B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) 5 — Questions and Answers
Question 1: Which regulatory body in the United States is responsible for approving new drug applications (NDAs)?
- DEA (Drug Enforcement Administration)
- CDC (Centers for Disease Control)
- FDA (Food and Drug Administration) (Correct answer)
- NIH (National Institutes of Health)
Correct answer: FDA (Food and Drug Administration)
The FDA's Center for Drug Evaluation and Research (CDER) reviews and approves New Drug Applications submitted by pharmaceutical manufacturers.
Question 2: In which schedule (DEA) would you find drugs with accepted medical use but high potential for abuse, such as oxycodone?
- Schedule I
- Schedule II (Correct answer)
- Schedule III
- Schedule IV
Correct answer: Schedule II
Schedule II drugs have a high potential for abuse, accepted medical use, and may lead to severe psychological or physical dependence, requiring triplicate prescriptions with no refills.
Question 3: Which type of emulsion is typically preferred for oral pharmaceutical preparations?
- Water-in-oil (W/O)
- Oil-in-water (O/W) (Correct answer)
- Multiple emulsions (W/O/W)
- Microemulsions only
Correct answer: Oil-in-water (O/W)
Oil-in-water emulsions are preferred orally because water is the continuous phase, making them more palatable and compatible with GI fluids.
Question 4: The concept of 'therapeutic equivalence' between a generic and brand-name drug requires:
- Identical drug molecule and identical excipients
- Pharmaceutical equivalence and bioequivalence (Correct answer)
- Same manufacturer and same color
- Same route of administration and same indication only
Correct answer: Pharmaceutical equivalence and bioequivalence
Therapeutic equivalence requires that two products be pharmaceutically equivalent (same active ingredient, dose, and dosage form) and bioequivalent (similar rate and extent of absorption).
Question 5: Which pharmacokinetic parameter best describes the apparent volume in which a drug is distributed throughout the body?
- Clearance (CL)
- Half-life (t½)
- Volume of distribution (Vd) (Correct answer)
- Bioavailability (F)
Correct answer: Volume of distribution (Vd)
Volume of distribution (Vd) relates the amount of drug in the body to the plasma concentration, reflecting how extensively a drug distributes into tissues versus staying in plasma.
Question 6: Which immunosuppressant drug used in organ transplantation works by inhibiting calcineurin?
- Azathioprine
- Mycophenolate mofetil
- Cyclosporine (Correct answer)
- Sirolimus
Correct answer: Cyclosporine
Cyclosporine inhibits calcineurin, a phosphatase needed for T-cell activation, thereby suppressing the immune response and preventing organ rejection.
Question 7: What does the term 'osmolarity' refer to in the context of parenteral pharmaceutical solutions?
- The viscosity of the solution
- The number of osmoles of solute per liter of solution (Correct answer)
- The pH of the solution
- The tonicity relative to blood plasma only
Correct answer: The number of osmoles of solute per liter of solution
Osmolarity refers to the concentration of osmotically active particles (osmoles) per liter of solution, which determines the osmotic pressure of parenteral preparations.
B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) 5
Which regulatory body in the United States is responsible for approving new drug applications (NDAs)?