Japanese Guideline of Bioequivalence [Regulatives / Guidelines]

posted by Brus – Spain, 2021-02-24 16:30 (51 d 14:39 ago) – Posting: # 22233
Views: 366

Dear Helmut,

» According to Japanese Guidelines subjects must be of 'Japanese ethnic origin' (no exceptions). If you want to perform a study ouside of Japan, I would suggest to go to Sao Paulo. You will find there they largest Japanese community (0.5 Mio) outside of Japan. There are a couple of CROs approved by the ANVISA specialized in these kinds of studies.

I have consulted the Japanese Bioequivalence guideline and I have not seen this mention. Where does this requirement come from? Where does it appear in the guideline or legislation?

Best regards,

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