Bioequivalence and Bioavailability Forum

Hi all,

may I add that while adjustment for BW seems a nogo in 'ordinary' BE discplines, it is quite the opposite for biosimilars where you more often than not (said solely on basis of the biosimilars I am working on) add BW as a covariate in the model. I don't think it was entirely clear what type of product was behind the question in this case.

At any rate, regardless of whether BW is taken into account one way or another, all this should be established at the time of protocol drafting. If the idea to adjust by BW was a result of a failing BE study then, naturally, the prospects may not be good.