Bioequivalence and Bioavailability Forum

46% power in study planning? [Study Assessment]

posted by jag009 – NJ, 2013-08-01 22:04 (4301 d 12:39 ago) – Posting: # 11151
Views: 25,833

❝ ❝ Can you elaborate? With T/R of 84% and a CV of 26% you would have needed 342 (!) subjects to obtain 80% power (and still 260 for 70% power – which is the lowest any serious IEC should accept, IMHO). Was your target power only 46% – running another “casino-type” study? Bad.

❝

❝ I Really apologize for the mistake, the ratio is 84.71 and CV for the pilot study is 19.11.

With ISCV=19.11, T/R ratio 84.71, n~140 at 80% power so you were within range with your pivotal study.

If outlier test confirms then one option is to do a rechallenge study -> Run another small study with the questionable subjects along with a few controls.

I assume you tweaked the formulation based on the pilot study data (Ratio 84.71) before going pivotal? Going into a pivotal study with the same formulation is a bit risky IMHO...

John

Complete thread:

AUCextrap more than 20% sam 2013-08-01 06:15
- AUCextrap more than 20% ElMaestro 2013-08-01 10:29
  - AUCextrap more than 20% sam 2013-08-01 11:21
    - AUCextrap more than 20% ElMaestro 2013-08-01 11:39
      - AUCextrap more than 20% sam 2013-08-01 12:01
        
        AUCextrap more than 20% Helmut 2013-08-01 12:52
    - forced BE d_labes 2013-08-01 11:59
      - Gambling ♠ ♣ ♥ ♦ Helmut 2013-08-01 13:31
- AUCextrap more than 20% Helmut 2013-08-01 12:32
  - AUCextrap more than 20% sam 2013-08-01 12:55
    - 46% power in study planning? Helmut 2013-08-01 13:18
      - 46% power in study planning? sam 2013-08-01 13:40
        
        46% power in study planning?jag009 2013-08-01 20:04
        
        Re-dosing Helmut 2013-08-02 03:32
        
        Re-dosing jag009 2013-08-02 05:10
        
        Re-dosing Helmut 2013-08-02 14:44
        
        46% power in study planning? sam 2013-08-02 07:00
        
        Carved in stone? Helmut 2013-08-02 03:22
        
        Carved in stone? sam 2013-08-02 07:02
        
        Carved in stone? luvblooms 2013-08-02 08:37
        
        Carved in stone? sam 2013-08-02 09:01
        
        Ethics (again) Helmut 2013-08-02 14:53
        
        Update jag009 2013-08-02 17:25
        
        Update Helmut 2013-08-02 18:11
        
        Update jag009 2013-08-02 20:11
        
        Outliers (CAN) Helmut 2013-08-02 20:56
        
        Outliers (CAN) jag009 2013-08-02 22:23
        
        OT: Expert Helmut 2013-08-03 10:11
        
        Update jag009 2013-08-02 22:29
        
        Update ElMaestro 2013-08-02 23:08
        
        Update jag009 2013-08-03 23:00
        
        Update luvblooms 2013-08-05 06:02
        
        Update jag009 2013-08-05 20:14

46% power in study planning? [Study As­sess­ment]

Complete thread:

46% power in study planning? [Study Assessment]