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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 | ||
| ||
Benefit-Risk Assessment of Medicines : 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 : 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 | ||
| ||
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 | ||
| ||
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 | ||
| ||
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 | ||
| ||
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 | ||
| ||
Pharmaceutical Regulatory Environment : Challenges and Opportunities in the Gulf Region / / by Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
| Pharmaceutical Regulatory Environment : 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 | ||
| ||