No way! But... [Design Issues]

posted by Beholder  – Russia, 2019-12-06 12:36 (499 d 00:47 ago) – Posting: # 20940
Views: 3,980

(edited by Beholder on 2019-12-06 13:06)

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:

 Admin contact
21,419 posts in 4,475 threads, 1,509 registered users;
online 8 (0 registered, 8 guests [including 2 identified bots]).
Forum time: Sunday 14:23 CEST (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

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