Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-09-12 11:20 (896 d 16:13 ago) – Posting: # 19270
Views: 4,720

Hi Gm,

» […] BE study of Highly variable drug in […] 3 groups, which are seperated by one month from each other. There is no clarity in the guidance to check the group effect for this design.

Which agency’s guidance?

» Our doubt is, whether the group effect should be checked in the full replicate design or not?

What do you mean by “checked”? Have group – together with some nested terms – as part of the model (only report the MSEs, p-values) or do you additionally want to base any decision on it? That’s not a good idea, since power might be compromised and the Type I Error inflated (see this presentation).

» If so, what are the fixed/random effets need to be checked in RSABE and ABE?

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,355 posts in 4,458 threads, 1,493 registered users;
online 14 (0 registered, 14 guests [including 3 identified bots]).
Forum time: Thursday 02:33 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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