Recommendations for Adaptation and Validation of Commercial Kits for Biomarker Quantification in Drug Development

Increasingly, commercial immunoassay kits are used to support drug discovery and development. Longitudinally consistent kit performance is crucial, but the degree to which kits and reagents are characterized by manufacturers is not standardized, nor are the approaches by users to adapt them and eval...

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Published inBioanalysis Vol. 7; no. 2; pp. 229 - 242
Main Authors Khan, Masood U, Bowsher, Ronald R, Cameron, Mark, Devanarayan, Viswanath, Keller, Steve, King, Lindsay, Lee, Jean, Morimoto, Alyssa, Rhyne, Paul, Stephen, Laurie, Wu, Yuling, Wyant, Timothy, Lachno, D Richard
Format Journal Article
LanguageEnglish
Published England 01.01.2015
Subjects
Biomarkers - analysis
Calibration
Drug Discovery - methods
Government Regulation
Guidelines as Topic
Humans
Immunoassay - standards
Reagent Kits, Diagnostic
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Abstract Increasingly, commercial immunoassay kits are used to support drug discovery and development. Longitudinally consistent kit performance is crucial, but the degree to which kits and reagents are characterized by manufacturers is not standardized, nor are the approaches by users to adapt them and evaluate their performance through validation prior to use. These factors can negatively impact data quality. This paper offers a systematic approach to assessment, method adaptation and validation of commercial immunoassay kits for quantification of biomarkers in drug development, expanding upon previous publications and guidance. These recommendations aim to standardize and harmonize user practices, contributing to reliable biomarker data from commercial immunoassays, thus, enabling properly informed decisions during drug development.
AbstractList Increasingly, commercial immunoassay kits are used to support drug discovery and development. Longitudinally consistent kit performance is crucial, but the degree to which kits and reagents are characterized by manufacturers is not standardized, nor are the approaches by users to adapt them and evaluate their performance through validation prior to use. These factors can negatively impact data quality. This paper offers a systematic approach to assessment, method adaptation and validation of commercial immunoassay kits for quantification of biomarkers in drug development, expanding upon previous publications and guidance. These recommendations aim to standardize and harmonize user practices, contributing to reliable biomarker data from commercial immunoassays, thus, enabling properly informed decisions during drug development.
Author Khan, Masood U
Cameron, Mark
Bowsher, Ronald R
Morimoto, Alyssa
Stephen, Laurie
Wyant, Timothy
King, Lindsay
Lee, Jean
Rhyne, Paul
Devanarayan, Viswanath
Keller, Steve
Lachno, D Richard
Wu, Yuling
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Snippet Increasingly, commercial immunoassay kits are used to support drug discovery and development. Longitudinally consistent kit performance is crucial, but the...
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SubjectTerms Biomarkers - analysis
Calibration
Drug Discovery - methods
Government Regulation
Guidelines as Topic
Humans
Immunoassay - standards
Reagent Kits, Diagnostic
Title Recommendations for Adaptation and Validation of Commercial Kits for Biomarker Quantification in Drug Development
URI https://www.ncbi.nlm.nih.gov/pubmed/25587839
Volume 7
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