Bioequivalence and Bioavailability Forum • Conservative study planning

Conservative study planning [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-09-02 14:42 (4685 d 09:28 ago) – Posting: # 11406
Views: 9,135

Hi Kumar,

❝ We have conducted two fed studies for a particular molecule,…

More important: same formulation?

❝ From earlier published studies we found that they have conducted the study for N=30 subjects with CV: 33 and the study was passed but they are not talking about the power of the study.

“Power of the study” is meaningless. It might be that they planned for a larger deviation of test from reference and lower CV than what was later observed in the study. In order words, the study passed more or less by chance (i.e., with a higher producer’s risk).

❝ Now we want to conduct another study for the same molecule then should we go with the study 2 conducted by us or with the literature with high CV of 33%.

I would suggest to base study planning on your own results (you have little information from the literature about side conditions which have an impact on the variability: food, posture, analytical method, …). I would also suggest to be conservative and use the upper confidence limit of the CV, which for the second study is 29.7%.

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Complete thread:

Sample size vasup 2013-07-29 08:37 [Regulatives / Guidelines]
- Sample size ElMaestro 2013-07-29 10:00
- Sample size jag009 2013-07-29 15:57
- Overpowering Helmut 2013-07-30 15:51
  - Overpowering ElMaestro 2013-07-30 16:37
    - Overpowering jag009 2013-07-30 16:45
      - Overpowering ElMaestro 2013-07-30 16:51
        
        Overpowering jag009 2013-08-01 20:08
        
        Overpowering kumarnaidu 2013-09-02 12:22
        
        Conservative study planningHelmut 2013-09-02 12:42
        
        Conservative study planning kumarnaidu 2013-09-02 14:36
        
        Conservative study planning Ohlbe 2013-09-02 18:44
        
        confidence limit of the CV Jay 2013-09-06 13:55
        
        CL of CV Helmut 2013-09-06 15:02
        
        CL of CV Jay 2013-09-06 15:21
        
        CL of CV Helmut 2013-09-06 15:42
        
        PE consideration Jay 2013-09-11 11:02
        
        PE consideration Dr_Dan 2013-09-11 12:07
        
        PE consideration Jay 2013-09-11 13:09
        PE consideration kumarnaidu 2013-09-11 13:22
        
        Sockpuppet? Helmut 2013-09-11 14:13
        PE consideration kumarnaidu 2013-09-12 13:04