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Pharmaceutical Research

, Volume 18, Issue 9, pp 1373–1383 | Cite as

Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report

  • Krys J. Miller
  • Ronald R. Bowsher
  • Abbie Celniker
  • Jacqueline Gibbons
  • Shalini Gupta
  • Jean W. Lee
  • Steve J. Swanson
  • Wendell C. Smith
  • Russell S. Weiner
  • Daan J. A. Crommelin
  • Ira Das
  • Binodh S. DeSilva
  • Robert F. Dillard
  • Michael Geier
  • Han Gunn
  • Masood N. Khan
  • Dean W. Knuth
  • Michael Kunitani
  • Gerald D. Nordblom
  • Rene J. A. Paulussen
  • Jeffrey M. Sailstad
  • Richard L. Tacey
  • Ann Watson
Conference Report
bioanalytical methods validation macromolecules ligand-binding assay immunoassay ELISA EIA RIA anti-drug bioassay biomarker total error assay quality control acceptance criteria specificity accuracy precision recovery calibration drug development neutralizing antibody 

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Copyright information

© Plenum Publishing Corporation 2001

Authors and Affiliations

  • Krys J. Miller
    • 1
  • Ronald R. Bowsher
    • 2
  • Abbie Celniker
    • 3
  • Jacqueline Gibbons
    • 4
  • Shalini Gupta
    • 5
  • Jean W. Lee
    • 6
  • Steve J. Swanson
    • 5
  • Wendell C. Smith
    • 2
  • Russell S. Weiner
    • 7
  • Daan J. A. Crommelin
    • 8
  • Ira Das
    • 9
  • Binodh S. DeSilva
    • 10
  • Robert F. Dillard
    • 11
  • Michael Geier
    • 12
  • Han Gunn
    • 13
  • Masood N. Khan
    • 14
  • Dean W. Knuth
    • 15
  • Michael Kunitani
    • 16
  • Gerald D. Nordblom
    • 17
  • Rene J. A. Paulussen
    • 18
  • Jeffrey M. Sailstad
    • 19
  • Richard L. Tacey
    • 20
  • Ann Watson
    • 13
  1. 1.Pharmacokinetics and Drug Metabolism at Amgen, Inc.Thousand Oaks
  2. 2.Eli Lilly and Co.Indianapolis
  3. 3.Genetics Institute/Wyeth Ayerst ResearchAndover
  4. 4.Jacqueline Gibbons ConsultingPiedmont
  5. 5.Clinical Immunology at Amgen, Inc.Thousand Oaks
  6. 6.Jean Lee, MDS Pharma ServicesLincoln
  7. 7.Bristol-Myers SquibbNew Brunswick
  8. 8.University of UtrechtUtrecht, NETNetherlands
  9. 9.Washington UniversitySt. Louis
  10. 10.Procter & Gamble PharmaceuticalsMason
  11. 11.Pharmacia CorporationSkokie
  12. 12.Roche Molecular SystemsPleasanton
  13. 13.Pharmacokinetics and Drug Metabolism at Amgen, Inc.Thousand Oaks
  14. 14.MedImmune, Inc.Frederick
  15. 15.Pharmacia & Upjohn, Inc.Kalamazoo
  16. 16.Corte Madera
  17. 17.Warner-Lambert/Parke-DavisAnn Arbor
  18. 18.Phoenix Int'l Life SciencesSt. LaurentCanada
  19. 19.Glaxo Wellcome, Inc.Res. Triangle Park
  20. 20.PPD DevelopmentRichmond

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