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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Developmental Pharmacodynamics and Modeling in Pediatric Drug Development
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Developmental Pharmacodynamics and Modeling in Pediatric Drug Development

机译：儿科药物发育的发育药效学与造型

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Challenges in pediatric drug development include small patient numbers, limited outcomes research, ethical barriers, and sparse biosamples. Increasingly, pediatric drug development is focusing on extrapolation: leveraging knowledge about adult disease and drug responses to inform projections of drug and clinical trial performance in pediatric subpopulations. Pharmacokinetic-pharmacodynamic (PK-PD) modeling and extrapolation aim to reduce the numbers of patients and data points needed to establish efficacy. Planning for PK-PD and biomarker studies should begin early in the adult drug development program. Extrapolation relies on the assumption that both the underlying disease and the mechanism of action of the drug used to treat that disease are similar in adults and pediatric subpopulations. Clearly, developmental changes in PK and PD need to be considered to enhance the quality of PK-PD modeling and, therefore, increase the success of extrapolation. This article focuses on the influence of differences in PD between adults and pediatric subpopulations that are highly relevant for the use of extrapolation.
机译：儿科药物开发的挑战包括小患者数量，有限的结果研究，道德障碍和稀疏的生物素。儿科药物开发越来越关注推断：利用有关成人疾病和药物反应的知识，以便在儿科群中提供药物和临床试验表现的预测。药代动力学 - 药效学（PK-PD）建模和推断旨在减少建立疗效所需的患者数量和数据点。 PK-PD和生物标志物研究规划应在成人药物开发计划早期开始。外推依赖于假设潜在疾病和用于治疗这种疾病的药物的作用机制在成人和儿科亚群中类似。显然，PK和PD的发育变化需要考虑提高PK-PD建模的质量，因此增加了外推的成功。本文重点介绍了成人和儿科群之间PD差异对使用外推的差异。

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