Bioequivalence and Bioavailability Forum

Dear All,

I have done a study four years back, in two groups in a gap of only two days between the dosing due to the capacity constraints of the CPU, the study is passing but group effect was not tested that time. Now a query from one of the regulatory has come to test for the group effect.

We have done the group effect by introducing Treatment*Group effect in the ANOVA model and we are getting significant p value only for Cmax and but for AUC the p value is above 0.05.

Now my question is if we combine the data from both the group (consider it as one group) the study is passing and even after adding the treatment*group effect as one the variable then also study is passing (CI for Cmax and AUC are with in limits of 80-125%) but significant difference is found for Cmax (p-value is 0.0172)


Now in this situation can we combine the results of two group and if not what is the way out? Your valuable comments on this will be highly appriciated.

Thanking you in advance!

Ratnakar