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Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision making / / Filip Mussen, Sam Salek, Stuart Walker
| Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision making / / Filip Mussen, Sam Salek, Stuart Walker |
| Autore | Mussen Filip |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 |
| Descrizione fisica | 1 online resource (306 p.) |
| Disciplina |
615.19
615/.1901 |
| Altri autori (Persone) |
SalekSam
WalkerStuart R. <1944-> |
| Soggetto topico |
Drugs - Testing
Pharmaceutical policy - Decision making |
| ISBN |
1-282-25949-0
9786612259494 0-470-74811-7 0-470-74812-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Benefit-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
1.9 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 3.4 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 5.6 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 Appendix 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) Appendix 4 Commentaries on 'A Quantitative Approach to Benefit-risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16 |
| Record Nr. | UNINA-9910139929703321 |
Mussen Filip
|
||
| Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker
| Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker |
| Autore | Mussen Filip |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 |
| Descrizione fisica | 1 online resource (306 p.) |
| Disciplina |
615.19
615/.1901 |
| Altri autori (Persone) |
SalekSam
WalkerStuart R. <1944-> |
| Soggetto topico |
Drugs - Testing
Pharmaceutical policy - Decision making |
| ISBN |
1-282-25949-0
9786612259494 0-470-74811-7 0-470-74812-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Benefit-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
1.9 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 3.4 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 5.6 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 Appendix 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) Appendix 4 Commentaries on 'A Quantitative Approach to Benefit-risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16 |
| Record Nr. | UNINA-9910643711703321 |
|
Mussen Filip
|
||
| Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker
| Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker |
| Autore | Mussen Filip |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 |
| Descrizione fisica | 1 online resource (306 p.) |
| Disciplina |
615.19
615/.1901 |
| Altri autori (Persone) |
SalekSam
WalkerStuart R. <1944-> |
| Soggetto topico |
Drugs - Testing
Pharmaceutical policy - Decision making |
| ISBN |
1-282-25949-0
9786612259494 0-470-74811-7 0-470-74812-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Benefit-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
1.9 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 3.4 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 5.6 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 Appendix 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) Appendix 4 Commentaries on 'A Quantitative Approach to Benefit-risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16 |
| Record Nr. | UNINA-9910830138703321 |
|
Mussen Filip
|
||
| Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker
| Benefit-risk appraisal of medicines [[electronic resource] ] : a systematic approach to decision-making / / Filip Mussen, Sam Salek, Stuart Walker |
| Autore | Mussen Filip |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 |
| Descrizione fisica | 1 online resource (306 p.) |
| Disciplina |
615.19
615/.1901 |
| Altri autori (Persone) |
SalekSam
WalkerStuart R. <1944-> |
| Soggetto topico |
Drugs - Testing
Pharmaceutical policy - Decision making |
| ISBN |
1-282-25949-0
9786612259494 0-470-74811-7 0-470-74812-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Benefit-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
1.9 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 3.4 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 5.6 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 Appendix 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) Appendix 4 Commentaries on 'A Quantitative Approach to Benefit-risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16 |
| Record Nr. | UNINA-9910841543203321 |
|
Mussen Filip
|
||
| Chichester, West Sussex, UK ; ; Hoboken, NJ, : John Wiley & Sons, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||