Bioequivalence and Bioavailability Forum

Dear HS,

Many thanks for detailed explanation.
But according to Table 1 “Average Bioequivalence Estimated Numbers of Subjects D=0.05” Results for two-period designs use method of Diletti et al. (Diletti 1991) from FDA’s Statistical Approaches to
Establishing Bioequivalence (page 28 of guidance) Sample size of 2 period with CV of 50 and D=0.05 and power 80% is given as 108 and 75% & 50% of the same is 81 & 54.

and when i check the sample size @ 50% CV, 80% power & GMR 0.95 given in the document article (which i came to know from your previous post) is:
30 & 22 for 3 & 4 period studies respectively according to EMA.
24 & 17 for 3 & 4 period studies respectively according to FDA.

Am why these figures are very different in the guideline, article to the calculation you illustrated.

Thanks in advance.