Bioequivalence in Japan [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-02-03 11:10 (4372 d 18:58 ago) – Posting: # 4698
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Dear Mangu

» Kindly provide the reasons (Provided by regulatory body) if you have, why only japanese population is required for the bioequivalence study, for the approval in japan market?

Please :google: (quickly)
Japanese are different in their genotypes of some enzymes, achlororhydria is (much!) more common than anywhere in the world, guidelines call for studies in fast metabolizers only (even in cross-over studies), etc....

» According to ICH E5, Is it not applicable to apply foreign clinical data in japan?

Yes it is applicable, but then you will have to perfom an additional bridging study as well!Do you like to do that?

Dif-tor heh smusma 🖖
Helmut Schütz
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