Potency correction - example [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-06-25 10:10 (857 d 04:42 ago) – Posting: # 18957
Views: 3,717

Dear El Maestro,

» I still can't, after having read up on this for 8 years, see in which way that opportunity does anything good for the sake of the EU patient.
» 90% CI is 77-108 [...]

Now let's take the opposite example: 90% CI is 81-110. Contents: 103% for T, 97% for R. Baseline correction and assay results pre-specified in the protocol. Outcome after correction: the study fails.


Complete thread:

 Admin contact
21,179 posts in 4,414 threads, 1,477 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Thursday 13:53 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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