Bioequivalence and Bioavailability Forum

Thanks Helmut,
So you're saying that theoretically, BE can be concluded even after dose normalization on different dosage strengths - so long as the requirement for linear PK is fulfilled. In your experience though, it sounds like reg. agencies don't like this and would rather you match up the strengths with 2x, 3x etc doses. The problem I have is that I have different strengths that are not whole number multiples of each other, for example 10 mg vs 8 mg. In this case, maybe it is acceptable to dose normalize and declare BE (assuming linear PK of course). If, however, the 10 mg vs 8 mg are different formulations, then we can't dose normalize and assess BE since we don't know what impact the formulation differences can have on f (and linear PK may no longer hold). In this case, would we have to assess BE on non dose-normalized data?
Thanks again,
sciguy