LEADER 05363nam 2200649Ia 450 001 9910139929703321 005 20170810173312.0 010 $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(OCoLC)463430920 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(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$0946832 701 $aSalek$b Sam$0787913 701 $aWalker$b Stuart R.$f1944-$0946833 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910139929703321 996 $aBenefit-risk appraisal of medicines$92139145 997 $aUNINA