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Enhancing inclusivity in clinical trials: Model-informed drug development for pregnant individuals in the era of personalized medicine.

作者信息

Dallmann André, Bonate Peter L, Burnham Janelle, George Blessy, Yao Lynne, Knöchel Jane

机构信息

Bayer HealthCare SAS, Lille, France, on behalf of: Pharmacometrics/Modeling & Simulation, Research & Development, Pharmaceuticals, Bayer AG, Leverkusen, Germany.

Early Development, New Technologies Group, Astellas, Northbrook, Illinois, USA.

出版信息

CPT Pharmacometrics Syst Pharmacol. 2024 Nov;13(11):1824-1829. doi: 10.1002/psp4.13218. Epub 2024 Aug 18.

DOI:10.1002/psp4.13218
PMID:39155562
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11578124/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e01/11578124/6b59e4aa62ba/PSP4-13-1824-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e01/11578124/6b59e4aa62ba/PSP4-13-1824-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e01/11578124/6b59e4aa62ba/PSP4-13-1824-g001.jpg

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Front Med (Lausanne). 2023 Nov 29;10:1241456. doi: 10.3389/fmed.2023.1241456. eCollection 2023.
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Deriving mechanism-based pharmacodynamic models by reducing quantitative systems pharmacology models: An application to warfarin.通过简化定量系统药理学模型来推导演化药理学模型：以华法林为例。
CPT Pharmacometrics Syst Pharmacol. 2023 Apr;12(4):432-443. doi: 10.1002/psp4.12903. Epub 2023 Mar 3.
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A review of pregnancy and lactation postmarketing studies required by the FDA.
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Maternal-Fetal Drug Development: An Industry Perspective.母体-胎儿药物研发：行业视角。
J Clin Pharmacol. 2022 Sep;62 Suppl 1(Suppl 1):S18-S29. doi: 10.1002/jcph.2124.
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Translational Systems Pharmacology Studies in Pregnant Women.孕妇转化系统药理学研究。
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