Bioequivalence and Bioavailability Forum • Group effect in 2x2 BE study

Group effect in 2x2 BE study [Software]

posted by ElMaestro – Denmark, 2014-06-30 22:36 (4356 d 23:01 ago) – Posting: # 13176
Views: 30,877

Hi Zan,

❝ Thanks very much for the useful reply, ElMaestro and Helmut! Yes I am using Phoenix Winnonlin to work on this analysis. If there is a significant treatment*Group effect, is the overall (all subject) ratio (CI90%) still valid, or we have to adopt the ratio (CI90%) from separate groups?

I personally find it very difficult to address a significant group x treatment interaction. To help visual interpretation you could plot the four effects in a bar diagram. A low p-value for group x treatment means you think the four bars all not of equal height. Where does that leave us?
ABE is all about the treatment performance in itself and not treatment in summer versus treatment in winter (the latter just to make it a little extreme, hope you get the general idea). Sure, if there is a pronounced difference in stability of T and R, respectively, and the two groups are well separated in time then we could observe group x treatment, but this is speculation and besides if such stability differences would exist they should be caught and handled well before any study is kicked off cf. GMP and GCP.
I am inclined to say a significant group x treatment should be considered a mere nuisance just like Conchita Wurst or nail fungus.

—
Pass or fail!
ElMaestro

Complete thread:

Phoenix WNL to handle 2x2 crossover study with multip group zan 2014-06-27 23:29
- Phoenix WNL to handle 2x2 crossover study with multip group ElMaestro 2014-06-28 23:23
- Group effect commonly not relevant Helmut 2014-06-30 16:55
  - Group effect in 2x2 BE study zan 2014-06-30 19:18
    - Group effect in 2x2 BE studyElMaestro 2014-06-30 20:36
    - To pool or not to pool Helmut 2014-06-30 20:51
      - To pool or not to pool zan 2014-06-30 21:02
        
        To pool or not to pool Helmut 2014-06-30 21:38
        
        To pool or not to pool zan 2014-06-30 21:46
        
        To pool or not to pool Helmut 2014-06-30 22:22
        
        To pool or not to pool zan 2014-07-01 01:15
        
        Partial vs. sequential tests in WNL Helmut 2014-07-01 12:26
        
        Partial vs. sequential tests in WNL zan 2014-07-01 18:03
        
        Loosing patience Helmut 2014-07-01 18:23
        
        To pool or not to pool ElMaestro 2014-06-30 22:11
        
        To pool or not to pool zan 2014-07-01 01:18
        To pool or not to pool zan 2014-07-02 19:56
        
        To pool or not to pool ElMaestro 2014-07-03 00:17
        
        To pool or not to pool zan 2014-07-03 00:36
        
        sequence- / period effect #666 Helmut 2014-07-03 10:05
  - Group effect commonly not relevant AngusMcLean 2014-07-06 16:19
    - Group effect commonly not relevant Helmut 2014-07-06 20:32
      - Group effect commonly not relevant AngusMcLean 2014-07-06 22:52
        
        Group effect commonly not relevant Helmut 2014-07-06 23:57
        
        PHX: Parameter mapping AngusMcLean 2014-07-07 15:04
        
        PHX: Parameter mapping Helmut 2014-07-07 15:45
        
        PHX: Parameter mapping Shuanghe 2014-07-07 17:35
        
        Great hint! Helmut 2014-07-07 17:54
        PHX: Parameter mapping AngusMcLean 2014-07-07 20:49
        
        PHX: Parameter mapping AngusMcLean 2014-07-07 18:46