About Author: 1. Shah Dhaval D., M.Pharm-II Semester, Quality Assurance Department, Gyan Vihar School of Pharmacy, Jaipur, India
2. Sharma Anil, M.Pharm, H.O.D. Quality Assurance Department, Gyan Vihar School of Pharmacy, Jaipur, India
Reference ID: PHARMATUTOR-ART-1050
Generic pharmaceutical products need to confirm to the same standard of quality, efficacy and safety as required of the originator’s (innovator) product. Spefically, the generic product should be therapeutically equivalent and interchangable with the reference product. Testing the bioequivalence between a test product pharmacetically equivalent or a pharmaceutical alternative and a suitable reference product in a pharmacokinetic study with a limited no 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 article provides the information about important aspect involved in bioequivalence and regulatory requirment for bioequivalence study.