Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-09-12 09:20 (811 d 15:38 ago) – Posting: # 19270
Views: 4,560

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
[image]

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

Complete thread:

Activity
 Admin contact
21,226 posts in 4,427 threads, 1,482 registered users;
online 13 (0 registered, 13 guests [including 3 identified bots]).
Forum time: Wednesday 00:58 UTC (Europe/Vienna)

A big data-analyst is an expert
in producing misleading conclusions from huge datasets.
It is much more efficient to use a statistician,
who can do the same with small ones.    Stephen Senn

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