PharmPK Discussion - Bioequivalence criteria

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On 10 Jan 2000 at 21:49:09, Korbtham Sathirakul (pyksk.at.mahidol.ac.th) sent the message


Dear All
I would like to get the refernce for the bioequivalence criteria in
europe. When I looked to the Kinetica manual. It is mentioned that the
confidence interval for log transformation required in Europe is 0.7
1.43. I tried to find from EMEA website but could not find this criteria.
If somebody know the original reference the Kinetica program used, would
you mind telling me? Thank a lot.
Korbtham
Mahidol University
Bangkok, Thailand

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