Multi-group studies ad nauseam [BE/BA News]

posted by Achievwin – US, 2023-02-25 17:18 (99 d 08:25 ago) – Posting: # 23475
Views: 1,280

The FDA? Where?


Outlined in FDAs Statistical approaches for BE studies guidance in lines 516-544 clearly stats do your analysis on complete population (not to split hair on groups :-D ). My experience group effect is critical when heterogenous ethnic population across multiple continents are recruited and contributing to disproportional variability and results skewing the final outcome.

Hope it churns more academic discussion and we MAY have some clarity before I retire.....:-D:-D:-D

Complete thread:

UA Flag
Activity
 Admin contact
22,616 posts in 4,740 threads, 1,613 registered users;
26 visitors (0 registered, 26 guests [including 13 identified bots]).
Forum time: 02:44 CEST (Europe/Vienna)

Mediocrity is a fungus of the mind.    Reif Larsen

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