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An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products

Asif M. Tamboli, Pavan Todkar, Priti Zope and F.J. Sayyad

Generic pharmaceutical products need to con fi rm to the same standards of quality, ef fi cacy and safety as required of the originator’s (innovator) product. Speci fi cally, the Generic product should be therapeutically equivalent and interchangeable with the reference product. Testing the bioequivalence between a test product pharmaceutically equivalent or a pharmaceutical alternative and a suitable reference product in a pharmacokinetic study with a limited number of subjects is one way of demonstrating therapeutic equivalence. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. This paper provides the information about important aspect involved in bioequivalence and Regulatory requirement for Bioequivalence study.