PharmPK Discussion - EC Bioequivalence

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On 20 Sep 2000 at 16:01:43, Wellington (gton.-at-.usp.br) sent the message


Could you send me some information (reference) about the bioequivalence
range  0.7-1.43 to Cmax , proposed by the European Community.
Thanks!
Wellington

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On 8 Oct 2000 at 20:02:50, "natrajan k" (natrajan69.aaa.rediffmail.com) sent the message


Dear Dr Wellington,

I may not have the specific reference to your query but certainly do
have something to add on it.Is the Cmax limit, which you say, that EC
has proposed ,for a fasted or fed state study.?If its for the latter
then it is similar to the one (tentatively)proposed by USFDA which
says that a no-food-effect can be concluded when the 90% CI for the
ratio of means of the test and RLD fall within 80-125% (for AUC) and
70-143%(for Cmax).That means that both the regulatory bodies are in
concurrence on the issue.But if the limits are for a fasted study
then there has to be a strong rationale behind EC' using such a wider
BE limit.

Thanks

K.Natrajan

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