Dose normalization [Study Performance]
❝ will not receive the actual dose, but will receive a smaller dose when assessing BD / BE (2x2x2) design)?
I am sorry, but I am a little bit in a hurry and just wanted to start the answers here with one single comment.
As you are in a cross-over situation and assuming that the dose (BSA) of a subject will not change between periods, there is no need for a dose-adjustment with regard to the treatment comparison. Or the other way around: as you compare intraindividually the dose-adjustment would cancel out anyway.