title: Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
abstract: "The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"
authors.affiliation: Advion BioServices, Ithaca, NY, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Lowes
authors.forename: Jim
authors.initials: J
authors.lastname: Jersey
authors.forename: Ronald
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authors.lastname: Shoup
authors.forename: Fabio
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authors.lastname: Garofolo
authors.forename: Natasha
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authors.lastname: Savoie
authors.forename: Ejvind
authors.initials: E
authors.lastname: Mortz
authors.forename: Shane
authors.initials: S
authors.lastname: Needham
authors.forename: Maria Cruz
authors.initials: MC
authors.lastname: Caturla
authors.forename: Ray
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authors.lastname: Steffen
authors.forename: Curtis
authors.initials: C
authors.lastname: Sheldon
authors.forename: Roger
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authors.lastname: Hayes
authors.forename: Tim
authors.initials: T
authors.lastname: Samuels
authors.forename: Lorella
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authors.lastname: Di Donato
authors.forename: John
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authors.lastname: Kamerud
authors.forename: Steve
authors.initials: S
authors.lastname: Michael
authors.forename: Zhongping John
authors.initials: ZJ
authors.lastname: Lin
authors.forename: Jim
authors.initials: J
authors.lastname: Hillier
authors.forename: Marc
authors.initials: M
authors.lastname: Moussallie
authors.forename: Leonardo
authors.initials: L
authors.lastname: de Souza Teixeira
authors.forename: Mario
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authors.lastname: Rocci
authors.forename: Mike
authors.initials: M
authors.lastname: Buonarati
authors.forename: James
authors.initials: J
authors.lastname: Truog
authors.forename: Saleh
authors.initials: S
authors.lastname: Hussain
authors.forename: Richard
authors.initials: R
authors.lastname: Lundberg
authors.forename: Alan
authors.initials: A
authors.lastname: Breau
authors.forename: Tianyi
authors.initials: T
authors.lastname: Zhang
authors.forename: Jianine
authors.initials: J
authors.lastname: Jonker
authors.forename: Neil
authors.initials: N
authors.lastname: Berger
authors.forename: Sofi
authors.initials: S
authors.lastname: Gagnon-Carignan
authors.forename: Corey
authors.initials: C
authors.lastname: Nehls
authors.forename: Robert
authors.initials: R
authors.lastname: Nicholson
authors.forename: Martijn
authors.initials: M
authors.lastname: Hilhorst
authors.forename: Shane
authors.initials: S
authors.lastname: Karnik
authors.forename: Theo
authors.initials: T
authors.lastname: de Boer
authors.forename: Richard
authors.initials: R
authors.lastname: Houghton
authors.forename: Kirk
authors.initials: K
authors.lastname: Smith
authors.forename: Laura
authors.initials: L
authors.lastname: Cojocaru
authors.forename: Mike
authors.initials: M
authors.lastname: Allen
authors.forename: Tammy
authors.initials: T
authors.lastname: Harter
authors.forename: Saadya
authors.initials: S
authors.lastname: Fatmi
authors.forename: Farhad
authors.initials: F
authors.lastname: Sayyarpour
authors.forename: Jenifer
authors.initials: J
authors.lastname: Vija
authors.forename: Michele
authors.initials: M
authors.lastname: Malone
authors.forename: Dennis
authors.initials: D
authors.lastname: Heller
mesh_terms: D001702:Biopharmaceutics / Q000592:standards*; D002623:Chemistry Techniques, Analytical / Q000379:methods / Q000592:standards*; D004355:Drug Stability; D007391:International Cooperation; D011786:Quality Control; D012015:Reference Standards