Use of 96.7% CI instead of 90% CI [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2015-07-08 19:29 (3547 d 18:15 ago) – Posting: # 15054
Views: 3,468

Hi pjs,

❝ What could be the reason to use 96.7% CI (decreasing the patient risk ??? increasing the faith in product???)


❝ and what justification would have been given.


I have no actual idea, but I think some kind of multiplicity issue could have been the case here since they worked with a decreased alpha. Perhaps it was something with a semi-sequential design, multiple candidate formulations and/or interim picking of a final one for finalisation, or something along those lines?

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,409 posts in 4,921 threads, 1,709 registered users;
29 visitors (0 registered, 29 guests [including 5 identified bots]).
Forum time: 12:45 CET (Europe/Vienna)

It’s easy to lie with statistics;
it is easier to lie without them.    Frederick Mosteller

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