The basic regulatory considerations and prospects for conducting bioavailability/bioequivalence (BA/BE) studies – an overview
Shaik Mastan1, Thirunagari Bhavya Latha2, Sathe Ajay1
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
© 2011 The Author(s). This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.