Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal

Abstract

PharmacogenomicsVol. 5, No. 1 Conference SceneFree AccessPharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) ProposalRonald A Salerno and Lawrence J LeskoRonald A SalernoDirector, Worldwide Regulatory Affairs, Wyeth Research, Collegeville, PA 19426, USA. Search for more papers by this authorEmail the corresponding author at Salernr@wyeth.com and Lawrence J LeskoDirector, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA, Maryland, USASearch for more papers by this authorPublished Online:28 Jan 2008https://doi.org/10.2217/14622416.5.1.25AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail FiguresReferencesRelatedDetailsCited ByRegulatory considerations for companion diagnostic devicesEunice Y Lee & Hsin-Chieh Jennifer Shen21 January 2015 | Biomarkers in Medicine, Vol. 9, No. 1Personalized Medicine in Vascular Medicine2 February 2015Personalized Medicine Basic Principles18 February 2014Pharmacogenomics in early-phase clinical developmentTal Burt & Savita Dhillon9 July 2013 | Pharmacogenomics, Vol. 14, No. 9Future Perspectives15 March 2013One Hundred Years of Drug Regulation: Where Do We Go from Here?Annual Review of Pharmacology and 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