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Partial AUC [Regulatives / Guidelines]

posted by Vaibhav Patil – India, 2022-07-29 09:20 (191 d 20:09 ago) – Posting: # 23187
Views: 1,144

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

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