Bioequivalence and Bioavailability Forum

Hi mittiry,

The Guideline states that you should first investigate without the interaction term, not that you shouldn't include it in the model. That is more relevant for therapeutic studies IMO. For bioequivalence, at least as I saw it, centre effect it's just like group effect. I would however pray for not having a significant formulation*centre effect.

Additionally, I think the term period*centre is irrelevant and without any practical significance. The term for centre and centre*formulation already catch some of that variation anyway. But as always, you never know what is in the mind of the regulator. Period + Sequence + Formulation + Centre + Centre*formulation + Centre*Period + Subject(sequence*period)...

@BE-Proff never submitted a study including group effect. We had groups sometimes, however it was decided not to include group effects since groups were separated by just a few days, no randomization was stratified by group and it was the same Unit performing the study.