title: 2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop.
abstract: The 3rd Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis was organized by the Calibration and Validation Group as a 1.5-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges. A consensus was reached among panelists and attendees on many points regarding method validation of small molecules.
authors.affiliation: Algorithme Pharma Inc., Laval (Montreal) QC, Canada.
authors.forename: Natasha
authors.initials: N
authors.lastname: Savoie
authors.forename: Fabio
authors.initials: F
authors.lastname: Garofolo
authors.forename: Peter
authors.initials: P
authors.lastname: van Amsterdam
authors.forename: Brian P
authors.initials: BP
authors.lastname: Booth
authors.forename: Douglas M
authors.initials: DM
authors.lastname: Fast
authors.forename: Michael
authors.initials: M
authors.lastname: Lindsay
authors.forename: Steve
authors.initials: S
authors.lastname: Lowes
authors.forename: Robert
authors.initials: R
authors.lastname: Masse
authors.forename: Louise
authors.initials: L
authors.lastname: Mawer
authors.forename: Eric
authors.initials: E
authors.lastname: Ormsby
authors.forename: Rupinder
authors.initials: R
authors.lastname: Phull
authors.forename: Mario L
authors.initials: ML
authors.lastname: Rocci
authors.forename: Patrick T
authors.initials: PT
authors.lastname: Vallano
authors.forename: Xia
authors.initials: X
authors.lastname: Yin
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis*; D054928:Validation Studies as Topic
chemical_list: D004364:Pharmaceutical Preparations