Bioequivalence and Bioavailability Forum • minimum number of subject in bioequivalence study

minimum number of subject in bioequivalence study [Power / Sample Size]

posted by khaoula – Algeria, 2014-09-27 13:14 (4283 d 02:14 ago) – Posting: # 13600
Views: 22,025

Hi everybody,

I have two questions:

Why the minimum simple size fixed by all regulatory authorities is 12? because when we consult the table of Sample Size for Schuirmann’s Two One-Sided t-Tests Procedure, we note that for low CV <15% the number of subject required is < 12?
in pilot study, we need small simple size, but could it be greater than 12?

thank you

Complete thread:

minimum number of subject in bioequivalence studykhaoula 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 GLs Helmut 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

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