Considerations for drug development biomarker assays in the clinical laboratory

被引：1
|
作者：
Arnold, Mark E. [1 ]
Allinson, John L. [2 ]
Piccoli, Steven P. [3 ]
机构：
[1] Bioanalyt Solut Integrat, Westampton, NJ 08060 USA
[2] Immunologix Labs, Biomarker Lab, Tampa, FL 33634 USA
[3] Sun Pharm Adv Res Co Ltd, Clin Sci, Cranbury, NJ 08512 USA
来源：
BIOANALYSIS | 2023年 / 15卷 / 10期
关键词：
biomarkers; BMV; CAP; CLIA; clinical laboratory; context of use; drug development; regulations; US FDA; validation;
D O I：
10.4155/bio-2023-0101
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
引用
收藏
页码：533 / 536
页数：4
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