Partial AUC [Regulatives / Guidelines]

posted by Vaibhav Patil – India, 2022-07-29 09:20 (578 d 06:18 ago) – Posting: # 23187
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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:

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

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