Model‐Informed Drug Development: Steps Toward Harmonized Guidance

Scott Marshall, Malidi Ahamadi, Jenny Chien, Daisuke Iwata, Pavel Farkas, Augusto Filipe, Nicolas Frey, Erin Greene, Norisuke Kawai, Jian Li, Jörg Lippert, Flora Musuamba Tshinanu, Efthymios Manolis, Mark C. Peterson, Sarem Sarem, Mohamad Shebley, Million Tegenge, Chia‐Hsun Tsai, Chien‐Lung Tu, Yasuto Otsubo, Jiawei Wei, Lucia Zhang, Hao Zhu, Kristin E. Karlsson

doi:10.1002/cpt.3006

書誌事項

タイトル別名

Steps Toward Harmonized Guidance

説明

Global alignment of expectations is required to achieve consistency in the planning, conduct, reporting, and regulatory review of modelinformed drug development (MIDD) applications. An International Council for Harmonization (ICH) MIDD general principles guideline has been positioned to provide a common standard of practice including a framework for risk-based assessment of MIDD-derived evidence within the context of global regulatory decision-making. This perspective provides the background, our viewpoints, and the next steps in the development of this guideline.

収録刊行物

Clinical Pharmacology & Therapeutics

Clinical Pharmacology & Therapeutics 114 954-959, 2023-08-03

Wiley

詳細情報詳細情報について

CRID: 1874242817253263744

DOI: 10.1002/cpt.3006

ISSN: 15326535; 00099236

PubMed: 37534711

データソース種別

OpenAIRE

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