Bioequivalence and Bioavailability Forum • Conservative study planning

Conservative study planning [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2013-09-02 16:36 (4672 d 09:57 ago) – Posting: # 11408
Views: 8,939

Thanks Helmut,
The formulation is same.
One more thing I want to ask, by using mean ratio: 1.05, CV: 0.297 and power: 0.8 I am getting sample size of around 40. But as we know we failed to prove bioequivalent in our first study with sample size of 42 subjects then should we remain stick to 40 or some more research needed in this. Also earlier studies for the same formulation by others is showing that 30 to 40 is enough. Please guide me.

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 planning Helmut 2013-09-02 12:42
        
        Conservative study planningkumarnaidu 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