Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-11-23 19:30 CET (UTC+1h)
 

CFDA and reference scaling [Regulatives / Guidelines]

posted by BRB - Canada, 2017-07-20 15:44  - Posting: # 17581
Views: 1,679

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,494 Posts in 3,746 Threads, 1,090 registered users;
26 users online (0 registered, 26 guests).

Cave diving is like playing chess
but the king is not made of wood.    Jochen Hasenmayer

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed