Confusing [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-03-02 16:37 (1933 d 12:02 ago) – Posting: # 19985
Views: 5,576

Hi John,

❝ Here is the exact wordings from the table (if that makes any difference to what I posted). Note that the summary table also presented +/- Westlake 95% CI..


❝ Cmax(n=24):

❝ Detectable differences(%)=13.28


“Detectable difference” stinks of the FDA’s 80/20 rule (at least 80% post hoc power to detect a 20% difference). Was applied till 1992. IMHO, since 13.28% < 20%, Cmax failed.

❝ T/R Ratio=93.86%

❝ +/- Westlake 95% CI=20.12%


Why 95%? However, Westlake’s CI is an information sink (example). By fiddling around with the t-values his CI is always symmetric around 100%. He suspected that clinicians are not comfortable with a CI which is asymmetric (see this post). As a side effect the T/R-ratio should not be given.

❝ One sided t-test 90% CI:Lower limit= -18.33%, Upper Limit= -6.36%


Here’s the other way ’round. Should be 95%.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
139 visitors (0 registered, 139 guests [including 85 identified bots]).
Forum time: 05:39 CEST (Europe/Vienna)

If you tell the truth you don’t have to remember anything.    Mark Twain

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