Japanese Guideline of Bioequivalence [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-02-24 18:07 (158 d 12:34 ago) – Posting: # 22234
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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…

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If in doubt, see there. ;-)

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Helmut Schütz
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