Bioequivalence and Bioavailability Forum

Dear Helmut!

❝ ... But I’m pretty sure the partial replicate is crap.

That's a sort of political incorrect statement about someone who can't answer back .

I'm not "pretty sure" if you are right here. In my opinion it is crap that the FDA insists on using the SAS Proc Mixed code for full replicate designs also for the partial replicate design.

I always wondered why. When it comes to the scaled ABE evaluation they don't use it but revert to the evaluation of the scaled ABE criterion via intra-subject contrasts. Why not use them also for ABE if the criteria for scaling are not fulfilled? Ok, missings or imbalance may have an impact on the ABE decision if one uses this (method of moments) method. But this also applies if scaling is allowed since the ABE criterion is integral part of the scaled ABE criterion.

So why do they insist on using the SAS Proc Mixed code for the ABE decision? Sort of political correctness because it has a long history being published already in 2001 for ABE?
And do they really insist? Or are other models (beside FA0(1) we have additionally this one) also acceptable if described properly? As I see this: No one knows at the moment. May be it would help if not only John is asking them.

IMHO the partial replicate design itself is not worse or better than others, if evaluated properly and not literally.