Bioequivalence and Bioavailability Forum

dear d_labes!

thank you very much for pointing this out!

Yes it's a one-sample problem where µ0 is a known constant and the data are assumed to be normally distributed. I could imagine that the value of 1.3 is motivated by the normal distribution as approximately 80% of all data fall within -1.3*SD < µ < 1.3*SD.

I think Wellek's liberal suggestions of 0.5 for the standardized effect size for the paired t-test is applicable in this setting. From a regulatory point of view, a justification may be needed for using the scaled ABE approach (using a CI for the standardized effect size or for it's linearized version) in this setting when the CV is smaller than 30%.

For this reason, I would calculate the 90% CI for the ratio µ/µ0 using the corresponding modified Fieller formula and use the widely known confidence interval inclusion approach with margins for ratios for averages relating to 0.5 for the standardized difference (i.e. 0.8 to 1.25) if the CV is smaller than 30%.

what do you think?

best regards

martin

PS.: there were no confidence intervals mentioned in the description of the method