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The following message was posted to: PharmPK
I would like to know the FDA's perspective on the submission of Food
effect Bioequivalence studies,and the data required.
I have found some differences in the content relevant to
BioEquivalence (BE) studies in the ANDA applications submitted
through different CRO's, as some CRO's generate data as mean values
and Test/Referenceratios, whereas some submitt the 90% Confidence
Intervals also. Of course this is in addition to the Fasting state
single dose crossover BE studies where the 90% C.I of the Pk
parameters is the deciding the out come of Bioequivalence study.
I appreciate response from CDER members about the exact requirement.
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