Full-replicate design in two groups [General Sta­tis­tics]

posted by Mikalai  – Belarus, 2018-10-31 14:04 (693 d 09:54 ago) – Posting: # 19510
Views: 1,734

Dear all,
We are conducting a full replicate design study. Due to recruiting difficulties we had to split the study in two groups. It has been suggested that we should change our statistical model to model II of FDA. What risks, if any, carry on this model to our bioequivalence? Can additional factors in model artificially reduce our CV and push us out of the scaled approach to usual 125%-80% one (I am not a statistician, so my question may be statistically correct)? Should we change our usual 4-factor model?

Complete thread:

Activity
 Admin contact
21,072 posts in 4,394 threads, 1,468 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Thursday 00:58 CEST (Europe/Vienna)

Enlightenment is man’s emergence from his self-imposed nonage
for which he himself was responsible.
Nonage is the inability to use one’s own intellect
without the direction of another.    Immanuel Kant

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