Bayesian Approach to Establish Bioequivalence: Why and How?

A generic drug that is legally substitutable for its brand name predecessor drug (reference-listed drug (RLD)) is expected to be therapeutically equivalent (TE). Bioequivalence (BE) is a core requirement for TE and is established by statistical analysis of data in a small pharmacokinetic trial. Below, we discuss some concerns with the current statistical procedure used in this analysis and propose evaluation of a robust Bayesian approach to mitigate them.