No way! But... [Design Issues]

posted by Beholder  – Russia, 2019-12-06 12:36 (898 d 19:55 ago) – Posting: # 20940
Views: 5,244

(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:

UA Flag
Activity
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 10 (1 registered, 9 guests [including 9 identified bots]).
Forum time: Monday 09:32 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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