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

posted by Shuanghe  – Spain, 2020-06-05 12:56 (1393 d 04:42 ago) – Posting: # 21499
Views: 1,024

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
111 visitors (0 registered, 111 guests [including 4 identified bots]).
Forum time: 16:38 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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