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Back to the forum  2018-06-22 19:34 CEST (UTC+2h)

CFDA and reference scaling [Regulatives / Guidelines]

posted by BRB - Canada, 2017-07-20 15:44  - Posting: # 17581
Views: 4,384

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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