| Review Article |
Open Access |
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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: asiftamboli2008@rediffmail.com
asiftamboli2008@gmail.com |
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| Received August 16, 2010; Accepted September 06, 2010; Published September 06, 2010 |
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| 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 |
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| 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. |
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| Abstract |
| 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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