jag009
★★★

NJ,
2020-06-04 15:50
(141 d 17:12 ago)

Posting: # 21498
Views: 899
 

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

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
Shuanghe
★★  

Spain,
2020-06-05 08:56
(141 d 00:06 ago)

@ jag009
Posting: # 21499
Views: 524
 

 BE study in China (for China)

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
jag009
★★★

NJ,
2020-06-05 16:41
(140 d 16:21 ago)

@ Shuanghe
Posting: # 21500
Views: 509
 

 BE study in China (for China)

Hi,

» 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.

Thank you. Of course I wont use too small a sample size...
J
Activity
 Admin contact
21,179 posts in 4,414 threads, 1,475 registered users;
online 10 (0 registered, 10 guests [including 3 identified bots]).
Forum time: Saturday 09:02 UTC (Europe/Vienna)

It is the peculiar and perpetual error of the human understanding
to be more moved and excited by affirmatives than negatives.    Francis Bacon

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