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Applications of Model Informed Drug Development (MIDD) in Drug Development Lifecycle and Regulatory Review.

作者信息

Mitra Amitava, Wang Yaning

机构信息

Clinical Pharmacology and Pharmacometrics, Janssen R&D, Spring House, PA, USA.

Clinical Pharmacology, Kura Oncology, San Diego, CA, USA.

出版信息

Pharm Res. 2022 Aug;39(8):1663-1667. doi: 10.1007/s11095-022-03327-6. Epub 2022 Jul 5.

DOI:10.1007/s11095-022-03327-6
PMID:35790617
Abstract
摘要

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The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives.
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