Japanese Guideline of Bioequivalence [Regulatives / Guidelines]
❝ 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?
- Japan BE requirement mangurohit 2010-02-02 09:20 [Regulatives / Guidelines]
- Brazil's CROs Helmut 2010-02-02 15:03