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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
Government College of pharmacy Vidynagar Karad, Maharashatra-415110,India
*Corresponding author: Dr. Asif M. Tamboli
538, Peth Bhag Gavali Galli
Sangli-416416 Maharashtra, India
Tel: +919028906245; +919960552578
E-mail: [email protected]
[email protected]
Received August 16, 2010; Accepted September 06, 2010; Published September 06, 2010
Citation: Tamboli AM, Todkar P, Zope P, Sayyad FJ (2010) An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products. J Bioequiv Availab 2: 086-092. doi:10.4172/jbb.1000037
Copyright: © 2010 Tamboli AM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Generic pharmaceutical products need to confirm to the same standards of quality, efficacy and safety as required of the originator’s (innovator) product. Specifi 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.
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