Pharmaceutical Research

, Volume 17, Issue 12, pp 1551–1557 | Cite as

Bioanalytical Method Validation—A Revisit with a Decade of Progress

  • Vinod P. Shah
  • Kamal K. Midha
  • John W. A. Findlay
  • Howard M. Hill
  • James D. Hulse
  • Iain J. McGilveray
  • Gordon McKay
  • Krys J. Miller
  • Rabindra N. Patnaik
  • Mark L. Powell
  • Alfred Tonelli
  • C. T. Viswanathan
  • Avraham Yacobi
Article

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REFERENCES

  1. [FDA] Food and Drug Administration: International Conference on Harmonization: Guideline on validation of analytical procedures: methodology, Federal Register 60(40): 11200–11262, 1995.Google Scholar
  2. [FDA] Food and Drug Administration: International Conference on Harmonization: Guideline on validation of analytical procedures: definitions and terminology, Federal Register 62(96): 27464–27467, 1997.Google Scholar
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Copyright information

© Plenum Publishing Corporation 2000

Authors and Affiliations

  • Vinod P. Shah
    • 1
  • Kamal K. Midha
    • 2
  • John W. A. Findlay
    • 3
  • Howard M. Hill
    • 4
  • James D. Hulse
    • 5
  • Iain J. McGilveray
    • 6
  • Gordon McKay
    • 2
  • Krys J. Miller
    • 7
  • Rabindra N. Patnaik
    • 1
  • Mark L. Powell
    • 8
  • Alfred Tonelli
    • 9
  • C. T. Viswanathan
    • 1
  • Avraham Yacobi
    • 10
  1. 1.Center for Drug Evaluation and ResearchFood and Drug AdministrationRockville
  2. 2.University of Saskatchewan, SaskatoonSaskatchewanCanada, S7NOWO
  3. 3.Pharmacia CorporationSkokie
  4. 4.Huntingdon Life Sciences, HuntingdonCambridgeUK
  5. 5.MDS HarrisLincoln
  6. 6.McGilveray Pharmacon Inc.NepeanCanada
  7. 7.AmgenThousand Oaks
  8. 8.Bristol-Meyers Squibb, Inc.New Brunswick
  9. 9.Purdue Pharma, LPArdsley
  10. 10.Taro Pharmaceuticals USA INC.Hawthorne

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