No way! But... [Design Issues]

posted by Beholder  – Russia, 2019-12-06 13:36 (1152 d 16:46 ago) – Posting: # 20940
Views: 5,448

Dear ssussu!

❝ At this situation, should this subject's data with one period be included in the BE assessment?

No, you could not.

❝ Why?

Because you need comparison between T and R for each subject. This is the aim - to compare. In your case you have either T or R (I dont know exactly which drug was taken on period 2). At least, you could use Cmax value from period 2 if the subject withdraw after Cmax was reached. AUC - no way.

Best regards

Complete thread:

UA Flag
 Admin contact
22,477 posts in 4,708 threads, 1,603 registered users;
17 visitors (0 registered, 17 guests [including 8 identified bots]).
Forum time: 06:23 CET (Europe/Vienna)

I think it is much more interesting to live with uncertainty
than to live with answers that might be wrong.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz