The AAPS Journal

, Volume 11, Issue 2, pp 238–241 | Cite as

Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

  • Douglas M. Fast
  • Marian Kelley
  • C. T. Viswanathan
  • Jacqueline O’Shaughnessy
  • S. Peter King
  • Ajai Chaudhary
  • Russell Weiner
  • Anthony J. DeStefano
  • Daniel Tang
Meeting Report

Abstract

The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City III) endorsed the concept that assay methods supporting bioanalytical data in submissions must demonstrate assay reproducibility by using incurred samples. The present Workshop was convened to provide a forum for discussion and consensus building about incurred sample assay reproducibility for both nonclinical and clinical studies. Information about current regulatory perspectives on incurred sample reanalysis (ISR) was presented, implications of ISR for both large and small molecules were discussed, and the steering committee put forth recommendations for performing ISR. These recommendations from the Workshop, along with the subsequent evolution of approaches leading to a robust ISR program, may be used by scientists performing bioanalytical assays for regulated studies to provide additional confirmation of assay reproducibility for incurred samples.

Key words

bioanalytical confirmatory analysis incurred sample(s) reanalysis 

Notes

Acknowledgements

The authors wish to thank the speakers and moderators who participated in the sessions: Jo Marie Smolec, Intertek ALTA Analytical Laboratory; Steven Lowes, Advion BioServices; Surendra Bansal, Hoffman-La Roche; Philip Timmerman, Johnson & Johnson; Binodh DeSilva, Amgen; Marie Rock, Midwest BioResearch LLC; Steven Keller, PDL BioPharma; Viswanath Devanarayan, Abbott Laboratories; Mario Rocci, Prevalere Life Sciences; Min Chang, Biogen Idec; John Smeraglia, Pfizer; Qin Ji, Covance; and Saleh Hussain, Anapharm. The AAPS Contract Research Organization Focus Group, the AAPS Ligand Binding Assays Bioanalytical Focus Group, and the Bioanalytical Focus Group provided support and assistance for the planning of the Workshop. The European Bioanalysis Forum assisted as a co-sponsor of the Workshop. The staff of the AAPS Meetings and Expositions Department, particularly Sharon Pichon, Elizabeth Marburger, and Karen Ellis ably handled the arrangements for the Workshop.*

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Copyright information

© American Association of Pharmaceutical Scientists 2009

Authors and Affiliations

  • Douglas M. Fast
    • 1
  • Marian Kelley
    • 2
  • C. T. Viswanathan
    • 3
  • Jacqueline O’Shaughnessy
    • 3
  • S. Peter King
    • 4
  • Ajai Chaudhary
    • 5
  • Russell Weiner
    • 6
  • Anthony J. DeStefano
    • 7
  • Daniel Tang
    • 8
  1. 1.Pharmacokinetics, Dynamics, and Metabolism, Pfizer Inc.GrotonUSA
  2. 2.MKelley Consulting LLCWest ChesterUSA
  3. 3.Division of Scientific Investigations, Office of Compliance, CDER, US Food and Drug AdministrationSilver SpringUSA
  4. 4.QPS LLCNewarkUSA
  5. 5.Lilly Research LaboratoryIndianapolisUSA
  6. 6.Bristol-Myers-SquibbLawrencevilleUSA
  7. 7.US PharmacopeiaRockvilleUSA
  8. 8.Shanghai ChemPartner Co., LTD.ShanghaiChina

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