| Research Article |
Open Access |
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| 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 |
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| Received February 16, 2010; Accepted March 14, 2010; Published March 14, 2010 |
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| 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 |
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| 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. |
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| 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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