Bioequivalence and Bioavailability Forum • Overpowering

Overpowering [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2013-09-02 14:22 (4672 d 14:53 ago) – Posting: # 11405
Views: 9,026

Hi,
We have conducted two fed studies for a particular molecule, first one was failed.

Study 1 details N=42
Cmax ratio: 117.71 (109.62, 126.40) with CV: 19.56

Study 2 details N=52
Cmax ratio: 106.29 (98.12, 115.15) with CV: 24.64

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.

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%.

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
        
        Overpoweringkumarnaidu 2013-09-02 12:22
        
        Conservative study planning Helmut 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