No way! But... [Design Issues]

posted by Beholder  – Russia, 2019-12-06 11:36 (412 d 19:37 ago) – Posting: # 20940
Views: 3,737

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

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
21,310 posts in 4,445 threads, 1,489 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Friday 07:14 UTC (Europe/Vienna)

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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