Bioequivalence and Bioavailability Forum

Hi Jerry,

❝ In the above quote, is it statistically valid to establish ANOVA using drugs A and B only (as if done like a 2-way 2-seq crossover) in stage 1 (Potvin Method C) even though the study was done on a 3-way 6-seq crossover (Williams design) with drugs A, B and C? (asssuming the protocol specifically states that sequential BE shall be done on drugs A and B only; drug C shall be done for descriptive statistics determination only). Also, may I ask what specific EMA guideline mentioned the above approach so I could explore the topic further. I know a lot of discussion has already been poured on sequential BE, but I couldn't find a specific answer to my query. Many thanks in advance!

Yes, I would assume you can actually do that across some of the EU agencies.
But how could you ever be in a situation where you'd wish to study a third product descriptively in a form of BE trial? Not sure I get everything here, and if you are asked how this approach influences the type I error do you have a good answer prepared?