scale average bioequivalence for parallel design [RSABE / ABEL]

posted by Mahmoud  – Jordan, 2022-06-15 14:33 (900 d 08:59 ago) – Posting: # 23059
Views: 2,797

Dear All
In the following paper

Statistical methodology for highly variable compounds: A novel design approach for the Ofatumumab Phase 2 bioequivalence study

Used scale average bioequivalence for parallel design

Is this method accepted by FDA and EMA

M.Youseef

Edit: Category changed; see also this post #1. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,328 posts in 4,898 threads, 1,660 registered users;
82 visitors (0 registered, 82 guests [including 13 identified bots]).
Forum time: 22:33 CET (Europe/Vienna)

Satisfaction of one’s curiosity is one of the greatest sources
of happiness in life.    Linus Pauling

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