Bioequivalence and Bioavailability Forum • Reported 99.98%, correct 1.4%

Reported 99.98%, correct 1.4% [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2015-02-23 18:38 (4133 d 05:16 ago) – Posting: # 14491
Views: 17,801

Hi Monica,

❝ I'm sorry if I didn't get it correctly, but this is what I mean […]

Excuse my French, but this synopsis is crap. The CV for free ezetimibe’s AUC_0-t is 20.5% (assuming 25/24 subjects in the sequences). Bloody irrelevant post hoc power is ~1.4% – not 99.98%!

Try:

library(PowerTOST) lower <- 0.7295 upper <- 0.8372 n <- 49 GMR <- sqrt(lower*upper) CV <- CI2CV(lower=lower, upper=upper, n=n) cat(" CV =", round(CV*100, 1), "%\n", "Power =", round(power.TOST(CV=CV, theta0=GMR, n=n)*100, 1), "%\n")

BTW, do you think that it makes sense to report the AUC with eight significant digits?

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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 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