Revista de bioanálisis y biomedicina

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.