No way! But... [Design Issues]

posted by ElMaestro  – Denmark, 2019-12-06 14:14 (2033 d 12:19 ago) – Posting: # 20941
Views: 9,647

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:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,681 registered users;
42 visitors (0 registered, 42 guests [including 12 identified bots]).
Forum time: 03:33 CEST (Europe/Vienna)

Fools with Tools Are Still Fools!    Anonymous

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