Bioequivalence and Bioavailability Forum

Japanese Guideline of Bioequivalence [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2021-02-24 18:07 (51 d 11:59 ago) – Posting: # 22234
Views: 345

Hi Brus,

» 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?

You are aware that you are referring to a post which is whopping eleven years old?
The last time I’ve heard about this requirement was at the ‘EUFEPS/BABP Network Open Discussion Forum’ (Barcelona, 23/24 February 2011).
The Japanese guideline is of 2012…

 The Times They Are A-Changin’

If in doubt, see there.

—
Dif-tor heh smusma 🖖
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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 Bioequivalence Brus 2021-02-24 16:30
      • Japanese Guideline of BioequivalenceHelmut 2021-02-24 18:07
        • Japanese Guideline of Bioequivalence Brus 2021-02-25 11:46