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ISSN: 1948-593X

Journal of Bioanalysis & Biomedicine
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Research Article

Comparison of US and Japanese Regulations for Invitro Dissolution and Invivo Bioequivalence Studies

Latif D. Jamadar*, Krishnamurthy Bhat, Yogesh Shirode, Prashant B. Musmade, Syed Sajjad Hussen and N. Udupa

Manipal College of Pharmaceutical Sciences, Manipal, Karnataka-576104, India

*Corresponding Author:
Latif D. Jamadar,
Mitraprem Hsg, Soc, Flat No: 1, Plot No: RH 66/1, MIDC, G BLOCK,
Chinchwad, Pune-411019 Maharashtra, India,
Tel: +919552495853, +919164563678;
E-mail: [email protected]

Received Date: February 16, 2010; Accepted Date: March 14, 2010; Published: March 14, 2010

Citation: Jamadar LD, Bhat K, Shirode Y, Musmade PB, Hussen SS, et al. (2010) Comparison of us and Japanese Regulations for Invivo Dissolution and Invivo Bioequivalence Studies. J Bioanal Biomed 2:017-022. doi: 10.4172/1948-593X.1000016

Copyright: © 2010 Jamadar LD, 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.

Abstract

A regulation with respect to bioequivalence and invitro dissolution of solid oral dosage forms in USA and Japan is summarized and compared. Significant differences in vari- ous parameters like dissolution, biowaiver, inclusion- ex- clusion criteria of subjects in the clinical trials, statistical results were found between two systems. The regulatory experienced gained up to now is studied and compared.

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