Bioequivalence and Bioavailability Forum

Hi SW°

❝ i put AUC and Cmax value of those subjects into winnonlin, and executed BE test. but there is no intra CV% value in result table... (T/R ratio and all kinds of CI interval was calculated)

WinNonlin (up to to the recent version Phoenix/WinNonlin 6.3) includes Intrasubject CV in the standard output only for 2×2 cross-over designs.

❝ 1. how can i get intra subj CV%?

For any higher-order design (like your 6×3) you have to calculate it from the residual variance Var(Residual). In Phoenix use a data transformation and in ‘classical’ WinNonlin (up to 5.3) write the formula directly in a cell of the result table:

CV=sqrt(exp(Var(Residual))-1))

❝ 2. In my case, 6x3 crossover is appropriate design?

Yes, why not? I have learned that a 3×3 Latin Square is sufficient as well.

❝ 3. If I perform winnonlin BE test separately, (first performance is for R and T1, and the next one is for R and T2) is it OK?

In PHX/WNL that’s the only way to run the analysis. It depends on what is stated in the protocol whether you use a multiplicity correction. I would use it. The most conservative for two simultaneous tests is Bonferroni (i.e., 95% confidence intervals) – but there are other (slightly more powerful) methods on the market as well.