LEADER 02815nam 2200649Ia 450 001 9910456008503321 005 20200520144314.0 010 $a0-309-51372-3 035 $a(CKB)110986584753192 035 $a(EBL)3375925 035 $a(SSID)ssj0000560469 035 $a(PQKBManifestationID)12176889 035 $a(PQKBTitleCode)TC0000560469 035 $a(PQKBWorkID)10576248 035 $a(PQKB)10098832 035 $a(SSID)ssj0000279143 035 $a(PQKBManifestationID)11223022 035 $a(PQKBTitleCode)TC0000279143 035 $a(PQKBWorkID)10260027 035 $a(PQKB)10943532 035 $a(MiAaPQ)EBC3375925 035 $a(Au-PeEL)EBL3375925 035 $a(CaPaEBR)ebr10051610 035 $a(OCoLC)940510198 035 $a(EXLCZ)99110986584753192 100 $a20001116d2000 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aEnhancing data systems to improve the quality of cancer care$b[electronic resource] /$fMaria Hewitt and Joseph V. Simone, editors ; National Cancer Policy Board, Institute of Medicine and Commission on Life Sciences, National Research Council 210 $aWashington, D.C. $cNational Academy Press$d2000 215 $a1 online resource (175 p.) 300 $aDescription based upon print version of record. 311 $a0-309-08649-3 311 $a0-309-07191-7 320 $aIncludes bibliographical references and index. 327 $aFront Matter; Acknowledgments; Contents; Executive Summary; 1 Introduction; 2 What Would an Ideal Cancer Care Data System Look Like?; 3 How Are Healthcare Systems Monitoring Quality Today?; 4 The Data Infrastructure for Health Services Research; 5 Status of the Cancer Care Data System; 6 Findings and Recommendations; References; Acronyms and Abbreviations; APPENDIX A Ensuring Quality Cancer Care: Report Summary; APPENDIX B Workshop Agenda and Participants; APPENDIX C Summary of Selected Registry-Based Quality Studies; APPENDIX D Information on Cancer Registries, by State 327 $aAPPENDIX E Reporting Requirements, NPCR, NCDB, SEER,Index 606 $aCancer$xTreatment 606 $aInformation storage and retrieval systems$xOncology 606 $aMedical care$xQuality control 608 $aElectronic books. 615 0$aCancer$xTreatment. 615 0$aInformation storage and retrieval systems$xOncology. 615 0$aMedical care$xQuality control. 676 $a362.1/96994 701 $aHewitt$b Maria Elizabeth$0876922 701 $aSimone$b Joseph V$0895415 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910456008503321 996 $aEnhancing data systems to improve the quality of cancer care$92000358 997 $aUNINA LEADER 01013cam a22002778a 4500 001 991000165809707536 008 090406s2007 njua b 001 0 eng d 020 $a9780691125053 (hbk.) 020 $a0691125058 (hbk.) 035 $ab13821647-39ule_inst 040 $aDip.to Fisica$beng 082 04$a539.7$222 084 $aLC QC776 084 $a53.4 100 1 $aBertulani, Carlos A.$0496573 245 10$aNuclear physics in a nutshell /$cCarlos Bertulani 260 $aPrinceton, N.J. ;$aWoodstock :$bPrinceton University Press,$cc2007 300 $axiii, 473 p. :$bill. ;$c26 cm 504 $aIncludes bibliographical references (p. [461]-467) and index 650 0$aNuclear physics 907 $a.b13821647$b28-01-14$c06-04-09 912 $a991000165809707536 945 $aLE006 53.4 BER$g1$i2006000162883$lle006$op$pE49.52$q-$rl$s- $t0$u3$v0$w3$x0$y.i1495087x$z06-04-09 996 $aNuclear physics in a nutshell$91225256 997 $aUNISALENTO 998 $ale006$b06-04-09$cm$da $e-$feng$gnju$h0$i0 LEADER 05364nam 2200649Ia 450 001 9910830138703321 005 20230216042743.0 010 $a1-282-25949-0 010 $a9786612259494 010 $a0-470-74811-7 010 $a0-470-74812-5 035 $a(CKB)1000000000794233 035 $a(EBL)454324 035 $a(SSID)ssj0000289819 035 $a(PQKBManifestationID)11222066 035 $a(PQKBTitleCode)TC0000289819 035 $a(PQKBWorkID)10402077 035 $a(PQKB)10272164 035 $a(MiAaPQ)EBC454324 035 $a(OCoLC)463430920 035 $a(PPN)240451635 035 $a(EXLCZ)991000000000794233 100 $a20090507d2009 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aBenefit-risk appraisal of medicines$b[electronic resource] $ea systematic approach to decision-making /$fFilip Mussen, Sam Salek, Stuart Walker 210 $aChichester, West Sussex, UK ;$aHoboken, NJ $cJohn Wiley & Sons$d2009 215 $a1 online resource (306 p.) 300 $aDescription based upon print version of record. 