Journal of Bioequivalence & Bioavailability

Abstract

Nontraditional Study Designs for Proving Bioequivalence

Sneha Latha

From past many years, concerns have been expressed regarding meeting the standard bioequivalence (BE) criteria for highly variable drugs. This has been point of discussion in many conferences and meetings. But to date there is no as such regulatory definition for these drugs or drug products. To pass conventional goal posts for these drugs, the number of subjects required for a study can be much higher than normally needed for a typical BE study. The resources required and the ethical concerns of exposing large number of healthy volunteers to a test drug further poses challenge to the suitability of conventional BE criteria (with an 80-125% acceptance range) for highly variable drugs. Examples exist where a highly variable reference product failed to demonstrate BE when compared to itself in a bioequivalent study using the standard design/sample size.