Potency correction - example [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-06-25 12:10 (2188 d 12:36 ago) – Posting: # 18957
Views: 5,603

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
23,059 posts in 4,841 threads, 1,663 registered users;
34 visitors (0 registered, 34 guests [including 8 identified bots]).
Forum time: 00:46 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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