Reference for CI ⇒ MSE [Power / Sample Size]
❝ […] 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?
Nothing about robustness yet, but by chance I found a reference* in my files “[…] how to retrieve residual intrasubject mean squared error from historical summary results in the literature.”

Given in the Examples 2–4: 90% CI 0.83–1.15, N 30
- paired design; calculated intrasubject MSE 0.1381.
- 2×2 crossover; calculated intrasubject MSE 0.1378.
- 6×3 Williams’ design; calculated intrasubject MSE 0.1425.
PowerTOST
, function CI2CV()
. With this little codelibrary(PowerTOST)
LL <- 0.83
UL <- 1.15
N <- 30
des <- c("paired", "2x2x2", "3x6x3")
for (j in seq_along(des)) {
cat(sprintf("%6s design: intrasubject MSE %.4f%s", des[j],
CV2mse(CI2CV(lower=LL, upper=UL, n=N, design=des[j],
alpha=0.05)), "\n"))
}
I got…
paired design: intrasubject MSE 0.1381
2x2x2 design: intrasubject MSE 0.1378
3x6x3 design: intrasubject MSE 0.1425
… matching results of the reference. ✔
Hope it’s not too late for the authority…
- Yuan J, Tong T, Tang M-L. Sample Size Calculation for Bioequivalence Studies Assessing Drug Effect and Food Effect at the Same Time With a 3-Treatment Williams Design. Ther Innov Regul Sci. 2013;47(2):242–7. doi:10.1177/2168479012474273.
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Helmut Schütz
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Science Quotes
Complete thread:
- minimum number of subject in bioequivalence study khaoula 2014-09-27 11:14 [Power / Sample Size]
- 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 ⇒ MSEHelmut 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
- GMR ∉ AR ⇒ power <5% Helmut 2015-02-24 01:33
- Reported 99.98%, correct 1.4% ElMaestro 2015-02-23 17:51
- Reported 99.98%, correct 1.4% Helmut 2015-02-23 17:38
- Failed study: power <80%! mreyes 2015-02-23 17:07
- Failed study: power <80%! Helmut 2015-02-20 19:09
- Reference for CI ⇒ MSE mreyes 2015-02-19 19:50
- Basic maths Helmut 2014-11-07 20:09
- “Overpowered” studies due to GLs khaoula 2014-09-28 22:36
- “Overpowered” studies due to GLs Helmut 2014-09-28 01:13
- minimum number of subject in bioequivalence study khaoula 2014-09-27 23:49
- minimum number of subject in bioequivalence study ElMaestro 2014-09-27 11:26