B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) 5

Question 1

Which regulatory body in the United States is responsible for approving new drug applications (NDAs)?

Accepted Answer

FDA (Food and Drug Administration)

Answer

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?

Accepted Answer

Schedule II

Answer

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?

Accepted Answer

Oil-in-water (O/W)

Answer

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:

Accepted Answer

Pharmaceutical equivalence and bioequivalence

Answer

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?

Accepted Answer

Volume of distribution (Vd)

Answer

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.

B.Pharm. Bachelor of Pharmacy Practice Test

B.Pharm. Bachelor of Pharmacy Practice Test

B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) 5