01523nam0 22003253i 450 SBL030059320251003044351.0IT835755 19910930d1983 ||||0itac50 baitaitz01i xxxe z01nz01ncRDAcarrierChiesa e comunità politicaGuido SaraceniMilanoA. Giuffrè1983XVI, 295 p.25 cm.Chiesa cattolica romanaPotere temporaleFIRLO1C243153I262.13ECCLESIOLOGIA. PAPATO E PATRIARCATO21262.132PAPI E PATRIARCHI. POTERE TEMPORALE22Saraceni, Guido <1909-2004>CFIV037509070229095ITIT-00000019910930IT-BN0095 NAP 01D $NAP 01POZZO LIB.Vi sono collocati fondi di economia, periodici di ingegneria e scienze, periodici di economia e statistica e altri fondi comprendenti documenti di economia pervenuti in dono. SBL0300593Biblioteca Centralizzata di Ateneo 01D (AR) 29 851 01AR 0700298515 VMA (bis 1 v. (2. copia)Y 20131030201310301 v.1 v. 01POZZO LIB.ECON MON 4726 01C 0008008025E VMA 1 v. (Precedente collocazione: EC C 000 802)B 2013030420130304 01Chiesa e comunità politica66941UNISANNIO04666nam 2200673 a 450 991096410150332120251017110111.00-309-17817-71-281-30023-397866113002340-309-11013-0(CKB)1000000000714260(SSID)ssj0000279034(PQKBManifestationID)11210640(PQKBTitleCode)TC0000279034(PQKBWorkID)10259467(PQKB)10930698(MiAaPQ)EBC3378332(Au-PeEL)EBL3378332(CaPaEBR)ebr10225174(CaONFJC)MIL130023(OCoLC)923278378(DNLM)1480922(BIP)53859402(BIP)21539219(EXLCZ)99100000000071426020080623d2008 uy 0engurcn|||||||||txtccrEmerging safety science workshop summary /Sally 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 Academies1st ed.Washington, D.C. National Academies Pressc2008xvi, 134 p. ill. (some col.)Workshop held April 23-24, 2007 in Silver Spring, MD.0-309-11012-2 Includes bibliographical references (p. 115-116).Front 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.In 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.DrugsUnited StatesSafety measuresCongressesPharmaceutical biotechnologyUnited StatesCongressesDrugsUnited StatesDesignCongressesDrugsSafety measuresPharmaceutical biotechnologyDrugsDesign615/.10289Robinson Sally620917Pool Robert288454Giffin Robert B1806072Institute of Medicine (U.S.).Forum on Drug Discovery, Development, and Translation.MiAaPQMiAaPQMiAaPQBOOK9910964101503321Emerging safety science4447371UNINA