Bioequivalence and Bioavailability Forum

Reference for CI ⇒ MSE [Power / Sample Size]

posted by Helmut  – Vienna, Austria, 2014-12-14 02:51 (4215 d 21:15 ago) – Posting: # 14070
Views: 19,533

Hi Monica,

❝ […] 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.

Detlew Labes implemented my formulas in the R package PowerTOST, function CI2CV(). With this little code

library(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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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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