Bioequivalence and Bioavailability Forum

Ah,

it is all coming together now.

Thanks sweiner,
this is a great question.

» In a 5-way BE crossover trial, is there a methodology available that allows one to analyze 3 out of 5 sequences for BE in an interim fashion, and contingent upon results complete the remaining 2 sequences and analyze all 5 sequences at the conclusion?

Should read: "In a 5-way BE crossover trial, is there a methodology available that allows one to analyze 3 out of 5 periods for BE in an interim fashion, and contingent upon results complete the remaining 2 periods and analyze all 5 periods at the conclusion?"

This is an interesting idea, one that has not been explored much yet in the public domain; I think a few other sponsors have used it.
It is definitely doable as a single protocol. It is in fact what other companies / sponsors are achieving with two separate studies. Just do it, I think it may not require much operational adjustment or statistical fiddling, unless you can say you will switch to another formulation and re-start another 5-period trial once the first formulation fails after 3 periods.

A great post, in my opinion.