Bioequivalence and Bioavailability Forum

Hello dear colleagues.

I have a doubt regarding to the classification of a bioequivalence study. We know that a BE study is a comparative pharmacokinetic assay that demonstrates, indirectly, the efficacy and safety of a new formulation, based on a comparator that already proved to be safe and effective through a series of studies in the development process (phases I, II, III, IV). So, would it be correct to say BE studies belongs to one of the 4 phases previously described? I’ve seen some researchers classifying BE as a phase I study, but I’m not so sure if that is, in concept, the correct classification or if BE can be classified in one of those 4 phases. IMHO if I had to classify BE in one of these 4 classes, I would say it is in “phase III” (for this is the phase in which comparative studies are made), specifically in terms of therapeutic equivalence. Would you please let me know your opinion in that matter?