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 Research Article Open Access 
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: latifsigma@gmail.com
 
Received February 16, 2010; Accepted 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 Invitro 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 various parameters like dissolution, biowaiver, inclusion- exclusion 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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