Bioequivalence and Bioavailability Forum

Hi Detleffff,

❝ (blah blah blah)

❝ Further it is written: "… Usually the strategy with this design is to accept bioequivalence at the first stage and only go to the second stage when the intra-subject variance from the first stage is very large."

❝ That sounds to me like a negated futility criterion. Than it should read "to accept or reject bioequivalence at the first stage", I think. Anybody out there to shed some light on this? Does anybody know what is meant with "very large"? Is there an example anywhere?

I think not, at least not when we talk public domain. I believe HC's interpretation of the term "usually" means "without any precedence whatsoever". The term occurs several more times elsewhere in the document where it has a found a use that makes a bit more sense to me.

❝ Another sentence makes me also headache: "This method precludes the need for a stage effect in the model." Why this?

No idea.

I must admit that to me, the whole section 2.3.2.1. doesn't live any real life. It's the Potvin way or the highway.

Finally, check out the answer to question 9 here. You must give the agency some style points for creativity in their solutions to number-crunching issues. Perhaps the two documents are written by one and the same person?