Bioequivalence and Bioavailability Forum • “Overpowered” studies due to GLs

“Overpowered” studies due to GLs [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2014-09-29 05:51 (4279 d 11:03 ago) – Posting: # 13612
Views: 19,947

Hi Khaoula,

❝ […] so 12 subjects it's a sure way to have "sufficient" and large power, if perhaps CV of the study is larger than planed (for small values of CV), the number of subject will be sufficient to prove bioequivalence

Correct. On the other hand it will allow to show BE with a PE far away from 100%. With a CV of 6% in 12 subjects we will still have 70% power to demonstrate BE with a PE of 84.7%… I don’t comment on whether this is a good idea.
Regulators move in mysterious ways.

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Complete thread:

minimum number of subject in bioequivalence study khaoula 2014-09-27 11:14
- minimum number of subject in bioequivalence study ElMaestro 2014-09-27 11:26
  - minimum number of subject in bioequivalence study khaoula 2014-09-27 23:49
    - “Overpowered” studies due to GLs Helmut 2014-09-28 01:13
      - “Overpowered” studies due to GLs khaoula 2014-09-28 22:36
        
        “Overpowered” studies due to GLsHelmut 2014-09-29 03:51
      - Scientific Validation for the Sample Size Formula mreyes 2014-11-07 19:47
        
        Basic maths Helmut 2014-11-07 20:09
        
        Basic maths mreyes 2014-11-07 20:47
        
        Reference for CI ⇒ MSE Helmut 2014-12-14 01:51
        
        Reference for CI ⇒ MSE mreyes 2015-02-19 19:50
        
        Failed study: power <80%! Helmut 2015-02-20 19:09
        
        Failed study: power <80%! mreyes 2015-02-23 17:07
        
        Reported 99.98%, correct 1.4% Helmut 2015-02-23 17:38
        
        Reported 99.98%, correct 1.4% ElMaestro 2015-02-23 17:51
        
        GMR ∉ AR ⇒ power <5% Helmut 2015-02-24 01:33
        
        GMR ∉ AR ⇒ power <5% mreyes 2015-02-24 17:34