Bioequivalence studies are part of clinical research, where the systemic exposure of test and reference compounds are compared. Drug development is an expensive process with a high failure rate. Reformulated or generic drugs can be manufactured and marketed through bioequivalence study design, without the need to demonstrate therapeutic equivalence in clinical trials, given they are benchmarked against an approved product. The objective of BA/BE studies in clinical trials is to evaluate the rate and extent of absorption of a drug from a test formulation. Bioequivalence and bioavailability studies are essential in early (Pilot Bioequivalence) and late (Pivotal Bioequivalence) clinical development of drug candidates. Generally, BE studies are performed if there is a change in dose formulation, salt forms, or manufacturing process.