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Back to the forum  Query: 2017-12-12 22:51 CET (UTC+1h)
 

CFDA and reference scaling [Regulatives / Guidelines]

posted by BRB - Canada, 2017-07-20 15:44  - Posting: # 17581
Views: 1,918

Hello all,

To anyone's knowledge does the CFDA allow for FDA or EMA reference scaling? I tried looking into the current Chinese regulatory documents:

http://www.sfda.gov.cn/WS01/CL1751/147583.html

but I could not find anything which mentions it, particularly in Annex 3 which seems to focus on the PK and stats analysis.

If anyone can provide some guidance, it would be appreciated.
Thank you!
BRB

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