The AAPS Journal

, Volume 16, Issue 6, pp 1167–1174 | Cite as

Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

  • Eric Fluhler
  • Faye Vazvaei
  • Puran Singhal
  • Petra Vinck
  • Wenkui Li
  • Jignesh Bhatt
  • Theo de Boer
  • Ajai Chaudhary
  • Masahiro Tangiuchi
  • Vinicius Rezende
  • Dafang Zhong
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

The A7 harmonization team (A7 HT), a part of the Global Bioanalysis Consortium (GBC), focused on reviewing best practices for repeat analysis and incurred sample reanalysis (ISR) as applied during regulated bioanalysis. With international representation from Europe, Latin America, North America, and the Asia Pacific region, the team first collated common practices and guidance recommendations and assessed their suitability from both a scientific and logistical perspective. Subsequently, team members developed best practice recommendations and refined them through discussions and presentations with industry experts at scientific meetings. This review summarizes the team findings and best practice recommendations. The few topics where no consensus could be reached are also discussed. The A7 HT recommendations, together with those from the other GBC teams, provide the basis for future international harmonization of regulated bioanalytical practices.

KEY WORDS

harmonization incurred sample reanalysis regulated bioanalysis repeat analysis 

Notes

ACKNOWLEDGMENTS

We would like to acknowledge the contributions of Bernard Jeanbaptiste (SGS Life Science Services) for his input early in our team discussions.

REFERENCES

  1. 1.
    Shah VP, Midha KK, Dighe SV, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies (conference report). Pharm Res. 1992;9:588–92.CrossRefGoogle Scholar
  2. 2.
    Shah VP, Midha KK, Findlay JWA, et al. Bioanalytical method validation—a revisit with a decade of progress. Pharm Res. 2000;17(12):1551–7.PubMedCrossRefGoogle Scholar
  3. 3.
    Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, et al. Workshop/conference report—quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007;9(1):E30–42.PubMedCentralCrossRefGoogle Scholar
  4. 4.
    FDA. Guidance for industry: bioanalytical method validation. US Department of Health and Human Services, Food and Drug Administration (CDER and CVM), May 2001; Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf.
  5. 5.
    Van Amsterdam P, Arnold M, Bansal S, Fast D, et al. Building the Global Bioanalysis Consortium—working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation. Bioanalysis. 2010;2(11):1801–3.PubMedCrossRefGoogle Scholar
  6. 6.
    European Medicines Agency E. Guideline on bioanalytical method validation, MEA/CHMP/EWP/192217/2009, Committee for Medicinal Products for Human Use (CHMP), 21 July 2011; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
  7. 7.
    ANVISA. Resolution RE No. 899, of May 29, 2003. Brazil, D.O.U. 02/jun/2003: Brazilian National Surveillance Agency (ANVISA); 2003; Available from: http://www.anvisa.gov.br/hotsite/genericos/legis/resolucoes/2003/899_03re_e.pdf.
  8. 8.
    ANVISA. Resolution RE 1170, of April 19, 2006. Brazil: Brazilian National Surveillance Agency (ANVISA); 2006.Google Scholar
  9. 9.
    ANVISA. Resolution RDC No. 27, of May 27, 2012. Brazil, D.O.U. 22/may/2012: Brazilian National Surveillance Agency (ANVISA); 2012.Google Scholar
  10. 10.
    Guideline on Bioanalytical Method Validation in Pharmaceutical Development (25 July 2013, MHLW, Japan); Available from: http://www.nihs.go.jp/drug/BMV/250913_BMV-GL_E.pdf.
  11. 11.
    Fast DM, Kelley M, Viswanathan CT, O’Shaughnessy J, King SP, Chaudhary A, et al. Workshop report and follow-up—AAPS Workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples—implications of Crystal City recommendations. AAPS J. 2009;11(2):238–41.PubMedCentralPubMedCrossRefGoogle Scholar
  12. 12.
    FDA. Guidance for industry: bioanalytical method validation. Draft Guidance. US Department of Health and Human Services, Food and Drug Administration, (CDER and CVM); September 2013, Revision 1; Available From: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf.

Copyright information

© American Association of Pharmaceutical Scientists 2014

Authors and Affiliations

  • Eric Fluhler
    • 1
    • 12
  • Faye Vazvaei
    • 2
  • Puran Singhal
    • 3
  • Petra Vinck
    • 4
  • Wenkui Li
    • 5
  • Jignesh Bhatt
    • 6
  • Theo de Boer
    • 7
  • Ajai Chaudhary
    • 8
  • Masahiro Tangiuchi
    • 9
  • Vinicius Rezende
    • 10
  • Dafang Zhong
    • 11
  1. 1.Pfizer, PDM-NBEPearl RiverUSA
  2. 2.Roche Pharma Research and Early Development, Pharmaceutical Sciences, Global DMPK and Bioanalytical R&DRoche Innovation Center New YorkNew YorkUSA
  3. 3.R&D CentreAlkem Laboratories Ltd.MumbaiIndia
  4. 4.Department of BioanalysisJanssen R&DBeerseBelgium
  5. 5.Novartis Institutes for Biomedical Research, Drug Metabolism and PharmacokineticsEast HanvoverUSA
  6. 6.Bio-Evaluation CenterTorrent Pharmaceutical Ltd.GandhinagarIndia
  7. 7.Analytical Biochemical Laboratory BVAssenThe Netherlands
  8. 8.Merck Research Laboratories, PPDMWest PointUSA
  9. 9.SCAS-BTT Bioanalysis Company Ltd.Cheongwon-gunSouth Korea
  10. 10.Department of Hematology, School of MedicineUniversity of Sao PauloSao PauloBrazil
  11. 11.Chinese Academy of SciencesShanghai Institute of Materia MedicaShanghaiChina
  12. 12.Pfizer R&DPearl RiverUSA

Personalised recommendations