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

posted by Helmut Homepage – Vienna, Austria, 2018-02-28 14:48 (1333 d 12:42 ago) – Posting: # 18485
Views: 8,488

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 🖖
Helmut Schütz

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

Complete thread:

 Admin contact
21,753 posts in 4,548 threads, 1,544 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Sunday 04:30 CEST (Europe/Vienna)

They were “so intent of making everything numerical”
that they frequently missed seeing
what was there to be seen.    Barbara McClintock

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