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

  • Review Article
  • Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium
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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.

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References

  1. Shah VP, Midha KK, Dighe S, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report. Eur J Drug Metab Pharmacokinet. 1991;16:249–55.

    Article  CAS  PubMed  Google Scholar 

  2. Shah VP, Midha KK, Findlay JW, et al. Bioanalytical method validation—a revisit with a decade of progress. Pharm Res. 2000;17:1551–7.

    Article  CAS  PubMed  Google Scholar 

  3. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine (2001) Guidance for industry: bioanalytical method validation

  4. European Medicines Agency, Committee for Medicinal Products for Human Use (2011) Guideline on bioanalytical method validation

  5. Agência Nacional de Vigilância Sanitária, Brazil. Resolução – RDC No 27. May 2012.

  6. Ministry of Health, Labour and Welfare, Japan (2013) Guideline on bioanalytical method validation in pharmaceutical development

  7. DeSilva B, Smith W, Weiner R, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20:1885–900.

    Article  CAS  PubMed  Google Scholar 

  8. Viswanathan CT, Bansal S, Booth B, et al. Workshop/conference report—quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007;9:E30–42.

    Article  PubMed Central  Google Scholar 

  9. Bansal S, DeStefano A. Key elements of bioanalytical method validation for small molecules. AAPS J. 2007;9:E109–14.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  10. Nowatzke W, Woolf E. Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples. AAPS J. 2007;9:E117–22.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  11. Lowes S, Jersey J, Shoup R, et al. Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for bioanalysis. Bioanalysis. 2011;3:1323–32.

    Article  CAS  PubMed  Google Scholar 

  12. Freisleben A, Brudny-Klöppel M, Mulder H, et al. Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis. Bioanalysis. 2011;3:1333–6.

    Article  CAS  PubMed  Google Scholar 

  13. Lowes S, Boterman M, Doig M, et al. Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for bioanalysis (GCC). Bioanalysis. 2012;4:2117–26.

    Article  CAS  PubMed  Google Scholar 

  14. Van Amsterdam P, Companjen A, Brudny-Kloeppel M, et al. The European Bioanalysis Forum community’s evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method Validation. Bioanalysis. 2013;5:645–59.

    Article  PubMed  Google Scholar 

  15. Sennbro CJ, Knutsson M, Timmerman P, et al. Anticoagulant counter ion impact on bioanalytical LC-MS/MS assay performance: additional validation required? Bioanalysis. 2011;3:2389–91.

    Article  CAS  PubMed  Google Scholar 

  16. Timm U, Wall M, Dell D. A new approach for dealing with the stability of drugs in biological fluids. J Pharm Sci. 1985;74:972–7.

    Article  CAS  PubMed  Google Scholar 

  17. Houghton R, Horro Pita C, Ward I, Macarthur R. Generic approach to validation of small-molecule LC-MS/MS biomarker assays. Bioanalysis. 2009;1:1365–74.

    Article  CAS  PubMed  Google Scholar 

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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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Authors and Affiliations

  1. Bioanalytical Laboratory, PRA, Westerbrink 3, 9405 BJ, Assen, The Netherlands

    Nico van de Merbel

  2. Algorithme Pharma, Montreal, Canada

    Natasha Savoie

  3. Alkem Laboratories, Mumbai, India

    Manish Yadav

  4. Astellas Pharma, Osaka, Japan

    Yoshiaki Ohtsu

  5. Biogen Idec, Cambridge, MA, USA

    Joleen White

  6. CAEP, Sao Paulo, Brazil

    Maria Francesca Riccio

  7. GlaxoSmithKline, Shanghai, China

    Kelly Dong

  8. Janssen Research & Development, Beerse, Belgium

    Ronald de Vries

  9. PPD, Middleton, WI, USA

    Julie Diancin

Authors
  1. Nico van de Merbel
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  2. Natasha Savoie
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  3. Manish Yadav
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  4. Yoshiaki Ohtsu
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  5. Joleen White
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  6. Maria Francesca Riccio
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  7. Kelly Dong
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  8. Ronald de Vries
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  9. Julie Diancin
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Corresponding author

Correspondence to Nico van de Merbel.

Additional information

Guest Editors: Binodh DeSilva and Philip Timmerman

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van de Merbel, N., Savoie, N., Yadav, M. et al. Stability: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team. AAPS J 16, 392–399 (2014). https://doi.org/10.1208/s12248-014-9573-z

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  • DOI: https://doi.org/10.1208/s12248-014-9573-z

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