Bioequivalence and Bioavailability Forum

Dear Helmut,

We conducted a 2-way crossover BE study for CANADA. But it has failed on upper side (135% for Cmax, 130% for AUCt) and Power is 90% and 95% for Cmax & AUCt respectively.

Now we are going to conduct a Add-on study for this. As per CANADIAN Guidance

If BE is not shown, additional subjects are included.

1) If an F-test (equality of variances) shows no significance, we can go for a pooled analysis.

Does it means (F-Test)

F=Mean Square Error (from ANOVA) of Cmax for Study1 / Mean Square Error of Cmax for Study2 Should be insignificant?

In the same way for AUCt.

Plz let me know the above is correct or not.