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, N. Udupa

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)17-22
Number of pages6
JournalJournal of Bioanalysis and Biomedicine
Volume2
Issue number1
DOIs
Publication statusPublished - 02-2010

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

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