A biomarker assay validation approach tailored to the context of use and bioanalytical platform

被引：7

作者：

Hickford, Elizabeth S. ^{[1
]}

Dejager, Lien ^{[3
]}

Yuill, Daisy ^{[1
]}

Kotian, Apoorva ^{[1
]}

Shankar, Sucharita ^{[1
]}

Staelens, Ludovicus ^{[2
]}

Ulrichts, Hans ^{[2
,4
]}

Lewis, Sion ^{[1
]}

Louber, Jade ^{[1
,4
]}

Williams, Amanda ^{[1
]}

Le Provost, Gabrielle S. ^{[1
]}

Cutler, Paul ^{[1
]}

机构：

[1] UCB Biopharm UK, Translat Biomarkers & Bioanal, Dev Sci, Bath Rd, Slough SL1 3WE, England

[2] UCB Pharm, Translat Biomarkers & Bioanal, Dev Sci, Chemin Foriest, B-1420 Braine Lalleud, Belgium

[3] UCB Pharm, Precis Med & Biomarkers, Translat Med, Chemin Foriest, B-1420 Braine Lalleud, Belgium

[4] UCB Pharm, Braine Lalleud, Belgium

来源：

BIOANALYSIS | 2023年 / 15卷 / 13期

关键词：

assay; biomarker; context of use; fit-for-purpose; method; validation; CLINICAL IMMUNOHISTOCHEMISTRY; QUALITY-ASSURANCE; PRACTICE GUIDELINES; PRECISION MEDICINE; FLOW-CYTOMETRY; PART; RECOMMENDATIONS; EVOLUTION; ERA; ICSH;

D O I：

10.4155/bio-2023-0110

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

It is widely acknowledged by the bioanalytical and biomarker community that biomarker assay validations should be fit-for-purpose depending on the context of use. The challenge is how to consistently apply these principles in teams responsible for measuring a disparate array of biomarkers, often on multiple analytical platforms, at various stages of the drug discovery and development pipeline and across diverse biology focus areas. To drive consistency, while maintaining the necessary flexibility to allow validations to be driven by scientific rationale and taking into consideration the context of use and associated biological and (pre)analytical factors, a framework applicable across biomarker assays was developed. Herein the authors share their perspective to engage in the ongoing conversation around fit-for-purpose biomarker assay validation.

引用

页码：757 / 771

页数：15

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