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

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Therapeutic Equivalency
Dosage Forms
Japan
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

Cite this

Jamadar, Latif D. ; Bhat, Krishnamurthy ; Shirode, Yogesh ; Musmade, Prashant B. ; Hussen, Syed Sajjad ; Udupa, N. / Comparison of US and Japanese regulations for invitro dissolution and invivo bioequivalence studies. In: Journal of Bioanalysis and Biomedicine. 2010 ; Vol. 2, No. 1. pp. 17-22.
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Comparison of US and Japanese regulations for invitro dissolution and invivo bioequivalence studies. / Jamadar, Latif D.; Bhat, Krishnamurthy; Shirode, Yogesh; Musmade, Prashant B.; Hussen, Syed Sajjad; Udupa, N.

In: Journal of Bioanalysis and Biomedicine, Vol. 2, No. 1, 02.2010, p. 17-22.

Research output: Contribution to journalArticle

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