Bioequivalence and Bioavailability Forum

Dear HS,

This is a pilot three squence, three period crossover study.

1. Ratio for T2/R is around 98.63% and for T1/R is around 50.00%. I guess Variance is too high Which has affected 90% CI for T2/R to go out of Bioequivalence limit.
2. Calculated sample size for ratio T2/R and Using common variance is too high (more than 100).
3. When I did the analysis by blocking T1 from pharmacokinetic output of WinNonlin ratio of T2/R is around 105.00% and CI fall within bioequivalence limit and intraCV is around 27.99% (calculated from variance).
4. Calculated sample size for ratio T2/R and Using variance (intra CV of 27.99%) is around 33.
5. By blocking T1, ANOVA table shows two degree of freedom for Sequence and Period, since there are 3 Sequence and 3 Period.
6. Is my analysis by blocking T1 is correct?
7. Can I use sample size of 36 if a pivotal study is planned for T2 and R?

Regards,

Atish