Real-World Data for Pediatric Pharmacometrics: Can We Upcycle Clinical Data for Research Use?
作者信息
Van Driest Sara L, Choi Leena
机构信息
Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
出版信息
Clin Pharmacol Ther. 2019 Jul;106(1):84-86. doi: 10.1002/cpt.1416. Epub 2019 Apr 3.
Abstract
摘要
相似文献
1
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.
2
Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model-Informed Drug Development in Oncology.研讨会会议记录：美国食品药品监督管理局 - 国际药代动力学学会肿瘤学模型指导药物研发
Clin Pharmacol Ther. 2019 Jul;106(1):81-83. doi: 10.1002/cpt.1421. Epub 2019 Apr 5.
3
A Call for Objective Dose Selection to Increase Success in Pediatric Clinical Trials: A Perspective From NICHD and NIMH Program Staff.呼吁进行客观剂量选择以提高儿科临床试验成功率：来自美国国立儿童健康与人类发展研究所和美国国立精神卫生研究所项目工作人员的观点
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S9-S12. doi: 10.1002/jcph.1849.
4
Model-Informed Pediatric Drug Development: Application of Pharmacometrics to Define the Right Dose for Children.模型指导下的儿科药物研发：药物代谢动力学在确定儿童适宜剂量中的应用。
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S52-S59. doi: 10.1002/jcph.1841.
5
Progress in Drug Development-Pediatric Dose Selection: Workshop Summary.药物研发进展-儿科剂量选择：研讨会总结。
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S13-S21. doi: 10.1002/jcph.1828.
6
Status Toward the Implementation of Precision Dosing in Children.儿童精准用药实施现状。
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S36-S51. doi: 10.1002/jcph.1830.
7
The European Medicines Agency Experience With Pediatric Dose Selection.欧洲药品管理局在儿科剂量选择方面的经验。
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S22-S27. doi: 10.1002/jcph.1863.
8
Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012-2020.2012-2020 年向美国 FDA 提交的药物开发计划中儿科剂量选择方法。
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S28-S35. doi: 10.1002/jcph.1853.
9
Neonatal and Pediatric Dose Selection: Quo Vadis?新生儿和儿科剂量选择：何去何从？
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S7-S8. doi: 10.1002/jcph.1888.
10
Real-World Data: An Unrealized Opportunity in Global Health?真实世界数据：全球健康领域中未被实现的机遇？
Clin Pharmacol Ther. 2019 Jul;106(1):57-59. doi: 10.1002/cpt.1476. Epub 2019 Jun 12.
引用本文的文献
1
Characterizing Enoxaparin's Population Pharmacokinetics to Guide Dose Individualization in the Pediatric Population.表征依诺肝素的群体药代动力学以指导儿科人群的个体化剂量。
Clin Pharmacokinet. 2024 Jul;63(7):999-1014. doi: 10.1007/s40262-024-01388-x. Epub 2024 Jul 2.
2
Model-based approach to identify predictors of paclitaxel-induced myelosuppression in "real-world" administration.基于模型的方法来识别“真实世界”给药中紫杉醇引起的骨髓抑制的预测因子。
CPT Pharmacometrics Syst Pharmacol. 2023 Jul;12(7):929-940. doi: 10.1002/psp4.12963. Epub 2023 Apr 26.
3
An introduction to causal inference for pharmacometricians.《药物计量学家因果推断入门》
CPT Pharmacometrics Syst Pharmacol. 2023 Jan;12(1):27-40. doi: 10.1002/psp4.12894. Epub 2022 Dec 8.
4
Off-Label, but on-Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy.超适应证用药，但有证据支持？儿科药物治疗的证据水平评价综述。
Clin Pharmacol Ther. 2022 Dec;112(6):1243-1253. doi: 10.1002/cpt.2736. Epub 2022 Sep 25.
5
The Blind Spot of Pharmacology: A Scoping Review of Drug Metabolism in Prematurely Born Children.药理学的盲点：对早产儿药物代谢的范围综述
Front Pharmacol. 2022 Feb 15;13:828010. doi: 10.3389/fphar.2022.828010. eCollection 2022.
6
Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology.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。
Clin Pharmacol Ther. 2020 Apr;107(4):707-709. doi: 10.1002/cpt.1763. Epub 2020 Jan 26.
7
Development of a System for Postmarketing Population Pharmacokinetic and Pharmacodynamic Studies Using Real-World Data From Electronic Health Records.利用电子健康记录中的真实世界数据开发上市后人群药代动力学和药效学研究系统。
Clin Pharmacol Ther. 2020 Apr;107(4):934-943. doi: 10.1002/cpt.1787. Epub 2020 Feb 11.
8
medExtractR: A targeted, customizable approach to medication extraction from electronic health records.medExtractR：一种从电子健康记录中提取药物信息的针对性、可定制方法。
J Am Med Inform Assoc. 2020 Mar 1;27(3):407-418. doi: 10.1093/jamia/ocz207.
9
Electronic Health Record-Embedded Decision Support Platform for Morphine Precision Dosing in Neonates.电子健康记录嵌入式决策支持平台，用于新生儿吗啡精准给药。
Clin Pharmacol Ther. 2020 Jan;107(1):186-194. doi: 10.1002/cpt.1684. Epub 2019 Dec 11.
10
Gene-Based Dose Optimization in Children.基于基因的儿童剂量优化。
Annu Rev Pharmacol Toxicol. 2020 Jan 6;60:311-331. doi: 10.1146/annurev-pharmtox-010919-023459. Epub 2019 Jul 5.
本文引用的文献
1
Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality.利用真实世界证据（RWE）的力量：确保监管级数据质量的检查表。
Clin Pharmacol Ther. 2018 Feb;103(2):202-205. doi: 10.1002/cpt.946. Epub 2017 Dec 6.
2
Clinical Pharmacology Studies in Critically Ill Children.危重症儿童的临床药理学研究
Pharm Res. 2017 Jan;34(1):7-24. doi: 10.1007/s11095-016-2033-y. Epub 2016 Sep 1.
3
Making sense of big data in health research: Towards an EU action plan.理解健康研究中的大数据：迈向欧盟行动计划。
Genome Med. 2016 Jun 23;8(1):71. doi: 10.1186/s13073-016-0323-y.
4
Pragmatic pharmacology: population pharmacokinetic analysis of fentanyl using remnant samples from children after cardiac surgery.实用药理学：利用心脏手术后儿童的残留样本对芬太尼进行群体药代动力学分析。
Br J Clin Pharmacol. 2016 Jun;81(6):1165-74. doi: 10.1111/bcp.12903. Epub 2016 Apr 15.
5
Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?结合多个医疗保健数据库进行药品和疫苗上市后安全性监测：为什么以及如何进行？
J Intern Med. 2014 Jun;275(6):551-61. doi: 10.1111/joim.12159.
Zotero 插件