Potency correction - example [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-06-25 12:10 (2501 d 05:32 ago) – Posting: # 18957
Views: 6,392

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.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,668 registered users;
14 visitors (0 registered, 14 guests [including 6 identified bots]).
Forum time: 17:43 CEST (Europe/Vienna)

Garbage in, garbage out.
It’s very very simple.    Anders Fuglsang

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