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An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products

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Author(s): Asif M. Tamboli | Pavan Todkar | Priti Zope | F.J. Sayyad

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 02;
Issue: 04;
Start page: 086;
Date: 2010;
Original page

Keywords: US FDA | EMEA | MCC | Body mass index | Confidence interval | AUC

ABSTRACT
Generic pharmaceutical products need to confi rm to the same standards of quality, effi cacy and safety as requiredof the originator’s (innovator) product. Specifi cally, the Generic product should be therapeutically equivalent andinterchangeable with the reference product. Testing the bioequivalence between a test product pharmaceuticallyequivalent or a pharmaceutical alternative and a suitable reference product in a pharmacokinetic study with a limitednumber 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 andeffectiveness. This paper provides the information about important aspect involved in bioequivalence and Regulatoryrequirement for Bioequivalence study.
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