CFDA and reference scaling [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-08-22 18:59 (2435 d 21:17 ago) – Posting: # 17732
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Hi Zhang Yong,

❝ On this issue, from my experience with CFDA, they like to adopt US FDA's RSABE guidance.

❝ We have submit such dossier using US FDA's method to CFDA.


That’s interesting given Shuanghe’s post above and followings – which point towards the EMA’s method. Strange.

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