Bioequivalence and Bioavailability Forum

Hi,
I need clarity in the sample size calculation. My straight question, "what is the maximum expected sample size (for two way crossover design) with the intra subject coefficient of variation of pilot study data around 15%. Kindly clarify.

I have the following data,

Observed Pilot study ISCV% - 12.29%

With the observed pilot study (two way crossover design) ISCV 12.29%, is it possible to expect the 15% ISCV or not for pivotal study design?

What should be the null ratio considerate for the same and under what circumstances we should go for widening of the null ration beyond the 95 - 105% limits or we can in all cases?

During sample size calculation, is there is any restriction to expect the null test/reference ratios in between 95.00 to 105.00% only? I wont feel so.

And also kindly let me know if there is any separate link to access the Diletti et. al. (1991) sample size calculation article.? If available, kindly share the same.

Thanks & Regards,

Balaga Koteswara Rao,
Cadila Pharmaceuticals Ltd,
Ahmedabad, India.