Question

What is bioequivalence?

(a) Drug substance reaches the systemic circulation at the same rate in two or more identical dosage

(b) Two or more drug products contain the same labeled chemical substance in different quantity

(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 had been asked this question by my college professor while I was bunking the class.

The above asked question is from Bioequivalence Studies topic in portion Compartment Modelling, Non Linear Pharmacokinetics, Bioavailability and Bioequivalence of Drug Biotechnology

Answer 1

Right option is (a) Drug substance reaches the systemic circulation at the same rate in two or more identical dosage

To explain I would say: Bioequivalence is a relative term which denotes that the drug substance reaches the systemic circulation at the same relative rate or time and to the same extent when given in two or more identical dosage. That is their plasma level concentration-time profile will be identical without significant statistical differences.