title: 2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.
abstract: Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot' topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this year's workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis.
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: Binodh
authors.initials: B
authors.lastname: DeSilva
authors.forename: Fabio
authors.initials: F
authors.lastname: Garofolo
authors.forename: Mario
authors.initials: M
authors.lastname: Rocci
authors.forename: Suzanne
authors.initials: S
authors.lastname: Martinez
authors.forename: Isabelle
authors.initials: I
authors.lastname: Dumont
authors.forename: France
authors.initials: F
authors.lastname: Landry
authors.forename: Catherine
authors.initials: C
authors.lastname: Dicaire
authors.forename: Gabriella
authors.initials: G
authors.lastname: Szekely-Klepser
authors.forename: Russell
authors.initials: R
authors.lastname: Weiner
authors.forename: Mark
authors.initials: M
authors.lastname: Arnold
authors.forename: Surendra
authors.initials: S
authors.lastname: Bansal
authors.forename: Kevin
authors.initials: K
authors.lastname: Bateman
authors.forename: Ronald
authors.initials: R
authors.lastname: Bauer
authors.forename: Brian
authors.initials: B
authors.lastname: Booth
authors.forename: Scott
authors.initials: S
authors.lastname: Davis
authors.forename: Sherri
authors.initials: S
authors.lastname: Dudal
authors.forename: Dominique
authors.initials: D
authors.lastname: Gouty
authors.forename: John
authors.initials: J
authors.lastname: Grundy
authors.forename: Sam
authors.initials: S
authors.lastname: Haidar
authors.forename: Roger
authors.initials: R
authors.lastname: Hayes
authors.forename: Mohammed
authors.initials: M
authors.lastname: Jemal
authors.forename: Surinder
authors.initials: S
authors.lastname: Kaur
authors.forename: Marian
authors.initials: M
authors.lastname: Kelley
authors.forename: Magnus
authors.initials: M
authors.lastname: Knutsson
authors.forename: Olivier
authors.initials: O
authors.lastname: Le Blaye
authors.forename: Jean
authors.initials: J
authors.lastname: Lee
authors.forename: Steve
authors.initials: S
authors.lastname: Lowes
authors.forename: Mark
authors.initials: M
authors.lastname: Ma
authors.forename: Toshinari
authors.initials: T
authors.lastname: Mitsuoka
authors.forename: João Tavares
authors.initials: JT
authors.lastname: Neto
authors.forename: Robert
authors.initials: R
authors.lastname: Nicholson
authors.forename: Eric
authors.initials: E
authors.lastname: Ormsby
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Sailstad
authors.forename: Lauren
authors.initials: L
authors.lastname: Stevenson
authors.forename: Daniel
authors.initials: D
authors.lastname: Tang
authors.forename: Jan
authors.initials: J
authors.lastname: Welink
authors.forename: C T
authors.initials: CT
authors.lastname: Viswanathan
authors.forename: Laixin
authors.initials: L
authors.lastname: Wang
authors.forename: Eric
authors.initials: E
authors.lastname: Woolf
authors.forename: Eric
authors.initials: E
authors.lastname: Yang
mesh_terms: D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards; D059788:Dried Blood Spot Testing / Q000379:methods; D004345:Drug Industry; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards; D013058:Mass Spectrometry / Q000379:methods* / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011994:Recombinant Proteins / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D054928:Validation Studies as Topic
chemical_list: D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins