Dose normalization [Study Per­for­mance]

posted by Relaxation  – Germany, 2021-05-27 17:29 (617 d 20:21 ago) – Posting: # 22373
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❝ will not receive the actual dose, but will receive a smaller dose when assessing BD / BE (2x2x2) design)?


Hello yura.

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.

Best regards!

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