Bioequivalence and Bioavailability Forum

Hi Lucas,

❝ 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.

Phase III is done in patients (endpoints efficacy & safety), whereas BE mainly employs healthy subjects. If have seen many wordings in protocols. Some state Phase I (PK in healthy subjects), some I/IV (I for the test and IV for the reference), and some elegantly circumnavigate all terminology issues and state just “human pharmacology”. Pick whatever you like. You will not loose the war by using a “wrong” term.