Bioequivalence and Bioavailability Forum

Hi everyone,

I was just going through some historical studies here (studies done before my time) and noticed a few BE studies involving 2 groups of subjects (due to clinic size, study recruitment issues). Being a nosy person, I looked into the SAS output from those studies in detail and noticed that group effect was not included in the model. I always incorporate group effect in the GLM /Mixed model but I am just curious if it is necessary from a regulatory perspective.

Studies were done in same clinic, just different time (1-2 weeks apart between groups).

Thanks
John