History lessons - FDA BE 90% CI [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-02-26 15:19 (782 d 19:32 ago) – Posting: # 19976
Views: 4,168

Thanks guys!

» @John: The 90% CI was recommended in 1992.7

Thanks Helmut. The reason I asked is because I read some report (dated 1990; the synopsis only) and the one sided 90% CI was reported as lower = -18.33%, upper = -6.36%; T/R Ratio = 93.86, n=24. I found it strange to report CI in such a way so I was wondering if the reporting was based on some old rules.

Thanks
J

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 24 (0 registered, 24 guests [including 2 identified bots]).
Forum time: Monday 11:52 CEST (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

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