CFDA and reference scaling [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-08-22 18:59 (2431 d 20:58 ago) – Posting: # 17732
Views: 15,357

Hi Zhang Yong,

❝ On this issue, from my experience with CFDA, they like to adopt US FDA's RSABE guidance.

❝ We have submit such dossier using US FDA's method to CFDA.


That’s interesting given Shuanghe’s post above and followings – which point towards the EMA’s method. Strange.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,987 posts in 4,824 threads, 1,665 registered users;
76 visitors (0 registered, 76 guests [including 4 identified bots]).
Forum time: 15:58 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5