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Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation

  • Commentary
  • Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium
  • Published:
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Abstract

The continued globalization of pharmaceutics has increased the demand for companies to know and understand the regulations that exist across the globe. One hurdle facing pharmaceutical and biotechnology companies developing new drug candidates is interpreting the current regulatory guidance documents and industry publications associated with bioanalytical method validation (BMV) from each of the different agencies throughout the world. The objective of this commentary is to provide our opinions on the best practices for reference standards and key reagents, such as metabolites and internal standards used in the support of regulated bioanalysis based on a review of current regulatory guidance documents and industry white papers for BMV.

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Author information

Authors and Affiliations

  1. Covance Laboratories Inc., 3635 Concorde Parkway, Suite 100, Chantilly, Virginia, 20151, USA

    Joseph F. Bower

  2. PPD, 2244 Dabney Road, Richmond, Virginia, 23230, USA

    Jennifer B. McClung

  3. A4P Bioanalytical Group, Innovation House, Discovery Park, Sandwich, Kent, CT13 9 N, UK

    Carl Watson

  4. Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, Osaka, 540-0021, Japan

    Takahiko Osumi

  5. MAGABI Pesquisas Clínicas e Fa, Rodovia Presidente Castelo Branco Km 35, 6 Complexo Industrial, Bloco 9, Itapevi, SP, 06696-000, Brazil

    Kátia Pastre

Authors
  1. Joseph F. Bower
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  2. Jennifer B. McClung
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  3. Carl Watson
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  4. Takahiko Osumi
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  5. Kátia Pastre
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Corresponding author

Correspondence to Joseph F. Bower.

Additional information

Guest editors: Binodh DeSilva and Philip Timmerman

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Bower, J.F., McClung, J.B., Watson, C. et al. Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation. AAPS J 16, 352–356 (2014). https://doi.org/10.1208/s12248-014-9566-y

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  • DOI: https://doi.org/10.1208/s12248-014-9566-y

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