Bioequivalence and Bioavailability Forum • Sample size

Sample size [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-07-29 17:57 (4712 d 09:17 ago) – Posting: # 11112
Views: 9,284

Hi,

❝ Can any one clarify on "is there any regulatory guidance or barrier to use the more number of subjects than required". For example based on the calculation and to get required power 50 subjects are sufficient what will be fate of the study if i use 100 subjects. Is acceptable to regulatory agencies.

You can have a larger sample size than the number suggested by the power calculation to compensate for potential dropouts due to length of the study and potential adverse events. However, you can't go too large a number.

100 subjects vs 50 subjects is a BAD example...

John

Complete thread:

Sample size vasup 2013-07-29 08:37
- Sample size ElMaestro 2013-07-29 10:00
- Sample sizejag009 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 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