儿童剂量估算的建模方法。
Modelling approaches to dose estimation in children.
作者信息
Johnson Trevor N
机构信息
Simcyp Ltd, Blades Enterprise Centre, John Street, Sheffield S2 4SU, UK.
出版信息
Br J Clin Pharmacol. 2005 Jun;59(6):663-9. doi: 10.1111/j.1365-2125.2005.02429.x.
Abstract
Most of the drugs on the market are originally developed for adults and dosage selection is based on an optimal balance between clinical efficacy and safety. The aphorism 'children are not small adults' not only holds true for the selection of suitable drugs and dosages for use in children but also their susceptibility to adverse drug reactions. Since children may not be subject to dose escalation studies similar to those carried out in the adult population, some initial estimation of dose in paediatrics should be obtained via extrapolation approaches. However, following such an exercise, well-conducted PK-PD or PK studies will still be needed to determine the most appropriate doses for neonates, infants, children and adolescents.
摘要
市场上的大多数药物最初是为成年人开发的，剂量选择基于临床疗效和安全性之间的最佳平衡。“儿童不是小大人”这句格言不仅适用于为儿童选择合适的药物和剂量，也适用于他们对药物不良反应的易感性。由于儿童可能无法像成人那样进行剂量递增研究，因此儿科剂量的一些初步估计应通过外推法获得。然而，在进行这样的操作之后，仍然需要进行良好的药代动力学-药效学（PK-PD）或药代动力学（PK）研究，以确定新生儿、婴儿、儿童和青少年的最合适剂量。
相似文献
1
Modelling approaches to dose estimation in children.儿童剂量估算的建模方法。
Br J Clin Pharmacol. 2005 Jun;59(6):663-9. doi: 10.1111/j.1365-2125.2005.02429.x.
2
Modeling and simulation in pediatric drug therapy: Application of pharmacometrics to define the right dose for children.儿科药物治疗中的建模与模拟：药物代谢动力学在确定儿童正确剂量中的应用。
Clin Pharmacol Ther. 2015 Sep;98(3):298-308. doi: 10.1002/cpt.169. Epub 2015 Jul 20.
3
Population approaches in paediatrics.儿科学中的群体方法。
Fundam Clin Pharmacol. 2008 Dec;22(6):575-8. doi: 10.1111/j.1472-8206.2008.00647.x.
4
Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling.儿童定制药物治疗：创建数据共享和群体药代动力学-药效学建模的基础设施
Drug Discov Today. 2009 Mar;14(5-6):316-20. doi: 10.1016/j.drudis.2008.11.004. Epub 2008 Dec 26.
5
Delivery of inhaled drugs for infants and small children: a commentary on present and future needs.婴儿和幼儿吸入药物的传递：对当前和未来需求的评论。
Clin Ther. 2012 Nov;34(11):S36-45. doi: 10.1016/j.clinthera.2012.10.004.
6
Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.定量临床药理学在儿科药物批准和标签中的作用。
Drug Metab Dispos. 2016 Jul;44(7):924-33. doi: 10.1124/dmd.116.069559. Epub 2016 Apr 14.
7
A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development.儿科药物研发中的新生儿药代动力学和药效学研究综述。
Clin Pharmacol Ther. 2015 Sep;98(3):328-35. doi: 10.1002/cpt.149.
8
Individualizing the use of medications in children: making Goldilocks happy.个体化儿童用药：让 Goldilocks 满意。
Clin Pharmacol Ther. 2014 Sep;96(3):304-6. doi: 10.1038/clpt.2014.130. Epub 2014 Jun 13.
9
Optimizing pediatric dosing: a developmental pharmacologic approach.优化儿科用药剂量：一种发育药理学方法。
Pharmacotherapy. 2009 Jun;29(6):680-90. doi: 10.1592/phco.29.6.680.
10
Drug therapy in childhood: what has been done and what has to be done?儿童药物治疗：已经做了什么以及还需要做什么？
Pediatr Pharmacol (New York). 1983;3(3-4):131-43.
引用本文的文献
1
Precision Dosing Management with Intelligent Computing in Digital Health.数字健康中基于智能计算的精准剂量管理
Proc Int Conf Intell Netw Collab Syst. 2020 Aug-Sep;1263:269-280. doi: 10.1007/978-3-030-57796-4_26. Epub 2020 Aug 21.
2
Performance of the allometric power model in scaling from adult to paediatric antiretroviral dose in children at a Referral Hospital in Windhoek, Namibia.在纳米比亚温得和克的一家转诊医院，从成人到儿科抗逆转录病毒剂量的比例幂模型在儿童中的表现。
Afr Health Sci. 2022 Sep;22(3):436-441. doi: 10.4314/ahs.v22i3.47.
3
Amikacin Therapy in Japanese Pediatric Patients: Narrative Review.阿米卡星治疗日本儿科患者：叙事性综述。
Int J Environ Res Public Health. 2022 Feb 10;19(4):1972. doi: 10.3390/ijerph19041972.
4
Health Functionalities of Betaine in Patients With Homocystinuria.甜菜碱在同型胱氨酸尿症患者中的健康功能
Front Nutr. 2021 Sep 9;8:690359. doi: 10.3389/fnut.2021.690359. eCollection 2021.
5
Implementation of a Physiologically Based Pharmacokinetic Modeling Approach to Guide Optimal Dosing Regimens for Imatinib and Potential Drug Interactions in Paediatrics.实施基于生理的药代动力学建模方法以指导伊马替尼的最佳给药方案及儿科潜在药物相互作用
Front Pharmacol. 2020 Jan 30;10:1672. doi: 10.3389/fphar.2019.01672. eCollection 2019.
6
Estimation of an Appropriate Dose of Trazodone for Pediatric Insomnia and the Potential for a Trazodone-Atomoxetine Interaction.估算曲唑酮治疗儿童失眠的适宜剂量及曲唑酮-托莫西汀相互作用的可能性。
CPT Pharmacometrics Syst Pharmacol. 2020 Feb;9(2):77-86. doi: 10.1002/psp4.12480. Epub 2020 Jan 11.
7
Patient-specific dosimetry of Tc-HYNIC-Tyr-Octreotide in children.儿童患者特异性的Tc-HYNIC-酪氨酰-奥曲肽剂量测定法
EJNMMI Phys. 2017 Oct 13;4(1):24. doi: 10.1186/s40658-017-0191-6.
8
First dose in neonates: are juvenile mice, adults and in vitro-in silico data predictive of neonatal pharmacokinetics of fluconazole.新生儿的首剂给药：幼年小鼠、成年动物及体外-计算机模拟数据能否预测氟康唑的新生儿药代动力学？
Clin Pharmacokinet. 2014 Nov;53(11):1005-18. doi: 10.1007/s40262-014-0169-7.
9
Changes in individual drug-independent system parameters during virtual paediatric pharmacokinetic trials: introducing time-varying physiology into a paediatric PBPK model.虚拟儿科药代动力学试验中个体药物非依赖性系统参数的变化：将时变生理学引入儿科 PBPK 模型。
AAPS J. 2014 May;16(3):568-76. doi: 10.1208/s12248-014-9592-9. Epub 2014 Apr 4.
10
Clinical trials in children.儿童临床试验。
Br J Clin Pharmacol. 2015 Mar;79(3):357-69. doi: 10.1111/bcp.12305.
本文引用的文献
1
Developmental pharmacokinetics and pharmacodynamics of nizatidine.尼扎替丁的发育药代动力学和药效学
J Pediatr Gastroenterol Nutr. 2004 Apr;38(4):442-51. doi: 10.1097/00005176-200404000-00015.
2
Physiologically based pharmacokinetic (PBPK) modeling of caffeine and theophylline in neonates and adults: implications for assessing children's risks from environmental agents.新生儿和成人中咖啡因和茶碱基于生理的药代动力学（PBPK）建模：对评估儿童环境暴露风险的启示
J Toxicol Environ Health A. 2004 Feb 27;67(4):297-329. doi: 10.1080/15287390490273550.
3
Modeling interindividual variation in physiological factors used in PBPK models of humans.模拟人体生理药代动力学（PBPK）模型中所使用生理因素的个体间差异。
Crit Rev Toxicol. 2003;33(5):469-503.
4
The development of drug metabolising enzymes and their influence on the susceptibility to adverse drug reactions in children.儿童药物代谢酶的发育及其对药物不良反应易感性的影响。
Toxicology. 2003 Oct 1;192(1):37-48. doi: 10.1016/s0300-483x(03)00249-x.
5
Inter-individual variability in levels of human microsomal protein and hepatocellularity per gram of liver.每克肝脏中人类微粒体蛋白水平和肝细胞数量的个体间变异性。
Br J Clin Pharmacol. 2003 Oct;56(4):433-40. doi: 10.1046/j.1365-2125.2003.01881.x.
6
Evaluation of the potential impact of pharmacokinetic differences on tissue dosimetry in offspring during pregnancy and lactation.孕期和哺乳期药代动力学差异对后代组织剂量测定潜在影响的评估。
Regul Toxicol Pharmacol. 2003 Aug;38(1):1-16. doi: 10.1016/s0273-2300(03)00047-3.
7
Target-controlled infusion of rocuronium in infants, children, and adults: a comparison of the pharmacokinetic and pharmacodynamic relationship.婴幼儿、儿童及成人中罗库溴铵的靶控输注：药代动力学与药效学关系的比较
Anesth Analg. 2003 Jul;97(1):44-9, table of contents. doi: 10.1213/01.ane.0000066262.32103.60.
8
Physiological modeling of age-specific changes in the pharmacokinetics of organic chemicals in children.儿童有机化学品药代动力学年龄特异性变化的生理模型。
J Toxicol Environ Health A. 2003 Mar 14;66(5):417-33. doi: 10.1080/15287390306450.
9
10
Ontogeny of hepatic and renal systemic clearance pathways in infants: part I.婴儿肝脏和肾脏全身清除途径的个体发生：第一部分。
Clin Pharmacokinet. 2002;41(12):959-98. doi: 10.2165/00003088-200241120-00003.
Zotero 插件