Bioequivalence and Bioavailability Forum • CFDA and reference scaling

CFDA and reference scaling [Regulatives / Guidelines]

posted by BRB – Canada, 2017-07-20 17:44 (2465 d 04:12 ago) – Posting: # 17581
Views: 16,877

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

Complete thread:

CFDA and reference scalingBRB 2017-07-20 15:44 [Regulatives / Guidelines]
- CFDA and reference scaling Helmut 2017-07-20 22:09
  - CFDA and reference scaling BRB 2017-07-20 22:33
    - CFDA and reference scaling Shuanghe 2017-07-21 18:09
      - OT: Uplading / attaching files Helmut 2017-07-21 18:25
    - CFDA: seemingly like the EMA Helmut 2017-07-21 19:23
      - CFDA: seemingly like the EMA Shuanghe 2017-07-24 18:47
- CFDA and reference scaling yicaoting 2017-08-22 16:49
  - CFDA and reference scaling Helmut 2017-08-22 16:59
    - CFDA and reference scaling Shuanghe 2017-08-29 13:12
      - CFDA and reference scaling yicaoting 2017-08-29 18:51