Bioequivalence Study: Concepts, Approaches, Design, Various Regulatory Prospects and Considerations

The study of bioequivalence involves comparing various drug brands and their dosage forms. When the rate of dissolution and absorption of two different formulations of the same drug is identical, they are bioequivalent. Comparing the therapeutic effectiveness of two drugs that have the same active ingredient is necessary to assess the possibility of replacing an innovator with similar pharmaceuticals. Conducting a bioequivalence study involves conducting two methods: in-vitro and in-vivo. In-vivo bioequivalence study is usually carried out in human and animal subjects by measuring the rate and extent of drug absorption in the blood stream after a drug has been administered. Highly reliable information can be obtained from in-vivo studies. Furthermore, living organisms have a greater degree of variability. Conducting multiple trials is necessary, and the cost is also important. A dissolution apparatus is used for in-vitro bioequivalence studies. The necessary biological conditions are provided and samples are collected and analysed on a periodic basis. The system can be controlled by conducting in-vitro studies. It also allows for the imitation of biological conditions. By using in-vitro studies, the cost and number of trials can be decreased. The pharmaceutical industry and national regulatory authorities worldwide have embraced the concept of “BE”. Efforts are being made to understand and develop more effective and scientifically valid approaches to assess bioequivalence of various dosage forms. This article provides a brief review of the BE concepts, approaches, designs, and various basic regulatory considerations and prospects for conducting BE studies.