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

posted by Shuanghe  – Spain, 2020-06-05 10:56 (114 d 14:03 ago) – Posting: # 21499
Views: 500

Hi John,

» 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.
In the old guidance 18 to 24 subjects were mentioned so I guess that many people considered 18 as minimum number.

There is no minimum size requirement by the new guidance. It only mentions that statistical power should be ensured by the sample size. See link of guidances in that post.
—
All the best,
Shuanghe

Complete thread:

Activity
 Admin contact
21,079 posts in 4,396 threads, 1,468 registered users;
online 2 (0 registered, 2 guests [including 1 identified bots]).
Forum time: Monday 00:59 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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