Author(s): Shah Kalpesh*1, Kumar Sokindra2, Maheshwari Kamal Kishore3
The cost of healthcare has been escalating globally during the last two decades, and this has prompted efforts in most countries to reduce those costs. Because of the importance of generic drugs in healthcare, it is imperative that the pharmaceutical quality and in vivo performance of generic drugs be reliably assessed. Because generic drugs would be interchanged with innovator products in the market place, it must be demonstrated that the safety and efficacy of generics are comparable to the safety and efficacy of the corresponding innovator drugs. The concept of bioavailability (BA) and bioequivalence (BE) has been accepted worldwide by the pharmaceutical industry and national regulatory authorities for over 20 years and is applied to new as well as generic products. As a result, thousands of high-quality generic drugs at reduced costs have become available in every corner of the globe. The assessment of BE is not a simple issue, however, and much of the research has been done in recent years to develop new and more effective approaches to the assessment of BE. 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 requirements for conduct of BA/BE studies. In this article, the regulatory guidelines are compared on the basis of various parameters involving the clinical conduct of the BA/BE studies. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Another upcoming approach for conduct of bioequivalence studies is Adaptive design, which is a relatively new approach. This innovation is becoming accepted by the regulators and has been taken up by the pharmaceutical industry to reduce product development times and costs. There is a need for raising the awareness of these design approaches because they could be used to make dramatic improvements to clinical research in developing countries.