Bioequivalence and Bioavailability Forum • Japanese Guideline of Bioequivalence

Japanese Guideline of Bioequivalence [Regulatives / Guidelines]

posted by Brus – Spain, 2021-02-24 17:30 (761 d 21:45 ago) – Posting: # 22233
Views: 1,093

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:

Japan BE requirement mangurohit 2010-02-02 09:20 [Regulatives / Guidelines]
- Brazil's CROs Helmut 2010-02-02 15:03
  - Bioequivalence in Japan mangurohit 2010-02-03 05:21
    - Bioequivalence in Japan Helmut 2010-02-03 11:10
  - Japanese Guideline of BioequivalenceBrus 2021-02-24 16:30
    - Japanese Guideline of Bioequivalence Helmut 2021-02-24 18:07
      - Japanese Guideline of Bioequivalence Brus 2021-02-25 11:46