A first look [BE/BA News]

posted by BRB  – Canada, 2022-12-02 19:20 (108 d 06:20 ago) – Posting: # 23379
Views: 2,915

Hi J,
No, it's still there. See lines 260-261:

The number of evaluable subjects in a PK BE study should not be less than 12. For highly variable drug products, a minimum of 24 subjects are recommended for BE assessment.

❝ Almost a complete overhaul. Very detailed. I notice something, they removed the min sample size requirement of n=12 (Unless it's written in later part of the doc)

Complete thread:

UA Flag
 Admin contact
22,546 posts in 4,721 threads, 1,608 registered users;
14 visitors (0 registered, 14 guests [including 8 identified bots]).
Forum time: 01:41 CET (Europe/Vienna)

Science is the great antidote to the poison
of enthusiasm and superstition.    Adam Smith

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