model-based BE? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-12-10 11:13 (942 d 19:55 ago) – Posting: # 23397
Views: 13,163

Hi Mittyri,

❝ FDA encourages generic and new drug applicants to propose and discuss novel methodologies (e.g., model-based BE…)


❝ are you reading this as a projection of VBE or some broader successful trends exist?


Perhaps. See this post refering to the EMA’s Methodology Working Party. Aren’t these points contradictory?

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
23,428 posts in 4,929 threads, 1,684 registered users;
64 visitors (0 registered, 64 guests [including 22 identified bots]).
Forum time: 08:08 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

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