Bioequivalence and Bioavailability Forum • To pool or not to pool

To pool or not to pool [Software]

posted by Helmut – Vienna, Austria, 2014-06-30 23:38 (3948 d 08:37 ago) – Posting: # 13179
Views: 27,479

Hi Zan,

THX for the reference! With one week between groups I would never ever thought a millisecond of setting up a group model. Obviously this was also the approach of the applicant. In Table 9 (page 19) we read:

┌──────────────────────────┬──────────────────────────────────────┐

│ Do you agree or disagree │ Do not agree. Firm analyzed the data │

│ with firm’s decision?    │ as one group, the reviewer analyzed  │

│                          │ data as two separate groups.         │

└──────────────────────────┴──────────────────────────────────────┘

Without knowing the original data I will not comment on the reviewers comments. Do you think that she is aware of “false positives”?

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Helmut Schütz

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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 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 poolHelmut 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