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The following message was posted to: PharmPK
The draft guidance "Food-Effect Bioavailability and Bioequivalence Studies"
issued by CDER in 1997 states that lack of food effect may be declared when
the 90% CI for AUC falls within 80-125% and the corresponding CI for Cmax
falls within 70-143%.
However, in the more recent CDER guidance "Bioavailability and
Bioequivalence Studies for Orally Administered Drug Products - General
Considerations" issued 2000 the 80-125% interval is referred to for both AUC
and Cmax and this guidance also discusses food interactions.
My question is therefore whether 70-143% or 80-125% should be regarded as
the current standard CI when evaluating food effects on Cmax (maybe
different in Europe and the US), and whether certain considerations may
apply when choosing the interval.
Looking forward to response both from regulatory authorities and colleagues
in drug industry with recent experience on this issue.
Markus Jerling MD PhD
Senior Director of Clinical Research
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