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Preanalytic Considerations for Molecular Genomic Analyses of Tissue

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Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

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Abstract

Progress in the era of molecular characterization of patients, diseases, and drugs, relies on access to clinical biospecimens characteristic of the general population and of patients with specific disease states to identify predictive and prognostic biomarkers for individualized therapeutic planning. Biospecimens properly consented for clinical research can be difficult to obtain and often are quite limited in volume and mass, making it incumbent on clinical investigators to use these resources effectively to maximize the learning that comes from their analysis. This includes careful documentation of the specimens themselves along with preservation methods and storage planning to support the study objectives. In addition, careful experimental planning focused on the molecules that will be analyzed and commitment to assuring laboratory processes and methods have been fully developed and pre-tested using nonessential, representative biospecimens as surrogates for the intended study specimens are necessary. Following these steps will result in high yields of the best quality data and will ensure interpretable results that will contribute to advancing knowledge of disease states and applicable therapeutic options.

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  1. Strategic Information Management, Celgene Corporation, 1500 Owens Street, Suite 600, San Francisco, CA, 94158, USA

    Maureen Cronin

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  1. Maureen Cronin
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Correspondence to Maureen Cronin .

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  1. Flagship Biosciences, LLC, Westminster, Colorado, USA

    Steven J. Potts

  2. University of North Carolina, Chapel Hill, North Carolina, USA

    David A. Eberhard

  3. Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA

    Keith A. Wharton, Jr.

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Cronin, M. (2014). Preanalytic Considerations for Molecular Genomic Analyses of Tissue. In: Potts, S., Eberhard, D., Wharton, Jr., K. (eds) Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/7653_2014_17

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  • DOI: https://doi.org/10.1007/7653_2014_17

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-2680-0

  • Online ISBN: 978-1-4939-2681-7

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