No way! But... [Design Issues]

posted by Beholder  – Russia, 2019-12-06 12:36  – Posting: # 20940
Views: 952

(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
Beholder

Complete thread:

Activity
 Admin contact
20,237 posts in 4,258 threads, 1,396 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 11:06 CET

Science may set limits to knowledge,
but should not set limits to imagination.    Bertrand Russell

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5