title: Repeat analysis and incurred sample reanalysis: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.
abstract: The A7 harmonization team (A7 HT), a part of the Global Bioanalysis Consortium (GBC), focused on reviewing best practices for repeat analysis and incurred sample reanalysis (ISR) as applied during regulated bioanalysis. With international representation from Europe, Latin America, North America, and the Asia Pacific region, the team first collated common practices and guidance recommendations and assessed their suitability from both a scientific and logistical perspective. Subsequently, team members developed best practice recommendations and refined them through discussions and presentations with industry experts at scientific meetings. This review summarizes the team findings and best practice recommendations. The few topics where no consensus could be reached are also discussed. The A7 HT recommendations, together with those from the other GBC teams, provide the basis for future international harmonization of regulated bioanalytical practices.
authors.affiliation: Pfizer, PDM-NBE, Pearl River, New York, USA, eric.fluhler@pfizer.com.
authors.forename: Eric
authors.initials: E
authors.lastname: Fluhler
authors.forename: Faye
authors.initials: F
authors.lastname: Vazvaei
authors.forename: Puran
authors.initials: P
authors.lastname: Singhal
authors.forename: Petra
authors.initials: P
authors.lastname: Vinck
authors.forename: Wenkui
authors.initials: W
authors.lastname: Li
authors.forename: Jignesh
authors.initials: J
authors.lastname: Bhatt
authors.forename: Theo
authors.initials: T
authors.lastname: de Boer
authors.forename: Ajai
authors.initials: A
authors.lastname: Chaudhary
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tangiuchi
authors.forename: Vinicius
authors.initials: V
authors.lastname: Rezende
authors.forename: Dafang
authors.initials: D
authors.lastname: Zhong
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D003299:Cooperative Behavior; D007391:International Cooperation; D017410:Practice Guidelines as Topic; D054928:Validation Studies as Topic