Question

What is pharmaceutic equivalence?

(a) Two or more drug products contain the same labeled chemical substance in the same amount

(b) Two or more drug products are identical in quality, purity, uniformity, disintegration, dissolution

(c) Two or more drug products contain different labeled chemical substance giving the same therapeutic effect

(d) Two or more drug products contain the same labeled chemical substance giving a different therapeutic effect

I have been asked this question in an international level competition.

The origin of the question is Bioequivalence Studies in section Compartment Modelling, Non Linear Pharmacokinetics, Bioavailability and Bioequivalence of Drug Biotechnology

Answer 1

Correct answer is (b) Two or more drug products are identical in quality, purity, uniformity, disintegration, dissolution

The best explanation: Pharmaceutic equivalence implies that two or more drug products when they are identical in strength, purity, content uniformity, and disintegration and dissolution characteristics. Though the excipients may differ. Chemical equivalence of drug products is said when the drugs contain the same active ingredient. The amount of the active ingredient must be the same. When two or more drug products contain the same active ingredient giving the same pharmacologic effect is known as therapeutic equivalence.