Recommendations for Adaptation and Validation of Commercial Kits for Biomarker Quantification in Drug Development
2015; Future Science Ltd; Volume: 7; Issue: 2 Linguagem: Inglês
10.4155/bio.14.274
ISSN1757-6199
AutoresMasood U Khan, Ronald R. Bowsher, Mark J. Cameron, Viswanath Devanarayan, Steve Keller, Lindsay King, Jean Lee, Alyssa Morimoto, Paul Rhyne, Laurie Stephen, Yuling Wu, Timothy Wyant, D. Richard Lachno,
Tópico(s)Protein purification and stability
ResumoIncreasingly, 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.
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