对转换微样本毛细血管血度为血度的方法进行比较评估:帕拉塞他和代谢物作为案例研究
Laura Boffel1, Pieter-Jan De Sutter2, Luc De Baerdemaeker3
1Laboratory of Toxicology, Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, B-9000, Ghent, Belgium.
干毛细血管血液微量采样为患者提供了方便. 这项研究验证了将毛细血管血液结果转换为等效血的方法,表明大多数方法对于药理动力学研究是可靠的.
科学领域:
- 药理动力学和药物新陈代谢
- 分析化学 分析化学
- 临床诊断 临床诊断 临床诊断
背景情况:
- 以患者为中心的抽样,就像干毛细血管血液微抽样一样,正在获得吸引力.
- 一个主要的障碍是将干血结果与已确定的血参考范围相关联.
研究的目的:
- 系统地评估和比较将干毛细血管血度转换为等效血的方法.
- 使用临床药理动力学数据评估这些转化方法的可靠性.
主要方法:
- 收集了55名患者的配对毛细血管体积吸收显微采样 (cVAMS) 和静脉血样本.
- 应用的转换方法:中等毛细血管与血比率,通过巴布洛克回归,线性混合效应建模和血红素 (Hct).
- 根据预先定义的分析和临床接受标准评估性能.
主要成果:
- 大多数转换方法,不包括基于Hct的转换,显示了可接受的分析性能.
- 使用转换cVAMS数据估计的Cmax和AUC6h值满足了大多数分析物和方法的生物等价性标准.
- 基于Hct的转换对于一个分析物来说不那么可靠.
结论:
- 各种方法可靠地将毛细血管血液微抽样结果转换为基于血的等效物.
- 这项研究为未来的微抽样研究提供了一个框架,将其转换为毛细血管血基.
- 这支持了干毛细血管血液微抽样在药理动力学评估中的临床实用性.
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