A first look [BE/BA News]

posted by BRB  – Canada, 2022-12-02 19:20 (481 d 23:40 ago) – Posting: # 23379
Views: 5,669

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
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
76 visitors (0 registered, 76 guests [including 7 identified bots]).
Forum time: 19:01 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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