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Paving the Path for Increased Technological Innovation, Strategic Decision Making and Regulatory Acceptance of Modeling and Simulation Approaches.

作者信息

Fang Lanyan, Tsakalozou Eleftheria, Polli James E

机构信息

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Department of Pharmaceutical Sciences, University of Maryland, Baltimore, MD, USA.

出版信息

Pharm Res. 2025 May;42(5):727-729. doi: 10.1007/s11095-025-03868-6.

DOI:10.1007/s11095-025-03868-6
PMID:40437346
Abstract
摘要

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Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program.
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