BE study in China (for China) [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-06-04 17:50 (117 d 08:54 ago) – Posting: # 21498
Views: 870

Hi,

Does anyone know if there is a min sample size requirement for a pivotal (submission) BE study for regulatory submission in China? In US I believe it's n=12 (unless changed), not sure about China.

Thanks
J

Complete thread:

Activity
 Admin contact
21,086 posts in 4,398 threads, 1,468 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Wednesday 02:44 CEST (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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