Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-10-19 20:14 CEST (UTC+2h)
 

CFDA and reference scaling [Regulatives / Guidelines]

posted by BRB - Canada, 2017-07-20 15:44  - Posting: # 17581
Views: 1,402

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
17,395 Posts in 3,726 Threads, 1,073 registered users;
31 users online (0 registered, 31 guests).

No investigation can strictly be called scientific
unless it admits of mathematical demonstration.    Leonardo da Vinci

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