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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
Opac: Controlla la disponibilità qui
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
Opac: Controlla la disponibilità qui
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
Opac: Controlla la disponibilità qui
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
Opac: Controlla la disponibilità qui
Benefit-Risk Assessment of Medicines [[electronic resource] ] : The Development and Application of a Universal Framework for Decision-Making and Effective Communication / / by James Leong, Sam Salek, Stuart Walker
Benefit-Risk Assessment of Medicines [[electronic resource] ] : The Development and Application of a Universal Framework for Decision-Making and Effective Communication / / by James Leong, Sam Salek, Stuart Walker
Autore Leong James
Edizione [1st ed. 2015.]
Pubbl/distr/stampa Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015
Descrizione fisica 1 online resource (326 p.)
Disciplina 306
353998
610
Soggetto topico Pharmacy
Medical research
Drug Safety and Pharmacovigilance
Quality of Life Research
ISBN 3-319-15805-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Prologue -- Preface -- Overview -- Approaches to utilising decision-making framework -- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities -- Development of a universal benefit-risk framework and template -- Implementation of the benefit-risk assessment template by mature agencies -- Implementation of the benefit- risk summary template by a maturing agency: A case study -- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada -- Conclusions and future directions -- References.
Record Nr. UNINA-9910300234003321
Leong James  
Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Living with Chronic Disease: Measuring Important Patient-Reported Outcomes [[electronic resource] /] / by Paul Kamudoni, Nutjaree Johns, Sam Salek
Living with Chronic Disease: Measuring Important Patient-Reported Outcomes [[electronic resource] /] / by Paul Kamudoni, Nutjaree Johns, Sam Salek
Autore Kamudoni Paul
Edizione [1st ed. 2018.]
Pubbl/distr/stampa Singapore : , : Springer Singapore : , : Imprint : Adis, , 2018
Descrizione fisica 1 online resource (170 pages)
Disciplina 338.473621
Soggetto topico Medical research
Quality of Life Research
ISBN 981-10-8414-9
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 1. Overview -- 2. Approaches to the Development and Use of PROs: A Unified Framework -- 3. An Illustration of the New PRO Measure Development Roadmap Using an Example from Skin Disease -- 4. Determination of Fitness for Purpose: Content Verification by Patients and Experts -- 5. Conventional Methods Meeting Modern Techniques: Factor Analysis Versus Rasch Analysis -- 6. Assessing the Performance of PROs Against Expectation: Psychometric Calibration -- 7. Integrating Patient Reported Outcomes in Clinical Trials, Routine Clinical Practice and Medicines Development Programmes.
Record Nr. UNINA-9910300265903321
Kamudoni Paul  
Singapore : , : Springer Singapore : , : Imprint : Adis, , 2018
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Pharmaceutical ethics [[electronic resource] /] / edited by Sam Salek, Andrew Edgar
Pharmaceutical ethics [[electronic resource] /] / edited by Sam Salek, Andrew Edgar
Pubbl/distr/stampa New York, : J. Wiley, c2002
Descrizione fisica 1 online resource (212 p.)
Disciplina 174.2
174/.2
Altri autori (Persone) SalekSam
EdgarAndrew
Soggetto topico Pharmaceutical ethics
Medical ethics
Soggetto genere / forma Electronic books.
ISBN 1-280-04371-7
9786610043712
0-470-35320-1
0-470-85581-9
0-470-85582-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Pharmaceutical Ethics; Contents; List of Contributors; Preface; Foreword; 1 The Basis of Ethics; 2 Principles of Ethics Focusing on the Patient; 3 Ethical Rationalism Applied to Pharmaceuticals; 4 The Ethics of the Drug Discovery and Development Process; 5 Informed Consent: Reconsideration of its Structure and Role in Medicine; 6 Clinical Trials of Pharmaceuticals: Ethical Aspects; 7 Can we Afford the Medicines we Need: An Ethical Dilemma?; 8 Physician Choice or Patient Choice: Ethical Dilemmas in Science and Politics
9 The Economics of Drug-Related Morbidity and Mortality: Ethical Considerations10 Holistic Approach in Choice of Pharmaceutical Agents: Ethical Responsibilities; 11 Ethical Values in the Treatment of Depression and Anxiety; 12 Ethical Promotion and Advertising of Medicines: Where do we Draw the Line?; 13 Ethical Problems of Drug Categorization for Reimbursement; Index
Record Nr. UNINA-9910142495803321
New York, : J. Wiley, c2002
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Pharmaceutical ethics [[electronic resource] /] / edited by Sam Salek, Andrew Edgar
Pharmaceutical ethics [[electronic resource] /] / edited by Sam Salek, Andrew Edgar
Pubbl/distr/stampa New York, : J. Wiley, c2002
Descrizione fisica 1 online resource (212 p.)
