title: 2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.
abstract: The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.
authors.affiliation: Algorithme Pharma Inc., Laval (Montreal) Quebec, H7V 4B3, Canada. fgarofolo@algopharm.com
authors.forename: Fabio
authors.initials: F
authors.lastname: Garofolo
authors.forename: Mario L
authors.initials: ML
authors.lastname: Rocci
authors.forename: Isabelle
authors.initials: I
authors.lastname: Dumont
authors.forename: Suzanne
authors.initials: S
authors.lastname: Martinez
authors.forename: Steve
authors.initials: S
authors.lastname: Lowes
authors.forename: Eric
authors.initials: E
authors.lastname: Woolf
authors.forename: Peter
authors.initials: P
authors.lastname: van Amsterdam
authors.forename: Surendra
authors.initials: S
authors.lastname: Bansal
authors.forename: Ariadna Cristina Gomes
authors.initials: AC
authors.lastname: Barra
authors.forename: Ronald
authors.initials: R
authors.lastname: Bauer
authors.forename: Brian P
authors.initials: BP
authors.lastname: Booth
authors.forename: Montserrat
authors.initials: M
authors.lastname: Carrasco-Triguero
authors.forename: Binodh
authors.initials: B
authors.lastname: DeSilva
authors.forename: John
authors.initials: J
authors.lastname: Dunn
authors.forename: Keith
authors.initials: K
authors.lastname: Gallicano
authors.forename: Dominique
authors.initials: D
authors.lastname: Gouty
authors.forename: Stacy
authors.initials: S
authors.lastname: Ho
authors.forename: Richard
authors.initials: R
authors.lastname: Hucker
authors.forename: Mohammed
authors.initials: M
authors.lastname: Jemal
authors.forename: Noriko
authors.initials: N
authors.lastname: Katori
authors.forename: Olivier
authors.initials: O
authors.lastname: Le Blaye
authors.forename: Jean
authors.initials: J
authors.lastname: Lee
authors.forename: Wenkui
authors.initials: W
authors.lastname: Li
authors.forename: Steve
authors.initials: S
authors.lastname: Michael
authors.forename: Corey
authors.initials: C
authors.lastname: Nehls
authors.forename: Robert
authors.initials: R
authors.lastname: Nicholson
authors.forename: Eric
authors.initials: E
authors.lastname: Ormsby
authors.forename: Daniel
authors.initials: D
authors.lastname: Tang
authors.forename: C T
authors.initials: CT
authors.lastname: Viswanathan
authors.forename: Russell
authors.initials: R
authors.lastname: Weiner
authors.forename: Graeme
authors.initials: G
authors.lastname: Young
mesh_terms: D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards; D059788:Dried Blood Spot Testing / Q000379:methods / Q000592:standards; D004345:Drug Industry; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D013058:Mass Spectrometry / Q000295:instrumentation / Q000379:methods / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis*; D018581:Technology Transfer; D046888:Tissue Array Analysis / Q000379:methods / Q000592:standards; D054928:Validation Studies as Topic
chemical_list: D004364:Pharmaceutical Preparations