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

posted by Helmut Homepage – Vienna, Austria, 2018-02-28 15:48 (2270 d 15:38 ago) – Posting: # 18485
Views: 9,632

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
23,029 posts in 4,834 threads, 1,641 registered users;
28 visitors (0 registered, 28 guests [including 8 identified bots]).
Forum time: 08:26 CEST (Europe/Vienna)

The most erroneous stories are those we think we know best–
and therefore never scrutinize or question.    Stephen Jay Gould

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