311 $a0-470-06085-9 320 $aIncludes bibliographical references and index. 327 $aBenefit-Risk Appraisal of Medicines; Contents; Foreword; Preface; 1 Concept and Scope of Benefit-Risk Evaluation of Medicines; 1.1 Historical background; 1.2 The regulatory systems for assessing medicines; 1.3 Benefit-risk assessment: definitions; 1.4 Views and perceptions of benefits and risks of medicines; 1.5 Stages and concepts in benefit-risk assessment; 1.6 Benefit-risk assessment: the current regulatory environment; 1.7 Benefit-risk assessment in other disciplines; 1.8 Specific methods and models for benefit-risk assessment 327 $a1.9 Discussions with stakeholders on the concepts and models for benefit-risk evaluation2 Criteria for a Benefit-Risk Model: a Conceptual Framework; 2.1 Introduction; 2.2 Regulatory guidelines on benefit and risk criteria; 2.3 Identification, definition and rationale of relevant benefit and risk criteria; 2.4 Verification of the list of benefit and risk criteria by means of a survey; 3 Review of the Current Benefit-Risk Assessment Models; 3.1 Background; 3.2 Evaluation of the existing benefit-risk assessment models; 3.3 Review of models in single clinical trials and for specific medicines 327 $a3.4 Conclusion3.5 Newer models; 4 Defining a Systematic Approach to Decision Making; 4.1 Introduction; 4.2 Objectives and features of the ideal model for benefit-risk assessment; 4.3 The use of decision-analysis techniques for the development of the new model; 5 Development and Application of a Benefit-Risk Assessment Model Based on Multi-Criteria Decision Analysis; 5.1 Introduction; 5.2 Conceptualization of the new model; 5.3 Reasons for using decision analysis techniques in the new model; 5.4 The use of MCDA in the new model; 5.5 Development of the new model 327 $a5.6 Applicability of the new model5.7 Summary; 5.8 Review of the MCDA model; 6 A Future Framework for Benefit-Risk Appraisal of Medicines; 6.1 Background; 6.2 Development of a benefit-risk framework for regulatory review of new medicines; 6.3 Prerequisites of a benefit-risk framework for the registration of a new medicine; 6.4 Current status of benefit-risk assessment among companies and agencies; 6.5 Constructing a benefit-risk framework; 6.6 Conclusion; Appendices 327 $aAppendix 1 Summary Reports of the CMR International Institute for Regulatory Science March 2004 and June 2005 Workshops on Benefit-RiskAppendix 2 Office of Health Economics Briefing: Challenges and Opportunities for Improving Benefit-risk Assessment of Pharmaceuticals from an Economic Perspective - James Cross and Louis Garrison (August 2008); Appendix 3 Reflection Paper on Benefit-risk Assessment Methods in the Context of the Evaluation of Marketing Authorisation Applications of Medicinal Products for Human Use - Committee for Medicinal Products for Human Use (March 2008) 327 $aAppendix 4 Commentaries on 'A Quantitative Approach to Benefit-risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16 330 $aBenefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, 606 $aDrugs$xTesting 606 $aPharmaceutical policy$xDecision making 615 0$aDrugs$xTesting. 615 0$aPharmaceutical policy$xDecision making. 676 $a615.19 676 $a615/.1901 700 $aMussen$b Filip$01640960 701 $aSalek$b Sam$0787913 701 $aWalker$b Stuart R.$f1944-$01640961 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910830138703321 996 $aBenefit-risk appraisal of medicines$93984754 997 $aUNINA