yes Comparison of US and Japanese Regulations for Invitro Dissol | 26817
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Revista de bioanálisis y biomedicina

ISSN: 1948-593X

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

Abstract

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

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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