Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Partial AUC [Regulatives / Guidelines]

posted by Vaibhav Patil – India, 2022-07-29 09:20 (1077 d 02:23 ago) – Posting: # 23187
Views: 4,717

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:

Partial AUCVaibhav Patil 2022-07-29 07:20 [Regulatives / Guidelines]
- H[a]VD and MDT Helmut 2022-07-29 11:04
  - Plateau Time in Kazakhstan? mittyri 2022-07-30 14:17
    - Plateau Time in Kazakhstan? Helmut 2022-08-01 18:44
      - EEU changes came into force 11.03.2021 mittyri 2022-08-01 21:24

Admin contact
23,428 posts in 4,929 threads, 1,685 registered users;
40 visitors (0 registered, 40 guests [including 8 identified bots]).
Forum time: 11:43 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