Recommendations for Adaptation and Validation of Commercial Kits for Biomarker Quantification in Drug Development - 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; et al. (Bioanalysis, 2015)
Keywords: Biomarkers - analysis; Calibration; Drug Discovery - methods; Government Regulation; Guidelines as Topic; Humans; Immunoassay - standards; Reagent Kits, Diagnostic