Bioequivalence and Bioavailability Forum

Carved in stone? [Study Assessment]

posted by Helmut – Vienna, Austria, 2013-08-02 05:22 (4301 d 19:28 ago) – Posting: # 11157
Views: 26,061

Hi Sam,

❝ Please suggest some test which we can apply for the exclusion of AUCt parameter for only two subjects.

No idea.

❝ ❝ 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.

Really? If your ratio and CV are just 0.02% (!!) worse, your power would already be <80%. Remember that outcomes of pilot studies are estimates, not set in stone. Planing for 80% power – hoping for exactly matching the pilot and face not a single drop-out in such a large study – is gambling as well.*

In the pivotal study PE ↓ 83.82%, CV ↑ 27%, and you had 14 drop-outs…

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Helmut Schütz

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Complete thread:

AUCextrap more than 20% sam 2013-08-01 06:15 [Study Assessment]
- 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

Carved in stone? [Study As­sess­ment]

Complete thread:

Carved in stone? [Study Assessment]