The basic regulatory considerations and prospects for conducting bioavailability/bioequivalence (BA/BE) studies – an overview

Shaik Mastan¹, Thirunagari Bhavya Latha², Sathe Ajay^1
1Cytel Statistical Software and Services Pvt Ltd, Pune, Maharashtra, India; ²Business Development, Bioserve Clinical Research Pvt Ltd, Hyderabad, Andhra Pradesh, India

Abstract: Bioavailability (BA) and bioequivalence (BE) studies play a major role in the drug development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally. BE is a strategy to introduce generic equivalents of brand-name drugs (innovator drugs) to lower the cost of medication through proper assessment as directed by the international regulatory authorities. There are several approaches to assess BE and each regulatory authority has its own regulations/guidance for conducting BA/BE studies before approving generic products for marketing in their country. Therefore, a thorough understanding is required of these BA/BE concepts and basic regulatory considerations for conducting BA/BE studies. This article briefly reviews the BA/BE concepts, approaches, designs, and various basic regulatory considerations and prospects for conducting BA/BE studies.

Keywords: bioavailability, bioequivalence, generic drugs, regulatory authority, pharmacokinetics, pharmacodynamics