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Validation and Control of Bioanalytical Methods

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Handbook of Anticancer Pharmacokinetics and Pharmacodynamics

Part of the book series: Cancer Drug Discovery and Development ((CDD&D))

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Abstract

The results of toxicokinetic, pharmacokinetic, and bioequivalence studies are used to make critical decisions regarding the safety and efficacy of anticancer drug substances. Therefore, measurement of anticancer drug concentrations in biological matrices is an important aspect in the development of these products. Such data are required by regulating agencies to support new drug applications as well as for line extensions and generic products of these drugs. It is therefore most essential to adequately characterize and fully validate the applied bioanalytical methods used in the determination of this class of compounds to ensure that they function in the manner in which they are intended. Since the release of the FDA prescribed Guidance for Industry in Bioanalytical Method Validation in May 2001, it is much clearer what is required for method validation. There are however a number of areas that are still not well developed in the FDA guidance, and the recently proposed draft European Medical Agency guidance addresses some of these. Apart from discussing acceptance criteria on the primary matrices required to determine bioanalytical assay suitability such as accuracy, precision, and selectivity, the draft guidance proposes additional criteria for other important aspects such stability tests, matrix effects, cross validation, and incurred sample reanalysis. The current chapter provides an overview of the current scientific approaches based on the literature while considering them in the context of these guidances in this highly regulated area.

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Author information

Authors and Affiliations

  1. Department of Pharmaceutics, Virginia Commonwealth University School of Pharmacy, 980533, Richmond, VA, 23298-0533, USA

    H. Thomas Karnes Ph.D.

  2. Research Scientist R&D, Chromatographic Sciences Department, PPD, 2244 Dabney Road, Richmond, Virginia, 23230, USA

    Kumar A. Shah Ph.D.

Authors
  1. H. Thomas Karnes Ph.D.
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  2. Kumar A. Shah Ph.D.
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Corresponding author

Correspondence to H. Thomas Karnes Ph.D. .

Editor information

Editors and Affiliations

  1. Sidney Kimmel Comprehensive Cancer Cente, Baltimore, Maryland, USA

    Michelle A. Rudek

  2. Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA

    Cindy H. Chau

  3. Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA

    William D. Figg

  4. Moffitt Cancer Center, Tampa, Florida, USA

    Howard L. McLeod

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Karnes, H.T., Shah, K.A. (2014). Validation and Control of Bioanalytical Methods. In: Rudek, M., Chau, C., Figg, W., McLeod, H. (eds) Handbook of Anticancer Pharmacokinetics and Pharmacodynamics. Cancer Drug Discovery and Development. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9135-4_8

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  • DOI: https://doi.org/10.1007/978-1-4614-9135-4_8

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  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-1-4614-9134-7

  • Online ISBN: 978-1-4614-9135-4

  • eBook Packages: MedicineMedicine (R0)

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