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Pharmaceutical Research

, Volume 22, Issue 9, pp 1425–1431 | Cite as

Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies

  • JoMarie Smolec
  • Binodh DeSilva
  • Wendell Smith
  • Russell Weiner
  • Marian Kelly
  • Ben Lee
  • Masood Khan
  • Richard Tacey
  • Howard Hill
  • Abbie Celniker
  • Vinod Shah
  • Ronald Bowsher
  • Anthony Mire-Sluis
  • John W. A. Findlay
  • Mary Saltarelli
  • Valerie Quarmby
  • David Lansky
  • Robert Dillard
  • Martin Ullmann
  • Stephen Keller
  • H. Thomas Karnes
Workshop Report

The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.

Key Words

bioanalytical assay biological matrices immunoassay method validation 

References

  1. 1.
    Miller, K. J., Bowsher, R. R., Celniker, A., Gibbons, J., Gupta, S., Lee, J. W., Swanson, J. S. J., Smith, W. C., Weiner, R. S. 2001Workshop on bioanalytical methods validation for macromolecules: summary reportPharm. Res.1813731383CrossRefPubMedGoogle Scholar
  2. 2.
    DeSilva, B., Smith, W., Weiner, R., Kelley, M., Smolec, J., Lee, B., Khan, M., Tacey, R., Hill, H., Celniker, A. 2003Recommendations for the bioanalytical method validation of ligand-binding assays tosupport pharmacokinetic assessments of macromoleculesPharm. Res.2018851900CrossRefPubMedGoogle Scholar
  3. 3.
    International Conference on Harmonization. ICH Q2A. Text on Validation of Analytical Procedures. Federal Register. 1995;60 FR 11260. http://www.fda.gov/cder/guidance/ichq2a.pdf..
  4. 4.
    International Conference on Harmonization. ICH Q2B. Validation of Analytical Procedures Methodology. Federal Register. 1997;62 FR 27463. http://www.fda.gov/cder/guidance/1320fnl.pdf..
  5. 5.
    US Department of Health and Human Services. Draft Guidance for Industry: Analytical Procedures and Methods Validation, Chemistry, Manufacturing and Controls Documentation. Rockville, MD:US Dept of Health and Human Services, Food and Drug Administration. Aug 2000. http://www.fda.gov/cder/guidance/2396dft.pdf..

Copyright information

© Springer Science + Business Media, Inc. 2005

Authors and Affiliations

  • JoMarie Smolec
    • 5
    • 21
  • Binodh DeSilva
    • 1
  • Wendell Smith
    • 2
  • Russell Weiner
    • 3
  • Marian Kelly
    • 4
  • Ben Lee
    • 6
  • Masood Khan
    • 7
  • Richard Tacey
    • 8
  • Howard Hill
    • 9
  • Abbie Celniker
    • 10
  • Vinod Shah
    • 11
  • Ronald Bowsher
    • 12
  • Anthony Mire-Sluis
    • 1
  • John W. A. Findlay
    • 13
  • Mary Saltarelli
    • 14
  • Valerie Quarmby
    • 15
  • David Lansky
    • 16
  • Robert Dillard
    • 17
  • Martin Ullmann
    • 18
  • Stephen Keller
    • 19
  • H. Thomas Karnes
    • 20
  1. 1.Amgen Inc.Thousand OaksUSA
  2. 2.Bowsher Brunelle SmithGreenfieldUSA
  3. 3.Bristol-Myers SquibbPrincetonUSA
  4. 4.CentocorMalvernUSA
  5. 5.Alta Analytical LaboratorySan DiegoUSA
  6. 6.Pfizer Global Research and DevelopmentAnn ArborUSA
  7. 7.Covance LaboratoriesChantillyUSA
  8. 8.PPD DevelopmentRichmondUSA
  9. 9.HLSAlconburyUK
  10. 10.Millennium PharmaceuticalsCambridgeUSA
  11. 11.Food and Drug AdministrationRockvilleUSA
  12. 12.LINCO Diagnostic ServicesSt. CharlesUSA
  13. 13.Pfizer Global ResearchGrotonUSA
  14. 14.Abbott LaboratoriesAbbott ParkUSA
  15. 15.GenentechSan FranciscoUSA
  16. 16.Lansky Consulting LLCBurlingtonUSA
  17. 17.Takeda Pharmaceuticals N.A.LincolnshireUSA
  18. 18.MDS Pharma ServicesZurichSwitzerland
  19. 19.Protein Design Labs, Inc.FremontUSA
  20. 20.Virginia Commonwealth UniversityRichmondUSA
  21. 21.San DiegoUSA

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