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Implementation of Immunohistochemistry Assays for Clinical Trial Sample Analyses

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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))

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Abstract

Immunohistochemistry (IHC) is an essential tool for visualization and assessment of protein expression in sections of tissue in the context of sample morphology. IHC is utilized in preclinical applications to determine target engagement and pharmacodynamics, as well as proof of concept studies. However, transitioning an assay from the preclinical stage to implementation for human clinical trial sample analyses can be challenging for a number of reasons. For example, correlation of preclinical results on surrogate tissues may not be indicative of the final results in humans and assay conditions and reagents may need to be changed for optimal use on human formalin-fixed paraffin-embedded (FFPE) tissue. In clinical trials, IHC can be deployed to address different types of biomarker needs, such as for prospective patient enrollment where the assay validated to stringent clinical laboratory standards, or as a research assay used solely to generate observational data. Using a chromogen-based oncology IHC biomarker analyses as an example, this chapter will cover a range of considerations for implementation of IHC assays in clinical trials, from sample collection considerations through assay validation and implementation.

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Author information

Authors and Affiliations

  1. Translational Biomakers, Merck & Co., Rahway, NJ, USA

    Marisa Dolled-Filhart, Usha Singh, Dianna Wu & K. Emancipator

Authors
  1. Marisa Dolled-Filhart
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  2. Usha Singh
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  3. Dianna Wu
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  4. K. Emancipator
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Corresponding author

Correspondence to Marisa Dolled-Filhart .

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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Dolled-Filhart, M., Singh, U., Wu, D., Emancipator, K. (2016). Implementation of Immunohistochemistry Assays for Clinical Trial Sample Analyses. 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_16

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