CFDA and reference scaling [Regulatives / Guidelines]
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
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 Shuanghe 2017-07-21 18:09
- CFDA and reference scaling BRB 2017-07-20 22:33
- 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
- CFDA and reference scaling Shuanghe 2017-08-29 13:12
- CFDA and reference scaling Helmut 2017-08-22 16:59
- CFDA and reference scaling Helmut 2017-07-20 22:09