Disciplina 174.2
174/.2
Altri autori (Persone) SalekSam
EdgarAndrew
Soggetto topico Pharmaceutical ethics
Medical ethics
ISBN 1-280-04371-7
9786610043712
0-470-35320-1
0-470-85581-9
0-470-85582-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Pharmaceutical Ethics; Contents; List of Contributors; Preface; Foreword; 1 The Basis of Ethics; 2 Principles of Ethics Focusing on the Patient; 3 Ethical Rationalism Applied to Pharmaceuticals; 4 The Ethics of the Drug Discovery and Development Process; 5 Informed Consent: Reconsideration of its Structure and Role in Medicine; 6 Clinical Trials of Pharmaceuticals: Ethical Aspects; 7 Can we Afford the Medicines we Need: An Ethical Dilemma?; 8 Physician Choice or Patient Choice: Ethical Dilemmas in Science and Politics
9 The Economics of Drug-Related Morbidity and Mortality: Ethical Considerations10 Holistic Approach in Choice of Pharmaceutical Agents: Ethical Responsibilities; 11 Ethical Values in the Treatment of Depression and Anxiety; 12 Ethical Promotion and Advertising of Medicines: Where do we Draw the Line?; 13 Ethical Problems of Drug Categorization for Reimbursement; Index
Record Nr. UNINA-9910830068103321
New York, : J. Wiley, c2002
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Pharmaceutical ethics [[electronic resource] /] / edited by Sam Salek, Andrew Edgar
Pharmaceutical ethics [[electronic resource] /] / edited by Sam Salek, Andrew Edgar
Pubbl/distr/stampa New York, : J. Wiley, c2002
Descrizione fisica 1 online resource (212 p.)
Disciplina 174.2
174/.2
Altri autori (Persone) SalekSam
EdgarAndrew
Soggetto topico Pharmaceutical ethics
Medical ethics
ISBN 1-280-04371-7
9786610043712
0-470-35320-1
0-470-85581-9
0-470-85582-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Pharmaceutical Ethics; Contents; List of Contributors; Preface; Foreword; 1 The Basis of Ethics; 2 Principles of Ethics Focusing on the Patient; 3 Ethical Rationalism Applied to Pharmaceuticals; 4 The Ethics of the Drug Discovery and Development Process; 5 Informed Consent: Reconsideration of its Structure and Role in Medicine; 6 Clinical Trials of Pharmaceuticals: Ethical Aspects; 7 Can we Afford the Medicines we Need: An Ethical Dilemma?; 8 Physician Choice or Patient Choice: Ethical Dilemmas in Science and Politics
9 The Economics of Drug-Related Morbidity and Mortality: Ethical Considerations10 Holistic Approach in Choice of Pharmaceutical Agents: Ethical Responsibilities; 11 Ethical Values in the Treatment of Depression and Anxiety; 12 Ethical Promotion and Advertising of Medicines: Where do we Draw the Line?; 13 Ethical Problems of Drug Categorization for Reimbursement; Index
Record Nr. UNINA-9910840694103321
New York, : J. Wiley, c2002
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Pharmaceutical Regulatory Environment [[electronic resource] ] : Challenges and Opportunities in the Gulf Region / / by Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
Pharmaceutical Regulatory Environment [[electronic resource] ] : Challenges and Opportunities in the Gulf Region / / by Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
Autore Al-Essa Reem K
Edizione [1st ed. 2015.]
Pubbl/distr/stampa Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015
Descrizione fisica 1 online resource (246 p.)
Disciplina 610
613
614
615.1
Soggetto topico Public health
Pharmacotherapy
Public Health
ISBN 3-319-17590-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 1. Overview of Medicines Regulatory Systems in the Gulf Region -- 2. The Regulatory Review Process in the Gulf Region -- 3. Regulatory Review Times in the Gulf Region -- 4. Quality Measures in the Gulf Regulatory Practices -- 5. The Current Status of the Common Technical Document -- 6. The Current Status of Drug Safety and Pharmacovigilance -- 7. The Centralized Regulatory Review in the Gulf Region -- 8. The Gulf States Assessment and Experience With the Centralised Procedure -- 9. The Pharmaceutical Companies Assessment and Experience With the Centralised Procedure -- 10. Proposal For an Improved Centralized Regulatory System -- 11. The Strategic Planning Process of the GCC Regulatory Authorities: Barriers And Solutions -- 12. The Regulatory Dilemma in the Gulf Region: The Way Forward.
Record Nr. UNINA-9910300213903321
Al-Essa Reem K  
Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui