Dose normalization [Study Per­for­mance]

posted by Relaxation  – Germany, 2021-05-27 17:29 (1405 d 10:06 ago) – Posting: # 22373
Views: 3,254

❝ 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!

Complete thread:

UA Flag
Activity
 Admin contact
23,411 posts in 4,922 threads, 1,665 registered users;
34 visitors (0 registered, 34 guests [including 8 identified bots]).
Forum time: 03:35 CEST (Europe/Vienna)

Statistic – A subject which most statisticians find difficult
but in which nearly all physicians are expert.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5