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Liquid Chromatography–Mass Spectrometry Assays in the Regulated Bioanalytical Laboratory

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Regulated Bioanalysis: Fundamentals and Practice

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 26))

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Abstract

Data derived from robust and reproducible bioanalytical assays form the foundation of all pharmaceutical marketing approval submissions to regulatory agencies. In this chapter, bioanalytical method development, validation, and sample analysis for small molecules are discussed with emphasis on high performance liquid chromatography–mass spectrometry/mass spectrometry (LC–MS/MS) assays. Considerations for assay development include selection of analyte extraction, chromatography, and mass spectrometry parameters. Relevant aspects of validation testing and documentation are covered. Sample analysis for both good laboratory practice (animal, nonclinical) and good clinical practice (human, clinical) studies is discussed. Regulatory compliance issues are addressed for assay development, validation, and sample analysis.

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Author information

Authors and Affiliations

  1. Covance Laboratories, Inc., 3301 Kinsman Blvd, Madison, WI 53704, USA

    Stephanie S. Cape & Mohammad R. Koupaei-Abyazani

  2. Covance Laboratories, Inc., 1121 East 3900 South, Salt Lake City, UT 84124, USA

    Min Meng

  3. Covance Laboratories, Inc., 109 Paradise Court, De Forest, WI 53532, USA

    Douglas M. Fast

Authors
  1. Stephanie S. Cape
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  2. Min Meng
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  3. Mohammad R. Koupaei-Abyazani
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  4. Douglas M. Fast
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Corresponding author

Correspondence to Stephanie S. Cape .

Editor information

Editors and Affiliations

  1. Laboratory Services, ICON, Plc, Whitesboro, New York, USA

    Mario L. Rocci Jr.

  2. Bioanalytical and ADME Labs, Q Squared Solutions, Ithaca, New York, USA

    Stephen Lowes

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© 2017 American Association of Pharmaceutical Scientists

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Cape, S.S., Meng, M., Koupaei-Abyazani, M.R., Fast, D.M. (2017). Liquid Chromatography–Mass Spectrometry Assays in the Regulated Bioanalytical Laboratory. In: Rocci Jr., M., Lowes, S. (eds) Regulated Bioanalysis: Fundamentals and Practice. AAPS Advances in the Pharmaceutical Sciences Series, vol 26. Springer, Cham. https://doi.org/10.1007/978-3-319-54802-9_7

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