No way! But... [Design Issues]

posted by ElMaestro  – Denmark, 2019-12-06 13:14 (680 d 17:59 ago) – Posting: # 20941
Views: 4,685

Hello, both,

» » At this situation, should this subject's data with one period be included in the BE assessment?
»
» No, you could not.

We do not need a T-R comparison in each subject to do an analysis. We are just stuck in that paradigm. We could in principle fit a model with missing period data. And all data could be used for the calculation of the CI.
I do not know why there is a regulatory tradition for only using completers - I would say there is even a potential scientific and ethical advantage of using all period data.

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,729 posts in 4,543 threads, 1,543 registered users;
online 16 (0 registered, 16 guests [including 3 identified bots]).
Forum time: Sunday 08:13 CEST (Europe/Vienna)

Be very, very careful what you put into that head,
because you will never, ever get it out.    Thomas Wolsey

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