title: Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development.
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.
authors.affiliation: KCAS Bioanalytical Services, 12400 Shawnee Mission Pkwy, Shawnee, KS 66216, USA.
authors.forename: Masood U
authors.initials: MU
authors.lastname: Khan
authors.forename: Ronald R
authors.initials: RR
authors.lastname: Bowsher
authors.forename: Mark
authors.initials: M
authors.lastname: Cameron
authors.forename: Viswanath
authors.initials: V
authors.lastname: Devanarayan
authors.forename: Steve
authors.initials: S
authors.lastname: Keller
authors.forename: Lindsay
authors.initials: L
authors.lastname: King
authors.forename: Jean
authors.initials: J
authors.lastname: Lee
authors.forename: Alyssa
authors.initials: A
authors.lastname: Morimoto
authors.forename: Paul
authors.initials: P
authors.lastname: Rhyne
authors.forename: Laurie
authors.initials: L
authors.lastname: Stephen
authors.forename: Yuling
authors.initials: Y
authors.lastname: Wu
authors.forename: Timothy
authors.initials: T
authors.lastname: Wyant
authors.forename: D Richard
authors.initials: DR
authors.lastname: Lachno
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D002138:Calibration; D055808:Drug Discovery / Q000379:methods*; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007118:Immunoassay / Q000592:standards; D011933:Reagent Kits, Diagnostic
chemical_list: D015415:Biomarkers; D011933:Reagent Kits, Diagnostic