Bioequivalence and Bioavailability Forum

Kindly provide your inputs for the following issue,

During subject analysis of Antipsychotic drug in BE studies, three subject were showing concentration more than 5 % of Cmax value in the predose samples of period 1

Please let me know whether these three subjects should be included in statistical analysis or should be excluded?

since ANVISA guideline does not say regarding the inclusion & exclusion for the above issue,

whereas USFDA & EMEA guideline says that,

If the predose concentration is ≤ 5 percent of Cmax value in that subject, the subject’s data without any adjustments can be included in all pharmacokinetic measurements and calculations. We recommend that if the predose value is > than 5 percent of Cmax, the subject be dropped from all BE study evaluations.


Since above study is for ANVISA scope,

Please let me know your opinion.

Thanks & Best Regards

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Edit: Category changed. [Helmut]