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Clinical Application of Molecular Features in Therapeutic Selection and Drug Development

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Statistical Methods in Biomarker and Early Clinical Development

Abstract

The previous chapter (“Validation of Genomic-Based Assay”) introduced general methodologies on biomarkers evaluation for clinical utility and analytical validity, with an illustrating example of BRAF V600E for both aspects. In this chapter, we focus on a specific type of biomarkers: the ones useful for therapeutic decision and therapeutic drug development in the clinical setting.

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Acknowledgment

We thank Giulia C. Kennedy, Marla Johnson, Steven Shak, Frederick Baehner, James Whitmore, Jennifer Duke, Barry Grobman, and Bethann Hromatka for their valuable input and critical review for the chapter.

Author information

Authors and Affiliations

  1. Genomic Health, Inc., Fremont, CA, USA

    Ruixiao Lu

  2. Servier Pharmaceuticals, Boston, MA, USA

    Rui Tang

  3. Veracyte Inc., South San Francisco, CA, USA

    Jing Huang

Authors
  1. Ruixiao Lu
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  2. Rui Tang
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  3. Jing Huang
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Editor information

Editors and Affiliations

  1. MyoKardia Inc., South San Francisco, CA, USA

    Liang Fang

  2. BioMarin Pharmaceutical Inc., San Rafael, CA, USA

    Cheng Su

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Lu, R., Tang, R., Huang, J. (2019). Clinical Application of Molecular Features in Therapeutic Selection and Drug Development. In: Fang, L., Su, C. (eds) Statistical Methods in Biomarker and Early Clinical Development. Springer, Cham. https://doi.org/10.1007/978-3-030-31503-0_8

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