Bioequivalence and Bioavailability Forum

46% power in study planning? [Study Assessment]

posted by Helmut – Vienna, Austria, 2013-08-01 15:18 (4707 d 12:38 ago) – Posting: # 11147
Views: 30,981

Hi Sam,

❝ In my study there were five subjects whose data for the test products are not in concurrence to the other subjects data.

Can you please be more specific. What do you mean by “not in concurrence to the other subjects data”?

❝ Should I remove the AUCt parameter only for that subjects which have AUCextrap value more than 20%…

No. You should evaluate the study based on the statistical analysis plan / clinical study protocol. Everything else (post hoc exclusion) is cherry-picking and not acceptable. You can exclude this subjects only in an additional evaluation and present it as a sensitivity analysis.

❝ … write a comment on the report as per our suggestions.

I would try that (i.e., AUC_t is not a reliable/relevant metric of absorption for ER formulations). Back it up with a comparison of half lives.

❝ Since the ratio in the pilot study was around 84% and considering the ISCV of around 26%. The actual sample size come to be around 138.

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% – knowingly running another “casino-type” study? Bad.

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Helmut Schütz

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Science Quotes

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]