Partial AUC [Regulatives / Guidelines]

posted by Vaibhav Patil – India, 2022-07-29 07:20 (15 d 06:58 ago) – Posting: # 23187
Views: 432

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
22,301 posts in 4,667 threads, 1,585 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time: Saturday 14:18 CEST (Europe/Vienna)

In the field of observation,
chance favors only the mind that is prepared.    Louis Pasteur

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