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Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies

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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.

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References

  1. K. J. Miller R. R. Bowsher A. Celniker J. Gibbons S. Gupta J. W. Lee J. S. J. Swanson W. C. Smith R. S. Weiner (2001) ArticleTitleWorkshop on bioanalytical methods validation for macromolecules: summary report Pharm. Res. 18 1373–1383 Occurrence Handle10.1023/A:1013062600566 Occurrence Handle11683255

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  2. B. DeSilva W. Smith R. Weiner M. Kelley J. Smolec B. Lee M. Khan R. Tacey H. Hill A. Celniker (2003) ArticleTitleRecommendations for the bioanalytical method validation of ligand-binding assays tosupport pharmacokinetic assessments of macromolecules Pharm. Res. 20 IssueID11 1885–1900 Occurrence Handle10.1023/B:PHAM.0000003390.51761.3d Occurrence Handle14661937

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Author information

Authors and Affiliations

  1. Amgen Inc., Thousand Oaks, California, USA

    Binodh DeSilva & Anthony Mire-Sluis

  2. Bowsher Brunelle Smith, Greenfield, Indiana, USA

    Wendell Smith

  3. Bristol-Myers Squibb, Princeton, New Jersey, USA

    Russell Weiner

  4. Centocor, Malvern, Pennsylvania, USA

    Marian Kelly

  5. Alta Analytical Laboratory, San Diego, California, USA

    JoMarie Smolec

  6. Pfizer Global Research and Development, Ann Arbor, Michigan, USA

    Ben Lee

  7. Covance Laboratories, Chantilly, Virginia, USA

    Masood Khan

  8. PPD Development, Richmond, Virginia, USA

    Richard Tacey

  9. HLS, Alconbury, Cambridgeshire, UK

    Howard Hill

  10. Millennium Pharmaceuticals, Cambridge, Massachusetts, USA

    Abbie Celniker

  11. Food and Drug Administration, Rockville, Maryland, USA

    Vinod Shah

  12. LINCO Diagnostic Services, St. Charles, Missouri, USA

    Ronald Bowsher

  13. Pfizer Global Research, Groton, Connecticut, USA

    John W. A. Findlay

  14. Abbott Laboratories, Abbott Park, Illinois, USA

    Mary Saltarelli

  15. Genentech, San Francisco, California, USA

    Valerie Quarmby

  16. Lansky Consulting LLC, Burlington, Vermont, USA

    David Lansky

  17. Takeda Pharmaceuticals N.A., Lincolnshire, Illinois, USA

    Robert Dillard

  18. MDS Pharma Services, Zurich, Switzerland

    Martin Ullmann

  19. Protein Design Labs, Inc., Fremont, California, USA

    Stephen Keller

  20. Virginia Commonwealth University, Richmond, Virginia, USA

    H. Thomas Karnes

  21. 3985 Sorrento Valley Blvd, Ste C, San Diego, California, 92121, USA

    JoMarie Smolec

Authors
  1. JoMarie Smolec
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  2. Binodh DeSilva
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  3. Wendell Smith
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  4. Russell Weiner
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  5. Marian Kelly
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  6. Ben Lee
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  7. Masood Khan
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  8. Richard Tacey
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  9. Howard Hill
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  10. Abbie Celniker
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  11. Vinod Shah
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  12. Ronald Bowsher
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  13. Anthony Mire-Sluis
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  14. John W. A. Findlay
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  15. Mary Saltarelli
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  16. Valerie Quarmby
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  17. David Lansky
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  18. Robert Dillard
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  19. Martin Ullmann
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  20. Stephen Keller
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  21. H. Thomas Karnes
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Corresponding author

Correspondence to JoMarie Smolec.

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Smolec, J., DeSilva, B., Smith, W. et al. Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies. Pharm Res 22, 1425–1431 (2005). https://doi.org/10.1007/s11095-005-5917-9

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  • DOI: https://doi.org/10.1007/s11095-005-5917-9

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