title: 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.
abstract: The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.
authors.forename: Steve
authors.initials: S
authors.lastname: Lowes
authors.forename: Jim
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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: Shane
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authors.lastname: Needham
authors.forename: Philippe
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authors.lastname: Couerbe
authors.forename: Tim
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authors.lastname: Lansing
authors.forename: Masood
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authors.lastname: Bhatti
authors.forename: Curtis
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authors.lastname: Sheldon
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authors.lastname: Hayes
authors.forename: Rafiq
authors.initials: R
authors.lastname: Islam
authors.forename: Zhongping
authors.initials: Z
authors.lastname: Lin
authors.forename: Wei
authors.initials: W
authors.lastname: Garofolo
authors.forename: Marc
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authors.lastname: Moussallie
authors.forename: Leonardo de Souza
authors.initials: Lde S
authors.lastname: Teixeira
authors.forename: Thais
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authors.lastname: Rocha
authors.forename: Paula
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authors.lastname: Jardieu
authors.forename: James
authors.initials: J
authors.lastname: Truog
authors.forename: Jenny
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authors.lastname: Lin
authors.forename: Richard
authors.initials: R
authors.lastname: Lundberg
authors.forename: Alan
authors.initials: A
authors.lastname: Breau
authors.forename: Carmen
authors.initials: C
authors.lastname: Dilger
authors.forename: Mohammed
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authors.lastname: Bouhajib
authors.forename: Ann
authors.initials: A
authors.lastname: Levesque
authors.forename: Sofi
authors.initials: S
authors.lastname: Gagnon-Carignan
authors.forename: Rand
authors.initials: R
authors.lastname: Jenkins
authors.forename: Robert
authors.initials: R
authors.lastname: Nicholson
authors.forename: Ming Hung
authors.initials: MH
authors.lastname: Lin
authors.forename: Shane
authors.initials: S
authors.lastname: Karnik
authors.forename: William
authors.initials: W
authors.lastname: DeMaio
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: Saadya
authors.initials: S
authors.lastname: Fatmi
authors.forename: Farhad
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authors.lastname: Sayyarpour
authors.forename: Michele
authors.initials: M
authors.lastname: Malone
authors.forename: Xinping
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authors.lastname: Fang
mesh_terms: D053000:Analytic Sample Preparation Methods; D002138:Calibration; D002623:Chemistry Techniques, Analytical / Q000592:standards*; D002626:Chemistry, Pharmaceutical; D004282:Documentation; D004338:Drug Combinations; D004355:Drug Stability; D005060:Europe; D017408:Guidelines as Topic; D009939:Organizations, Nonprofit / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D004338:Drug Combinations