Clinical feasibility of dried blood spots: Analytics, validation, and applications

被引：117

作者：

Enderle, Yeliz ^{[1
]}

Foerster, Kathrin ^{[1
]}

Burhenne, Juergen ^{[1
]}

机构：

[1] Univ Heidelberg Hosp, Dept Clin Pharmacol & Pharmacoepidemiol, Neuenheimer Feld 410, D-69120 Heidelberg, Germany

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2016年 / 130卷

关键词：

Dried blood spots (DBS); Analytical validation; Clinical validation; Clinical applications; PERFORMANCE LIQUID-CHROMATOGRAPHY; QUALITY-OF-LIFE; LC-MS/MS METHOD; CYCLOSPORINE-A; PLASMA SPOTS; REGRESSION PROCEDURES; BIOANALYTICAL METHODS; ANTIRETROVIRAL DRUGS; EBF RECOMMENDATION; INTERNAL STANDARD;

D O I：

10.1016/j.jpba.2016.06.026

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

Dried blood spots (DBS) sampling and their specific advantages are becoming common in analytical and clinical routine. Being first established for metabolic disorder screening in neonates, its use emerged to a broad spectrum of clinical applications. Although DBS are easily generated, the conduction of specific analytical and clinical validation procedures should be obligatory when implementing DBS for clinical purposes, e.g. therapeutic drug monitoring or clinical drug trials. A respective recommendation has already been published by the European Bioanalysis Forum. Since no official guidelines are present, investigators are currently free in DBS procedure development and validation. This review summarizes and discusses published clinical validation procedures in relation to their applications to highlight the clinical feasibility of DBS. (C) 2016 Elsevier B.V. All rights reserved.

引用

页码：231 / 243

页数：13

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