准确剂量定量的人口药动力学模型的外部评估和选择指南
Mehdi El Hassani1,2, Amélie Marsot3,4
1Faculté de Pharmacie, Université de Montréal, 2940 Chemin de Polytechnique, Montréal, QC, H3T 1J4, Canada. mehdi.el.hassani@umontreal.ca.
Clinical pharmacokinetics
|December 4, 2025
概括
这项研究提供了一个框架,用于评估和选择基于模型的精确剂量定量的人口药理学模型. 它旨在通过标准化这些模型的评估和实施来改善这些模型的临床应用.
科学领域:
- 制药指标 (Pharmacometrics) 是一个指标.
- 临床药理学 临床药理学
- 药物开发 药物开发
背景情况:
- 基于模型的精确剂量 (MIPD) 使用人口药理动力学 (PPK) 模型来个性化药物治疗.
- 尽管公布了众多的PPK模型,但由于缺乏标准化指导,很少有人接受外部评估或临床实施.
研究的目的:
- 为公布的PPK模型的外部评估和选择提供一个结构化的框架.
- 促进PPK模型在MIPD的临床实践中被采用.
主要方法:
- 该框架详细说明了定义模型使用,评估数据集,选候选模型和应用诊断的步骤.
- 它解决了模型评估中的方法论和实践挑战.
主要成果:
- 提出了一种系统方法,用于评估现有的PPK模型是否适合于新的临床应用.
- 该指南促进在现实环境中可重复使用模型.
结论:
- 标准化评估对于弥合PPK模型开发和临床应用之间的差距至关重要.
- 该框架通过提高所选择模型的可靠性来支持MIPD的有效实施.
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