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Repeat Analysis and Incurred Sample Reanalysis: 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

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.

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ACKNOWLEDGMENTS

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

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Authors and Affiliations

  1. Pfizer, PDM-NBE, Pearl River, New York, USA

    Eric Fluhler

  2. Roche Pharma Research and Early Development, Pharmaceutical Sciences, Global DMPK and Bioanalytical R&D, Roche Innovation Center New York, New York, New York, USA

    Faye Vazvaei

  3. R&D Centre, Alkem Laboratories Ltd., Mumbai, Maharashtra, India

    Puran Singhal

  4. Department of Bioanalysis, Janssen R&D, Beerse, Belgium

    Petra Vinck

  5. Novartis Institutes for Biomedical Research, Drug Metabolism and Pharmacokinetics, East Hanvover, New Jersey, USA

    Wenkui Li

  6. Bio-Evaluation Center, Torrent Pharmaceutical Ltd., Village-Bhat, Gandhinagar, Gujarat, India

    Jignesh Bhatt

  7. Analytical Biochemical Laboratory BV, AJ, , Assen, The Netherlands

    Theo de Boer

  8. Merck Research Laboratories, PPDM, West Point, Pennsylvania, USA

    Ajai Chaudhary

  9. SCAS-BTT Bioanalysis Company Ltd., Cheongwon-gun, Chungcheongbuk-do, South Korea

    Masahiro Tangiuchi

  10. Department of Hematology, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil

    Vinicius Rezende

  11. Chinese Academy of Sciences, Shanghai Institute of Materia Medica, Shanghai, China

    Dafang Zhong

  12. Pfizer R&D, Bldg. 200/3608A, 401N. Middletown Road, Pearl River, New York, 10992, USA

    Eric Fluhler

Authors
  1. Eric Fluhler
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  2. Faye Vazvaei
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  3. Puran Singhal
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  4. Petra Vinck
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  5. Wenkui Li
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  6. Jignesh Bhatt
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  7. Theo de Boer
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  8. Ajai Chaudhary
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  9. Masahiro Tangiuchi
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  10. Vinicius Rezende
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  11. Dafang Zhong
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Corresponding author

Correspondence to Eric Fluhler.

Additional information

Guest Editors: Binodh DeSilva and Philip Timmerman

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Fluhler, E., Vazvaei, F., Singhal, P. et al. Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team. AAPS J 16, 1167–1174 (2014). https://doi.org/10.1208/s12248-014-9644-1

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  • DOI: https://doi.org/10.1208/s12248-014-9644-1

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