LEADER 04666nam 2200673 a 450 001 9910964101503321 005 20251017110111.0 010 $a0-309-17817-7 010 $a1-281-30023-3 010 $a9786611300234 010 $a0-309-11013-0 035 $a(CKB)1000000000714260 035 $a(SSID)ssj0000279034 035 $a(PQKBManifestationID)11210640 035 $a(PQKBTitleCode)TC0000279034 035 $a(PQKBWorkID)10259467 035 $a(PQKB)10930698 035 $a(MiAaPQ)EBC3378332 035 $a(Au-PeEL)EBL3378332 035 $a(CaPaEBR)ebr10225174 035 $a(CaONFJC)MIL130023 035 $a(OCoLC)923278378 035 $a(DNLM)1480922 035 $a(BIP)53859402 035 $a(BIP)21539219 035 $a(EXLCZ)991000000000714260 100 $a20080623d2008 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aEmerging safety science $eworkshop summary /$fSally Robinson, Robert Pool, and Robert Giffin [rapporteurs] ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$dc2008 215 $axvi, 134 p. $cill. (some col.) 300 $aWorkshop held April 23-24, 2007 in Silver Spring, MD. 311 08$a0-309-11012-2 320 $aIncludes bibliographical references (p. 115-116). 327 $aFront Matter -- Reviewers -- Preface -- Contents -- Tables and Figures -- 1 Introduction -- 2 Investigative Toxicology: The State of the Art -- 3 Screening Technologies I: Human Cell-Based Approaches -- 4 Screening Technologies II: Toxicogenomics -- 5 Screening Technologies III: Metabolomics -- 6 Screening Technologies IV: Pharmacogenetics -- 7 Qualifying Biomarkers -- 8 Pharmacovigilance -- 9 Integration -- 10 The Future of Safety Science -- References -- Appendixes -- Appendix A: Workshop Agenda -- Appendix B: Speaker Biographies. 330 $aIn recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients. Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop. 606 $aDrugs$zUnited States$xSafety measures$vCongresses 606 $aPharmaceutical biotechnology$zUnited States$vCongresses 606 $aDrugs$zUnited States$xDesign$vCongresses 615 0$aDrugs$xSafety measures 615 0$aPharmaceutical biotechnology 615 0$aDrugs$xDesign 676 $a615/.10289 701 $aRobinson$b Sally$0620917 701 $aPool$b Robert$0288454 701 $aGiffin$b Robert B$01806072 712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910964101503321 996 $aEmerging safety science$94447371 997 $aUNINA