Pharmacogenomic data: FDA voluntary and required submission guidance.

Abstract

PharmacogenomicsVol. 5, No. 5 Special ReportPharmacogenomic data: FDA voluntary and required submission guidanceRonald A Salerno, Lawrence J LeskoRonald A SalernoWorldwide Regulatory Affairs, Wyeth Research, Collegeville, PA 19426, USA. salernr@wyeth.comSearch for more papers by this author, Lawrence J LeskoOffice of Clinical Pharmacology and Biopharmaceutics, CDER, FDA, Maryland, USASearch for more papers by this authorPublished Online:5 Nov 2004https://doi.org/10.1517/14622416.5.5.503AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit FiguresReferencesRelatedDetailsCited ByBiomarkersPersonalized Medicine in Vascular Medicine2 February 2015Personalized Medicine Basic Principles18 February 2014Future Perspectives15 March 2013Impact of the Pharmaceutical Sciences on Health Care: A Reflection over the Past 50 YearsJournal of Pharmaceutical Sciences, Vol. 101, No. 11Ubiquitin-Mediated Proteasomal Degradation of ABC Transporters: a New Aspect of Genetic Polymorphisms and Clinical ImpactsJournal of Pharmaceutical Sciences, Vol. 100, No. 9Current Omics Technologies in Biomarker DiscoveryEmerging New Technologies in Pharamcogenomics: Rapid SNP detection, molecular dynamic simulation, and QSAR analysis methods to validate clinically important genetic variants of human ABC Transporter ABCB1 (P-gp/MDR1)Pharmacology & Therapeutics, Vol. 126, No. 1Rapid and cost-effective SNP detection method: application of SmartAmp2 to pharmacogenomics researchYasumasa Mitani, Alexander Lezhava, Aki Sakurai, Akina Horikawa, Makoto Nagakura, Yoshihide Hayashizaki & Toshihisa Ishikawa15 July 2009 | Pharmacogenomics, Vol. 10, No. 7The future (or lack of future) of personalized prescription in psychiatryPharmacological Research, Vol. 59, No. 2BiomarkersPharmacogenomics: The Promise of Personalized Medicine for CNS Disorders17 September 2008 | Neuropsychopharmacology, Vol. 34, No. 1Application of Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Review28 February 2013Validation of Analytic Methods for Biomarkers Used in Drug Development30 September 2008 | Clinical Cancer Research, Vol. 14, No. 19Metabolomics: a tool for personalizing medicine?Laura K Schnackenberg, Jim Kaput & Richard D Beger9 September 2008 | Personalized Medicine, Vol. 5, No. 5Pharmacogenomics and Personalized MedicineChapter 22 Pharmacogenomics for forensic toxicology in enabling personalized medicineIncorporating Pharmacogenomics into Practice30 June 2016 | Journal of Pharmacy Practice, Vol. 20, No. 3Overview of Sources of New DrugsA regulatory perspective on in vitro diagnosticsNature Biotechnology, Vol. 24, No. 8Process map proposal for the validation of genomic biomarkersFederico Goodsaid & Felix Frueh3 August 2006 | Pharmacogenomics, Vol. 7, No. 5Designing prospective clinical pharmacogenomic (PG) trials: meeting report on drug development strategies to enhance therapeutic decision making10 January 2006 | The Pharmacogenomics Journal, Vol. 6, No. 2Application of Pharmacogenomics in Clinical Pharmacology9 October 2008 | Toxicology Mechanisms and Methods, Vol. 16, No. 2-3Tests pharmacogénétiques : leur place en pratique médicale courante et dans le développement des médicamentsBulletin de l'Académie Nationale de Médecine, Vol. 190, No. 1Genetic polymorphisms of ATP-binding cassette transporters ABCB1 and ABCG2: therapeutic implications31 October 2005 | Expert Opinion on Pharmacotherapy, Vol. 6, No. 14Pharmacogenomics of the human ABC transporter ABCG2: from functional evaluation to drug molecular design14 September 2005 | Naturwissenschaften, Vol. 92, No. 10Regulatory Perspectives on Pharmacogenomics17 December 2009Pharmacogenomics: bench to bedsideNature Reviews Drug Discovery, Vol. 3, No. 9Translation of pharmacogenomics and pharmacogenetics: a regulatory perspectiveNature Reviews Drug Discovery, Vol. 3, No. 9Guest Editorial: Regulatory Acceptance of Toxicogenomics DataEnvironmental Health Perspectives, Vol. 112, No. 12Pharmacogenomic data submissions to the FDA: non-clinical case studiesJohn K Leighton, Joseph DeGeorge, David Jacobson-Kram, James MacGregor, Donna Mendrick, Alexandra Worobec5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomic data submissions to the FDA: clinical pharmacology case studiesGualberto Ruaño, Jerry M Collins, Andrew J Dorner, Sue-Jane Wang, Roberto Guerciolini, Shiew-Mei Huang5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomic data submissions to the FDA: clinical case studiesWilliam L Trepicchio, Grant A Williams, David Essayan, Sue T Hall, Lea C Harty, Peter M Shaw, Brian B Spear, Sue Jane Wang, Mark L Watson5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Current Omics Technologies in Biomarker Discovery Vol. 5, No. 5 Follow us on social media for the latest updates Metrics Downloaded 1,055 times History Published online 5 November 2004 Published in print July 2004 PDF download