TY - JOUR
T1 - Comparison of US and Japanese regulations for invitro dissolution and invivo bioequivalence studies
AU - Jamadar, Latif D.
AU - Bhat, Krishnamurthy
AU - Shirode, Yogesh
AU - Musmade, Prashant B.
AU - Hussen, Syed Sajjad
AU - Udupa, N.
PY - 2010/2
Y1 - 2010/2
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=79952607845&partnerID=8YFLogxK
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U2 - 10.4172/1948-593X.1000016
DO - 10.4172/1948-593X.1000016
M3 - Article
AN - SCOPUS:79952607845
SN - 1948-593X
VL - 2
SP - 17
EP - 22
JO - Journal of Bioanalysis and Biomedicine
JF - Journal of Bioanalysis and Biomedicine
IS - 1
ER -