title: Biomarkers for pharmacogenetic and pharmacogenomic studies: Locking down analytical performance.
abstract: The use of in vitro tests to detect and measure biomarkers provides promising avenues for development of new and better drugs, and will be central to the realization of personalized medicine. The importance of proper biomarker test assessment cannot be overemphasized. Whether the test is being used as part of drug development or ultimately used as a companion diagnostic, if the test result is to be meaningful, the test analytical performance must be well characterized. This article will outline important analytical validation issues to consider when developing and assessing an in vitro diagnostic test system for use in pharmacogenetic and pharmacogenomic studies.:
authors: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA. Electronic address:Elizabeth.Mansfield@fda.hhs.gov.
authors: Elizabeth
authors: E
authors: Mansfield
authors: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.
authors: Zivana
authors: Z
authors: Tezak
authors: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.
authors: Sousan
authors: S
authors: Altaie
authors: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.
authors: Kathleen
authors: K
authors: Simon
authors: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.
authors: Steven
authors: S
authors: Gutman