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用于儿科临床药理学的个体发生知识基础的科学和监管考虑因素。

Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology.

机构信息

Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Obstetric and Pediatric Pharmacology and Therapeutics Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.

出版信息

Clin Pharmacol Ther. 2020 Apr;107(4):707-709. doi: 10.1002/cpt.1763. Epub 2020 Jan 26.

DOI:10.1002/cpt.1763
PMID:31983072
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7875197/
Abstract

Understanding all aspects of developmental biology, or pediatric ontogeny, that affect drug therapy from the fetus to the adolescent child is the holy grail of pediatric scientists and clinical pharmacologists. The scientific community is now close to being able to tie together the vast amount of information collected on pediatric ontogeny over the past 60 years. An organized knowledge base and new tools would allow us to utilize this information effectively in pediatric drug development.

摘要

了解从胎儿到青春期儿童的药物治疗受影响的发育生物学或儿科个体发生的所有方面,是儿科科学家和临床药理学家的圣杯。科学界现在已经接近于能够将过去 60 年来收集的大量关于儿科个体发生的信息联系在一起。一个有组织的知识库和新工具将使我们能够在儿科药物开发中有效地利用这些信息。

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本文引用的文献

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Incorporating Ontogeny in Physiologically Based Pharmacokinetic Modeling to Improve Pediatric Drug Development: What We Know About Developmental Changes in Membrane Transporters.将个体发育纳入生理基于药代动力学模型,以改善儿科药物开发:我们对膜转运体发育变化的了解。
J Clin Pharmacol. 2019 Sep;59 Suppl 1(Suppl 1):S56-S69. doi: 10.1002/jcph.1489.
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Pediatric Ontogeny: Moving From Translational Science to Drug Development.儿科个体发育:从转化科学迈向药物研发
J Clin Pharmacol. 2019 Sep;59 Suppl 1:S7-S8. doi: 10.1002/jcph.1481.
3
Predictive Pediatric Modeling and Simulation Using Ontogeny Information.基于个体发育信息的儿科预测建模与仿真。
J Clin Pharmacol. 2019 Sep;59 Suppl 1:S95-S103. doi: 10.1002/jcph.1497.
4
Pediatric Renal Ontogeny and Applications in Drug Development.小儿肾脏发育及其在药物开发中的应用。
J Clin Pharmacol. 2019 Sep;59 Suppl 1:S9-S20. doi: 10.1002/jcph.1490.
5
Real-World Data for Pediatric Pharmacometrics: Can We Upcycle Clinical Data for Research Use?儿科药物计量学的真实世界数据:我们能否将临床数据升级用于研究?
Clin Pharmacol Ther. 2019 Jul;106(1):84-86. doi: 10.1002/cpt.1416. Epub 2019 Apr 3.
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A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration.抗精神病药和抗抑郁药向美国食品和药物管理局提交的儿科和成人安全性研究比较。
J Pediatr. 2019 May;208:236-242.e3. doi: 10.1016/j.jpeds.2018.12.033. Epub 2019 Jan 21.
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Clin Pharmacol Ther. 2018 Mar;103(3):376-378. doi: 10.1002/cpt.1001. Epub 2018 Jan 31.
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ADMETNet: The knowledge base of pharmacokinetics and toxicology network.ADMETNet:药代动力学与毒理学网络知识库。
J Genet Genomics. 2017 May 20;44(5):273-276. doi: 10.1016/j.jgg.2017.04.005. Epub 2017 May 3.
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