The AAPS Journal

, Volume 16, Issue 3, pp 392–399 | Cite as

Stability: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

  • Nico van de Merbel
  • Natasha Savoie
  • Manish Yadav
  • Yoshiaki Ohtsu
  • Joleen White
  • Maria Francesca Riccio
  • Kelly Dong
  • Ronald de Vries
  • Julie Diancin
Review Article Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium
Part of the following topical collections:
  1. Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium

Abstract

This paper provides a comprehensive overview of stability-related aspects of quantitative bioanalysis and recommends science-based best practices, covering small and large molecules as well as chromatographic and ligand-binding assays. It addresses general aspects, such as the use of reference values, transferability and treatment of failing stability results, and also focuses on specific types of stability assessment: bench-top, freeze/thaw and long-term frozen stability, stock stability, extract stability, stability in whole blood, tissue and urine, and stability of endogenous analytes, in special matrix types and in incurred samples.

KEY WORDS

GBC regulated bioanalysis stability assessment 

Notes

Acknowledgments

The authors want to express their gratitude to Marian Kelley, Lauren Stevenson, and Binodh DeSilva for their valuable discussions during the preparation of the manuscript.

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Copyright information

© American Association of Pharmaceutical Scientists 2014

Authors and Affiliations

  • Nico van de Merbel
    • 1
  • Natasha Savoie
    • 2
  • Manish Yadav
    • 3
  • Yoshiaki Ohtsu
    • 4
  • Joleen White
    • 5
  • Maria Francesca Riccio
    • 6
  • Kelly Dong
    • 7
  • Ronald de Vries
    • 8
  • Julie Diancin
    • 9
  1. 1.Bioanalytical LaboratoryPRAAssenThe Netherlands
  2. 2.Algorithme PharmaMontrealCanada
  3. 3.Alkem LaboratoriesMumbaiIndia
  4. 4.Astellas PharmaOsakaJapan
  5. 5.Biogen IdecCambridgeUSA
  6. 6.CAEPSao PauloBrazil
  7. 7.GlaxoSmithKlineShanghaiChina
  8. 8.Janssen Research & DevelopmentBeerseBelgium
  9. 9.PPDMiddletonUSA

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