缺失的时钟时间的归算 - 适用于出生后的前素度时间课程
Abigail J Bokor1, Nick Holford1, Jacqueline A Hannam2
1Department of Pharmacology and Clinical Pharmacology, The University of Auckland, 85 Park Road, Grafton, Auckland, 1023, New Zealand.
Journal of pharmacokinetics and pharmacodynamics
|March 19, 2025
概括
准确的生物标志物分析需要精确的样本时间. 这项研究开发并验证了一种用于归因缺失样本时钟时间的方法,提高了对新生儿中的prokalcitonin等生物标志物的人口建模精度.
科学领域:
- 制药指标 (Pharmacometrics) 是一个指标.
- 生物标记分析 生物标记分析
- 人口建模的人口建模
背景情况:
- 生物标志物时间过程通常以相对于事件的日数报告,缺乏具体的样本时间.
- 由于潜在的快速每日波动,这种遗漏限制了生物标志物的实用性,特别是对于急性阶段蛋白质,如prokalcitonin.
- 准确的时间数据对于了解临床环境中的生物标志物动态至关重要,例如新生儿护理.
研究的目的:
- 调查和比较用于在生物标志物数据中赋予缺失样本时钟时间的策略.
- 利用新生儿中的prokalcitonin度作为开发和评估归算方法的模型系统.
- 建立一个可靠的方法来选择最佳的时间归算策略,用于人口建模.
主要方法:
- 利用了来自282名新生儿的1275个普卡尔西托尼度,可用日期但缺少样本时间 (场景0).
- 使用三个不同的场景假定缺失时钟时间:最小采样间隔,生物标志物度趋势和标准医院采样实践.
- 使用非线性混合效应 (NLME) 与每个归算场景的NONMEM模拟的公素,通过客观函数值 (OFV) 和视觉预测检查来评估性能.
主要成果:
- 基于标准医院采样实践的归算策略 (情景3) 产生了最佳表现,与0.0情景相比,显著改善了客观函数值 (∆OFV: -62.6).
- 与其他归算情景相比,情景3导致出生和前激素增加之间的预计延迟时间更短 (平均:12.0小时).
- 视觉预测检查支持场景3作为捕获procalcitonin动态的最准确的归算方法.
结论:
- 标准的医院采样实践为在生物标志物研究中归因缺失的样本时钟时间提供了可靠的基础.
- 精确的时钟计算提高了人口模型的精度,从而更好地描述了生物标志物动力学.
- 开发的方法为解决各种生物医学研究环境中缺少的时间数据提供了一个框架.
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