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RegisterBE study in China (for China) [Regulatives / Guidelines]
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.
» 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
All the best,
Shuanghe
Complete thread:
- BE study in China (for China) jag009 2020-06-04 17:50 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study in China (for China)Shuanghe 2020-06-05 10:56
- BE study in China (for China) jag009 2020-06-05 18:41
- BE study in China (for China)Shuanghe 2020-06-05 10:56
Ing. Helmut Schütz