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Quality Control of Microarray Assays for Toxicogenomic and In Vitro Diagnostic Applications

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Essential Concepts in Toxicogenomics

Part of the book series: Methods in Molecular Biology™ ((MIMB,volume 460))

Summary

The generation of high-quality microarray data for toxicogenomics can be affected by the study design and methods used for sample acquisition, preparation, and processing. Bias can be introduced during animal treatment, tissue handling, and sample preparation. Metrics and controls used in assessing RNA integrity and the quality of microarray sample generation are reviewed in this chapter. Regulations and guidelines involved in the application of microarrays as a commercial in vitro diagnostic device are also described.

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Acknowledgment

This article represents the professional opinions and statements of the authors and is not an official document, guidance, or policy of the U.S. Government, Department of Health and Human Services (DHHS), or the FDA, nor should any official endorsement be inferred.

Author information

Authors and Affiliations

  1. Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland

    Karol L. Thompson

  2. Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland

    Joseph Hackett

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  1. Karol L. Thompson
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  2. Joseph Hackett
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Editors and Affiliations

  1. Gene Logic Inc, Gaithersburg, MD, USA

    Donna L. Mendrick

  2. The Critical Path Institute, Rockville, MD, USA

    William B. Mattes

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© 2008 Humana Press, a part of Springer Science+Business Media, LLC

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Thompson, K.L., Hackett, J. (2008). Quality Control of Microarray Assays for Toxicogenomic and In Vitro Diagnostic Applications. In: Mendrick, D.L., Mattes, W.B. (eds) Essential Concepts in Toxicogenomics. Methods in Molecular Biology™, vol 460. Humana Press. https://doi.org/10.1007/978-1-60327-048-9_3

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  • DOI: https://doi.org/10.1007/978-1-60327-048-9_3

  • Publisher Name: Humana Press

  • Print ISBN: 978-1-58829-638-2

  • Online ISBN: 978-1-60327-048-9

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