Bioequivalence and Bioavailability Forum

❝ At least if your drug shows linear pharmacokinetics within 130 mg and 200 mg you may perfom a comparative bioavailability study and normalize dose-dependent PK parameters of the 200 mg formulation to 130 mg; but remember, this is not BE.

Dear Helmut,

In different references we come across, various researchers have used the terms "comparative bioavailability" and "bioequivalence" for the similar studies. However, as far as i understand, these imply to different kind of studies. the former (C BA) referring to all the studies involving comparison of bioavailability, while latter one (BE) refer to only those where a test product is being compared with the innovator's formulation (having same molar dose) only. This implies that, if we are comparing two generic products, the study should be termed as comparative bioavailability, not bioequivalence study. How about it?
Can we say that all BE studies are comparative BA studies, but all comparative BA studies are not BE? or,
Can we use the two terminology interchangeably?
Please quote some references (preferably from regulatory bodies), if possible.

Regards,

Kshitij