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

posted by jag009  – NJ, 2020-06-04 17:50 (510 d 12:24 ago) – Posting: # 21498
Views: 1,196

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

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