TIE depends on CVwR (and n) [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-02-28 15:48 (1854 d 15:35 ago) – Posting: # 18485
Views: 9,009

Dear Pjs,

❝ […] study is passing the SCABE criteria.

If you are referring to the FDA’s RSABE approach, there is not problem with inflation of the Type I Error if (the true) CVwR ≥30%. Only with CVwR <30% problems might be massive (see this presentation).

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

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

Complete thread:

UA Flag
 Admin contact
22,557 posts in 4,724 threads, 1,607 registered users;
13 visitors (0 registered, 13 guests [including 8 identified bots]).
Forum time: 08:24 CEST (Europe/Vienna)

The function of genius is not to give new answers, but to pose
new questions which time and mediocrity can resolve.    H.R. Trevor-Roper

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