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Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design
| Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
| Descrizione fisica | 1 online resource (876 p.) |
| Disciplina | 363.19/463 |
| Soggetto topico |
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions Internationality Pharmacoepidemiology Product Surveillance, Postmarketing |
| ISBN |
1-118-82018-5
1-118-82014-2 1-118-82017-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title page; Copyright page; Contents; Contributors; Foreword; 1: Introduction: Updated from Second Edition; Background; Diagnosing Adverse Drug Reactions; Current Methods of Pharmacovigilance; Hypothesis-Generating Methods; Spontaneous Adverse Drug Reaction Reporting; Prescription-Event Monitoring; Other Hypothesis-Generating Methods; Hypothesis-Testing Methods; Conclusion; References; 2: History of Pharmacovigilance; Early History of Drug Safety; Recent History; Pre-1962; Turning Point: The Federal Food, Drug and Cosmetics Act; Gradual Increase in Regulatory Authority
Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation; United States of America; United Kingdom; Germany; Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of Pharmacovigilance; 3: Legal Basis: European Union; Introduction; Reorganization of the European Union Regulatory System Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management; Reporting Requirements; Transparency and Communication; Pharmacovigilance Enforcement; Further Information about Proposed New Legislation and Guidelines; 4: Ethical Oversight, Consent, and Confidentiality; Introduction; Practical Implications of Ethical Oversight; The Privacy and Security of Health Data; The Linkage of Electronic Health Data; The Conduct of Scientifically Sound Studies; Ethical Oversight and Privacy Law and Resulting Dilemmas; The Common Rule State LawsThe Health Insurance Portability and Accountability Act; Dilemmas Arising from the Health Insurance Portability and Accountability Act; Directions for Future Ethical Oversight and Privacy Provisions; References; 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1; Introduction; The International Conference on Harmonisation Step Process; ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations; ICH Step 2: Confirmation of Six Party Consensus; ICH Step 3: Regulatory Consultation ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations; Pharmacovigilance-Related International Conference on Harmonisation Topics; Topic ICH-E2A: Clinical Safety Data Management - Definitions and Standards for Expedited Reporting; ICH-E2D Topic: Post-Approval Safety Management - Definitions and Standards for Expedited Reporting; ICH-E2B Topic: Clinical Safety Data Management - Data Elements for Transmission of Individual Case Safety Reports ICH-E2C Topic: Clinical Safety Data Management - Periodic Benefit-Risk Evaluation Report (PBRER) |
| Record Nr. | UNINA-9910139125403321 |
| Chichester, England : , : Wiley Blackwell, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design
| Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
| Descrizione fisica | 1 online resource (876 p.) |
| Disciplina | 363.19/463 |
| Soggetto topico |
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions Internationality Pharmacoepidemiology Product Surveillance, Postmarketing |
| ISBN |
1-118-82018-5
1-118-82014-2 1-118-82017-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title page; Copyright page; Contents; Contributors; Foreword; 1: Introduction: Updated from Second Edition; Background; Diagnosing Adverse Drug Reactions; Current Methods of Pharmacovigilance; Hypothesis-Generating Methods; Spontaneous Adverse Drug Reaction Reporting; Prescription-Event Monitoring; Other Hypothesis-Generating Methods; Hypothesis-Testing Methods; Conclusion; References; 2: History of Pharmacovigilance; Early History of Drug Safety; Recent History; Pre-1962; Turning Point: The Federal Food, Drug and Cosmetics Act; Gradual Increase in Regulatory Authority
Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation; United States of America; United Kingdom; Germany; Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of Pharmacovigilance; 3: Legal Basis: European Union; Introduction; Reorganization of the European Union Regulatory System Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management; Reporting Requirements; Transparency and Communication; Pharmacovigilance Enforcement; Further Information about Proposed New Legislation and Guidelines; 4: Ethical Oversight, Consent, and Confidentiality; Introduction; Practical Implications of Ethical Oversight; The Privacy and Security of Health Data; The Linkage of Electronic Health Data; The Conduct of Scientifically Sound Studies; Ethical Oversight and Privacy Law and Resulting Dilemmas; The Common Rule State LawsThe Health Insurance Portability and Accountability Act; Dilemmas Arising from the Health Insurance Portability and Accountability Act; Directions for Future Ethical Oversight and Privacy Provisions; References; 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1; Introduction; The International Conference on Harmonisation Step Process; ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations; ICH Step 2: Confirmation of Six Party Consensus; ICH Step 3: Regulatory Consultation ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations; Pharmacovigilance-Related International Conference on Harmonisation Topics; Topic ICH-E2A: Clinical Safety Data Management - Definitions and Standards for Expedited Reporting; ICH-E2D Topic: Post-Approval Safety Management - Definitions and Standards for Expedited Reporting; ICH-E2B Topic: Clinical Safety Data Management - Data Elements for Transmission of Individual Case Safety Reports ICH-E2C Topic: Clinical Safety Data Management - Periodic Benefit-Risk Evaluation Report (PBRER) |
| Record Nr. | UNINA-9910813194203321 |
| Chichester, England : , : Wiley Blackwell, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmacovigilance / / editors, Ronald D. Mann, Elizabeth B. Andrews
| Pharmacovigilance / / editors, Ronald D. Mann, Elizabeth B. Andrews |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Chichester, West Sussex, England : , : Wiley, , 2007 |
| Descrizione fisica | 1 online resource (708 p.) |
| Disciplina |
363.19/463
615.1901 615.7 |
| Soggetto topico | Pharmacoepidemiology |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-83869-8
9786610838691 0-470-05921-4 0-470-05922-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Pharmacovigilance; Contents; Contributors; Preface; Foreword; Part I. The Basis of Pharmacovigilance; 1. Introduction; 2. Legal Basis - EU; 3. Legal Basis - United States; 4. Ethical Oversight, Consent and Confidentiality; 5. Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation; 6. Periodic Safety Update Reports; 7. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials; 8. Mechanisms of Adverse Drug Reactions; 9. Micturin and Torsades de Pointes; 10. Withdrawal of Terodiline: A Tale of Two Toxicities
11. Nomifensine and Haemolytic AnaemiaPart II. Signal Generation; 12. WHO Programme - Global Monitoring; 13. Medical Dictionary for Regulatory Activities (MedDRA®); 14. Regulatory Pharmacovigilance in the EU; 15. Spontaneous Reporting - UK; 16. Spontaneous Reporting - France; 17. Spontaneous Reporting in Germany; 18. Spontaneous Reporting - United States; 19. Statistical Methods of Signal Detection; 20. Statistical Methods of Evaluating Pharmacovigilance Data; 21. Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre; 22. Pharmacovigilance in the Netherlands 23. CIOMS Working Groups and their Contribution to Pharmacovigilance24. PEM in the UK; 25. PEM in New Zealand; 26. MEMO in the United Kingdom; 27. The General Practice Research Database: Now and the Future; 28. Overview of North American Databases; 29. Other Databases in Europe for the Analytic Evaluation of Drug Effects; 30. Surveillance for Medical Devices - USA; 31. Pharmacovigilance and Risk Management in Japan; Part III. Pharmacovigilance and Selected System Organ Classes; 32. Dermatological ADRs; 33. Gastrointestinal ADRs; 34. Haematological ADRs; 35. Hepatic ADRs 36. Ocular Side Effects of Prescription Medications37. Drug Safety in Pregnancy; 38. Renal Adverse Drug Reactions; 39. Anaesthetic Adverse Drug Reactions; 40. Pharmacovigilance in Pediatrics; 41. The Cardiovascular Spectrum of Adverse Drug Reactions; 42. Drugs and the Elderly; Part IV. Key Current Topics; 43. US Activities in Risk Management of Pharmaceutical Products; 44. Risk Management - a European Regulatory View; 45. The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents 46. Pharmacoepidemiology of Hormone Therapy: An Evolving Picture47. NSAIDs - COX-2 Inhibitors - Risks and Benefits; 48. Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences; Part V. Lessons and Directions; 49. Teaching and Learning Pharmacovigilance; 49b. Practical Experience in Teaching Pharmacovigilance; 50. Fatal Medication Errors and Adverse Drug Reactions - Coroners' Inquests and Other Sources; 51. Pharmacogenetics and the Genetic Basis of ADRs 52. Keynote Clinical Lessons from Pharmacovigilance |
| Record Nr. | UNINA-9910143731603321 |
| Chichester, West Sussex, England : , : Wiley, , 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmacovigilance / / editors, Ronald D. Mann, Elizabeth B. Andrews
| Pharmacovigilance / / editors, Ronald D. Mann, Elizabeth B. Andrews |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Chichester, West Sussex, England : , : Wiley, , 2007 |
| Descrizione fisica | 1 online resource (708 p.) |
| Disciplina |
363.19/463
615.1901 615.7 |
| Soggetto topico | Pharmacoepidemiology |
| ISBN |
1-280-83869-8
9786610838691 0-470-05921-4 0-470-05922-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Pharmacovigilance; Contents; Contributors; Preface; Foreword; Part I. The Basis of Pharmacovigilance; 1. Introduction; 2. Legal Basis - EU; 3. Legal Basis - United States; 4. Ethical Oversight, Consent and Confidentiality; 5. Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation; 6. Periodic Safety Update Reports; 7. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials; 8. Mechanisms of Adverse Drug Reactions; 9. Micturin and Torsades de Pointes; 10. Withdrawal of Terodiline: A Tale of Two Toxicities
11. Nomifensine and Haemolytic AnaemiaPart II. Signal Generation; 12. WHO Programme - Global Monitoring; 13. Medical Dictionary for Regulatory Activities (MedDRA®); 14. Regulatory Pharmacovigilance in the EU; 15. Spontaneous Reporting - UK; 16. Spontaneous Reporting - France; 17. Spontaneous Reporting in Germany; 18. Spontaneous Reporting - United States; 19. Statistical Methods of Signal Detection; 20. Statistical Methods of Evaluating Pharmacovigilance Data; 21. Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre; 22. Pharmacovigilance in the Netherlands 23. CIOMS Working Groups and their Contribution to Pharmacovigilance24. PEM in the UK; 25. PEM in New Zealand; 26. MEMO in the United Kingdom; 27. The General Practice Research Database: Now and the Future; 28. Overview of North American Databases; 29. Other Databases in Europe for the Analytic Evaluation of Drug Effects; 30. Surveillance for Medical Devices - USA; 31. Pharmacovigilance and Risk Management in Japan; Part III. Pharmacovigilance and Selected System Organ Classes; 32. Dermatological ADRs; 33. Gastrointestinal ADRs; 34. Haematological ADRs; 35. Hepatic ADRs 36. Ocular Side Effects of Prescription Medications37. Drug Safety in Pregnancy; 38. Renal Adverse Drug Reactions; 39. Anaesthetic Adverse Drug Reactions; 40. Pharmacovigilance in Pediatrics; 41. The Cardiovascular Spectrum of Adverse Drug Reactions; 42. Drugs and the Elderly; Part IV. Key Current Topics; 43. US Activities in Risk Management of Pharmaceutical Products; 44. Risk Management - a European Regulatory View; 45. The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents 46. Pharmacoepidemiology of Hormone Therapy: An Evolving Picture47. NSAIDs - COX-2 Inhibitors - Risks and Benefits; 48. Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences; Part V. Lessons and Directions; 49. Teaching and Learning Pharmacovigilance; 49b. Practical Experience in Teaching Pharmacovigilance; 50. Fatal Medication Errors and Adverse Drug Reactions - Coroners' Inquests and Other Sources; 51. Pharmacogenetics and the Genetic Basis of ADRs 52. Keynote Clinical Lessons from Pharmacovigilance |
| Record Nr. | UNINA-9910830084503321 |
| Chichester, West Sussex, England : , : Wiley, , 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||