model-based BE? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-12-10 11:13 (176 d 13:50 ago) – Posting: # 23397
Views: 3,270

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
22,616 posts in 4,740 threads, 1,613 registered users;
14 visitors (0 registered, 14 guests [including 9 identified bots]).
Forum time: 02:03 CEST (Europe/Vienna)

Mediocrity is a fungus of the mind.    Reif Larsen

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