Bioequivalence and Bioavailability Forum

AUCextrap more than 20% [Study Assessment]

posted by ElMaestro – Denmark, 2013-08-01 12:29 (4717 d 14:18 ago) – Posting: # 11139
Views: 31,110

Hi Sam,

❝ (...) the study fails marginally in lower CI in AUCt that is 79.28. The failure in this study is due to the presence of two outlier in the whole study. If we remove these outliers the study qualify the BE criteria for all the three parameters. But as we all know that USFDA don’t encourage the outliers test and its exclusion from the study (...) So please suggest if we can do in same line as I am thinking or there are any other ways to save our study.

If you can for-cause audit the study and ID justifiable reasons for exclusion of the subjects in question then that would most likely be ok (pukey-pukey in period 1 but not in period 2 and stuff like that). But it takes real effort to do it, and the audit should not just focus on the values/subjects that you believe caused study failure but also on the subjects that were in your views within the normal range.

A little off topic, but given the recent discuss in another thread, this example is one where the concept of a repeat trial may become relevant. If your lower CI limit was 79.28% then chances are that the true T/R (geometric mean, observed) was likely to be reasonably close to 100% and that more subjects in the trial therefore would have saved it. Got some numbers for us?

—
Pass or fail!
ElMaestro

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

AUCextrap more than 20% [Study As­sess­ment]

Complete thread:

AUCextrap more than 20% [Study Assessment]