Potency correction - example [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-06-25 10:10 (1504 d 16:10 ago) – Posting: # 18957
Views: 4,682

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:

UA Flag
 Admin contact
22,288 posts in 4,665 threads, 1,583 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Monday 02:20 CEST (Europe/Vienna)

Don’t compromise yourself.
You are all you’ve got.    Janis Joplin

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