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.
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.