Partial AUC [Regulatives / Guidelines]

posted by Vaibhav Patil – India, 2022-07-29 09:20 (630 d 16:25 ago) – Posting: # 23187
Views: 2,110

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
22,988 posts in 4,825 threads, 1,654 registered users;
94 visitors (0 registered, 94 guests [including 2 identified bots]).
Forum time: 01:45 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