Safe and Effective Variability-A Criterion for Dose Individualization
Safe and Effective Variability-A Criterion for Dose Individualization
复制标题
DOI：
10.1097/ftd.0b013e31826aabc3
复制
发表时间：
2012-10-01
影响因子：
2.5
通讯作者：
Buclin, Thierry
中科院分区：
文献类型：
--
作者：
Holford, Nicholas H. G.;Buclin, Thierry
背景资料：临床药理学的一个主要目标是了解决定剂量-效应关系的因素，并利用这些知识来个体化药物dose.Methods：A principle based criteria is proposed for deciding among alternative individualization methods.Results：Safe and effective variability定义了药物浓度在群体平均值附近的最大可接受群体变异性。通过比较特定给药方法后的剩余群体变异性与安全有效变异性，可以决定单独的患者协变量是否足够，或者是否需要治疗药物监测联合靶浓度干预。
Background: A primary goal of clinical pharmacology is to understand the factors that determine the dose-effect relationship and to use this knowledge to individualize drug dose.Methods: A principle-based criterion is proposed for deciding among alternative individualization methods.Results: Safe and effective variability defines the maximum acceptable population variability in drug concentration around the population average.Conclusions: A decision on whether patient covariates alone are sufficient, or whether therapeutic drug monitoring in combination with target concentration intervention is needed, can be made by comparing the remaining population variability after a particular dosing method with the safe and effective variability.