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

页码：533 / 536

页数：4

共 50 条

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