Japanese Guideline of Bioequivalence [Regulatives / Guidelines]

posted by Brus – Spain, 2021-02-24 16:30 (336 d 17:53 ago) – Posting: # 22233
Views: 795

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,

Complete thread:

Activity
 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 20 (0 registered, 20 guests [including 11 identified bots]).
Forum time: Thursday 10:24 CET (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5