Bioequivalence and Bioavailability Forum • Group Effect in Full Replicate Design

Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2018-09-12 13:20 (2052 d 08:35 ago) – Posting: # 19270
Views: 6,610

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?

EMA: all effects fixed
FDA: all effects fixed except subject(group × sequence) random

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Complete thread:

Group Effect in Full Replicate Design GM 2018-09-12 07:17
- Group Effect in Full Replicate DesignHelmut 2018-09-12 11:20
  - Group Effect in Full Replicate Design GM 2018-09-12 12:32
    - Group Effect in Full Replicate Design Helmut 2018-09-12 13:08
      - Group Effect in Full Replicate Design GM 2018-09-12 13:23
        
        Group Effect in Full Replicate Design Helmut 2018-09-12 15:09
        
        Group Effect in Full Replicate Design GM 2018-09-12 15:19
        
        Group Effect in Full Replicate Design Helmut 2018-09-12 15:31
        
        Group Effect in Replicate Design zizou 2018-09-12 23:30
        
        Group Effect in Replicate Design Helmut 2018-09-13 11:34