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

posted by Shuanghe  – Spain, 2020-06-05 10:56  – Posting: # 21499
Views: 234

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

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