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

Group effect in 2x2 BE study [Software]

posted by zan – US, 2014-06-30 21:18 (3948 d 11:56 ago) – Posting: # 13175
Views: 27,238

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?

Regarding FDA's requirement below (equivalence be demonstrated in one of the groups), do we have a link to the source of the letter? I am hoping to keep it as a reference for study files.

❝ If the Treatment-by-Group term is not significant (p ≥0.1) this term can be dropped from the model, proceeding to Group Model II.

❝ If the Treatment-by-Group term is significant (p <0.1), FDA’s Division of Bioequivalence requests that equivalence be demonstrated in one of the groups, provided that the group meets minimum requirements for a complete BE study (i.e., 12).

Best regards
zan

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 studyzan 2014-06-30 19:18
    - Group effect in 2x2 BE study ElMaestro 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