The MPRINT Hub Data, Model, Knowledge and Research Coordination Center: Bridging the gap in maternal-pediatric therapeutics research through data integration and pharmacometrics.
The MPRINT Hub Data, Model, Knowledge and Research Coordination Center: Bridging the gap in maternal-pediatric therapeutics research through data integration and pharmacometrics.
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MPRINT Hub 数据、模型、知识和研究协调中心：通过数据集成和药理学缩小母儿治疗研究的差距。
DOI：
10.1002/phar.2765
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发表时间：
2023
期刊：
影响因子：
4.1
通讯作者：
Abbasi,MohammadYaseen
中科院分区：
文献类型：
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作者：
Quinney,SaraK;Bies,RobertR;Grannis,ShaunJ;Bartlett,ChristopherW;Mendonca,Eneida;Rogerson,ColinM;Backes,CarlH;Shah,DhavalK;Tillman,EmmaM;Costantine,MagedM;Aruldhas,BlessedW;Allam,Reva;Grant,Amelia;Abbasi,MohammadYaseen
孕产妇和儿童人群由于其在临床试验中的纳入有限，历来被认为是“治疗孤儿”。妊娠和哺乳期间的生理变化以及儿童的生长和成熟改变药物的药代动力学（PK）和药效学（PD）。在这些人群中进行精确治疗需要了解这些影响。在过去的几十年里，加强孕产妇和儿科参与临床研究的努力有所增加。然而，在这些人群中支持精确治疗的研究往往规模较小，孤立地说，影响可能有限。整合来自各种研究的数据，例如通过基于生理学的药代动力学/药效学（PBPK/PD）建模或生物信息学方法，可以增加来自这些研究的数据的价值，并帮助识别理解上的差距。为了促进孕产妇和儿科精确治疗的研究，尤尼斯·肯尼迪·施里弗国家儿童健康和人类发育研究所（NICHD）的产科和儿科药理学和治疗分支建立了孕产妇和儿科精确治疗（MPRINT）中心。在此，我们概述了母婴治疗学研究的现状，并介绍了印第安纳州大学俄亥俄州州立大学MPRINT Hub数据、模型、知识和研究协调中心（DMKRCC），该中心旨在通过整合和评估现有知识，支持药物计量学和临床试验设计，开发新的真实的世界证据资源，教育计划，并在公共和私人合作伙伴之间建立合作，包括其他NICHD资助的网络。通过促进利用现有数据和资源，DMKRCC将确定知识方面的关键差距，并支持克服这些差距的努力，以加强母婴精确治疗。
Maternal and pediatric populations have historically been considered “therapeutic orphans” due to their limited inclusion in clinical trials. Physiologic changes during pregnancy and lactation and growth and maturation of children alter pharmacokinetics (PK) and pharmacodynamics (PD) of drugs. Precision therapy in these populations requires knowledge of these effects. Efforts to enhance maternal and pediatric participation in clinical studies have increased over the past few decades. However, studies supporting precision therapeutics in these populations are often small and, in isolation, may have limited impact. Integration of data from various studies, for example through physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) modeling or bioinformatics approaches, can augment the value of data from these studies, and help identify gaps in understanding. To catalyze research in maternal and pediatric precision therapeutics, the Obstetric and Pediatric Pharmacology and Therapeutics Branch of theEunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD) established the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub. Herein, we provide an overview of the status of maternal–pediatric therapeutics research and introduce the Indiana University‐Ohio State University MPRINT Hub Data, Model, Knowledge and Research Coordination Center (DMKRCC), which aims to facilitate research in maternal and pediatric precision therapeutics through the integration and assessment of existing knowledge, supporting pharmacometrics and clinical trials design, development of new real‐world evidence resources, educational initiatives, and building collaborations among public and private partners, including other NICHD‐funded networks. By fostering use of existing data and resources, the DMKRCC will identify critical gaps in knowledge and support efforts to overcome these gaps to enhance maternal–pediatric precision therapeutics.