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

Jamadar, Latif D and Bhat, Krishnamurthy and Shirode, Yogesh and Musmade, Prashant B and Hussen, Syed Sajjad and Udupa, N (2010) Comparison of US and Japanese Regulations for Invitro Dissolution and Invivo Bioequivalence Studies. Journal of Bioanalysis & Biomedicine, 2 (1). pp. 17-22.

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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.

Item Type: Article
Uncontrolled Keywords: US FDA; NIHS; Invitro; Biowaiver; Post approval changes; Study reports
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Depositing User: KMC Manipal
Date Deposited: 21 Apr 2012 06:47
Last Modified: 21 Apr 2012 06:47
URI: http://eprints.manipal.edu/id/eprint/76278

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