SpringerProtocols: Abstract: 3. Quality Control of Microarray Assays for Toxicogenomic and In Vitro Diagnostic Applications

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

By: Karol L. Thompson⁴, Joseph Hackett⁵

Abstract

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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.

Affiliation(s): (4) Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
(5) Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland

Book Title: Essential Concepts in Toxicogenomics

Series: Methods in Molecular Biology | Volume: 460 | Pub. Date: Oct-01-2008 | Page Range: 45-68 | DOI: 10.1007/978-1-60327-048-9_3

Subject: Pharmacology/Toxicology

Key Words: in vitro diagnostics - metrics - microarrays - quality control - standards

References

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