Bioequivalence and Bioavailability Forum • Scientific Validation for the Sample Size Formula

Scientific Validation for the Sample Size Formula [Power / Sample Size]

posted by mreyes – México, 2014-11-07 20:47 (3825 d 03:13 ago) – Posting: # 13843
Views: 17,511

Dear Helmut and everybody! Sorry if I posted my question on the wrong place (first time posting on this forum). I used the formula presented on slides 25-26 (link below) on a clinical protocol as justification for sample size calculation and the mexican regulatory agency asked for a scientific justification or a bibliography where the robustness of the formula can be proved/demosntrated. Do you have the specific reference of this? Thanks in advance, regards

Monica

❝ See this presentation (slide 9)

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 GLs Helmut 2014-09-29 03:51
      - Scientific Validation for the Sample Size Formulamreyes 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