Bioequivalence and Bioavailability Forum • To pool or not to pool

To pool or not to pool [Software]

posted by Helmut – Vienna, Austria, 2014-07-01 00:22 (4371 d 01:04 ago) – Posting: # 13182
Views: 31,140

Hi Zan,

❝ Was it due to significant effect observed for Group x Treatment that resulted in the reviewer's decision to run final analysis by separate groups (on Page 5)?

Sure. The text contains a reference:

In control #98-392 (see attachment), it is stated that “if the Group-by-Treatment interaction is statistically significant (p<0.1), DBE requested that equivalence be demonstrated in one of the groups, provided that the group meets minimum requirements for a complete bioequivalence study”.

However, #98-392 is not attached. I failed to dig it out at the FDA (controlled correspondence not covered by FOI?). Note the wording almost identical to my post above.

Please no more TOFU in future posts. THX.

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Complete thread:

Phoenix WNL to handle 2x2 crossover study with multip group zan 2014-06-27 23:29 [Software]
- 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 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 poolHelmut 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