title: Method transfer, partial validation, and cross validation: recommendations for best practices and harmonization from the global bioanalysis consortium harmonization team.
abstract: This paper presents the recommendations of the Global Bioanalytical Consortium Harmonization Team on method transfer, partial validation, and cross validation. These aspects of bioanalytical method validation, while important, have received little detailed attention in recent years. The team has attempted to define, separate, and describe these related activities, and present practical guidance in how to apply these techniques.
authors.affiliation: Eurofins, Abingdon, UK, ray.briggs@merckgroup.com.
authors.forename: R J
authors.initials: RJ
authors.lastname: Briggs
authors.forename: R
authors.initials: R
authors.lastname: Nicholson
authors.forename: F
authors.initials: F
authors.lastname: Vazvaei
authors.forename: J
authors.initials: J
authors.lastname: Busch
authors.forename: M
authors.initials: M
authors.lastname: Mabuchi
authors.forename: K S
authors.initials: KS
authors.lastname: Mahesh
authors.forename: M
authors.initials: M
authors.lastname: Brudny-Kloeppel
authors.forename: N
authors.initials: N
authors.lastname: Weng
authors.forename: P A R
authors.initials: PA
authors.lastname: Galvinas
authors.forename: P
authors.initials: P
authors.lastname: Duchene
authors.forename: Pei
authors.initials: P
authors.lastname: Hu
authors.forename: R W
authors.initials: RW
authors.lastname: Abbott
mesh_terms: D001681:Biological Assay / Q000379:methods* / Q000592:standards; D002853:Chromatography, Liquid / Q000379:methods* / Q000592:standards; D013058:Mass Spectrometry / Q000379:methods* / Q000592:standards; D017410:Practice Guidelines as Topic; D054928:Validation Studies as Topic