Bioequivalence and Bioavailability Forum

Dear John,

There are two queries from two different studies;

Situation 1: Situation somewhat similar to yours, where samples were collected up to 36 hrs post dose, but for some of the subjects AUCt could be calculated only up to 8 hrs, for some of the subjects it was up to 16 hrs and for some of the subjects up to 36 hrs.

Query 1: What approach we should implement while comparing such a variable AUCt? Is it a correct method to compare AUC8hrs to AUC36 hrs? Or Is there any other statistical method which we should adopt for such situation?

Situation 2: Samples were collected up to 36 hrs post dose and even achieved zero concentration quite before 36 hrs but still AUC% extrapolation was more than 20 % in many cases (e.g. profile is given in my earlier post)

Query 2: Since extrapolation is more than 20% how do we justify such situation?

I hope I am clear on this occasion.

Best Regards,

Ratnakar