Partial AUC [Regulatives / Guidelines]

posted by Vaibhav Patil – India, 2022-07-29 09:20 (1075 d 14:46 ago) – Posting: # 23187
Views: 4,712

For modifed release formulation (Bioequivalence of partial AUC), refer the article link https://link.springer.com/article/10.1208/s12248-012-9396-8

This elaborates:

[image]


Which part of the curve bioequivalence needs to be established, upper or lower? Is it acceptable approach for EU submission.

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,691 registered users;
52 visitors (0 registered, 52 guests [including 8 identified bots]).
Forum time: 00:06 CEST (Europe/Vienna)

Anyone who conducts an argument by appealing to authority
is not using his intelligence;
he is just using his memory.    Leonardo da Vinci

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