:
- A. Solubilizing the drug in solvents
- B. Degradation of the drug
- C. Drug molecules going into solution
- D. Disintegration of tablets only
Correct answer: C. Drug molecules going into solution
41. What is the main influence of food on drug absorption?
- A. Enhances color
- B. Alters gastric emptying and pH
- C. Speeds drug metabolism
- D. Removes drug coating
Correct answer: B. Alters gastric emptying and pH
42. What effect does a high-fat meal have on lipophilic drugs?
- A. Decreases bioavailability
- B. Increases gastric motility
- C. Increases bioavailability
- D. Slows metabolism
Correct answer: C. Increases bioavailability
43. Biopharmaceutical considerations are critical during:
- A. Marketing
- B. Formulation development
- C. Drug pricing
- D. Patent filing
Correct answer: B. Formulation development
44. What is a major limitation of intravenous administration?
- A. Unpredictable absorption
- B. First-pass effect
- C. Risk of infection and cost
- D. Poor onset
Correct answer: C. Risk of infection and cost
45. Drugs with poor permeability may benefit from:
- A. Larger particle size
- B. Sustained-release formulations
- C. Absorption enhancers or prodrugs
- D. Acidic environment
Correct answer: C. Absorption enhancers or prodrugs
46. The bioavailability of a sublingual drug is typically:
- A. Lower than oral
- B. Zero
- C. Higher due to bypassing first-pass metabolism
- D. Dependent on color
Correct answer: C. Higher due to bypassing first-pass metabolism
47. The renal clearance of a drug is influenced by:
- A. Its Log P
- B. Its protein binding
- C. Its melting point
- D. Its chemical name
Correct answer: B. Its protein binding
48. Drug interactions at the transporter level affect:
- A. Formulation stability
- B. Drug absorption and excretion
- C. Route of synthesis
- D. Melting point
Correct answer: B. Drug absorption and excretion
49. Biopharmaceutical properties directly influence:
- A. Tablet color
- B. Clinical efficacy and safety
- C. Market approval
- D. Advertising strategy
Correct answer: B. Clinical efficacy and safety
50. What is the ideal outcome of optimized biopharmaceutical properties?
- A. Faster manufacturing
- B. Improved therapeutic response
- C. Reduced chemical complexity
- D. Enhanced taste
Correct answer: B. Improved therapeutic response