Bioequivalence and Bioavailability Forum

Dear all,
As per canadian guidelines, for IR drugs, BE criteria is

1. The 90% confidence interval of the ratio of least squares means for ln-transformed pharmacokinetic parameter AUCT falls with in the acceptance range of 80.00 – 125.00%.
   
2. The ratio of least squares means of test and reference formulation for Cmax on ln-transformed scale should be within 80.00 – 125.00 %.

Now, for sample size calculation, which parameter's intra-subject variability should be considered as 90% CI is only applicable for AUCT only?

Should we consider intra-subject variablity of AUCT parameter only for calculating sample size or we should consider both parameters' intra-subject variability for sample size i.e. Cmax and AUCT as 90% CI criteria is not applicable for Cmax parameter?

Waiting for valuable reply soon.

With regards,

KR