Question

If the bioavailability of test formulation is 80-120% of the reference standard, it is considered to be bioequivalent.

(a) True

(b) False

The question was asked in an interview.

This interesting question is from Bioequivalence Studies in section Compartment Modelling, Non Linear Pharmacokinetics, Bioavailability and Bioequivalence of Drug Biotechnology

Answer 1

Correct option is (a) True

Easy explanation: A significant difference of 10% in the extent of absorption between the two formulations is clinically insignificant. Thus, a rule is that if the relative bioavailability of the test formulation is in the range 80-120% 0f reference standard, it is considered to be bioequivalent.