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

• Published in: Bioanalysis 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
• Language: English
• Published: England 01.01.2015
• Subjects: Biomarkers - analysis; Calibration; Drug Discovery - methods; Government Regulation; Guidelines as Topic; Humans; Immunoassay - standards; Reagent Kits, Diagnostic

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...