No way! But... [Design Issues]

posted by Beholder  – Russia, 2019-12-06 13:36 (1600 d 15:22 ago) – Posting: # 20940
Views: 6,077

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
22,993 posts in 4,828 threads, 1,657 registered users;
63 visitors (0 registered, 63 guests [including 10 identified bots]).
Forum time: 05:59 CEST (Europe/Vienna)

So far as I can remember,
there is not one word in the Gospels
in praise of intelligence.    Bertrand Russell

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