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The Role of Commercial Biomarker Assay Kits in Preclinical and Clinical Trials

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Translating Molecular Biomarkers into Clinical Assays

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 21))

Abstract

The aim of this chapter is to discuss the role of commercial assay kits when quantitatively measuring biomarkers to support preclinical and clinical drug development programs. Research use only and clinical diagnostic kits will be compared and their usefulness addressed in the context of the 2013 FDA draft guidance on bioanalytical method validation. Analytical method performance characteristics will be discussed as well as mechanisms to generate consistent biomarker data throughout the life of the study.

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Abbreviations

Biomarker:

A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic response to a therapeutic intervention

Definitive Quantitative Assay:

Uses calibrators fit to a regression model to calculate the absolute quantitative values for unknown samples and the reference standards are well defined and fully representative of the endogenous biomarker

Bioanalytical Method Validation:

A formal process of evaluating the analytical performance characteristics of an assay to ensure it provides reliable data

Research Use Only kits:

Commercial assay reagents and components intended to be used to generate research quality data

Clinical Diagnostic Kits:

FDA approved reagents and components intended to be used for the diagnosis of human disease and medical risk factors

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Author information

Authors and Affiliations

  1. Radix BioSolutions, 111 Cooperative Way, Ste 120, Georgetown, TX, 78660, USA

    William Nowatzke

  2. B2S Consulting, 6656 Flowstone Way, Indianapolis, IN, 46237, USA

    Ronald R. Bowsher

Authors
  1. William Nowatzke
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  2. Ronald R. Bowsher
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Corresponding author

Correspondence to William Nowatzke .

Editor information

Editors and Affiliations

  1. Translational Biomarkers and Personalized Medicine, Edison, New Jersey, USA

    Russell Weiner

  2. MKelley Consulting LLC, West Chester, Pennsylvania, USA

    Marian Kelley

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© 2016 American Association of Pharmaceutical Scientists

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Nowatzke, W., Bowsher, R.R. (2016). The Role of Commercial Biomarker Assay Kits in Preclinical and Clinical Trials. In: Weiner, R., Kelley, M. (eds) Translating Molecular Biomarkers into Clinical Assays . AAPS Advances in the Pharmaceutical Sciences Series, vol 21. Springer, Cham. https://doi.org/10.1007/978-3-319-40793-7_8

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