Pharmacovigilance / / editors, Ronald D. Mann, Elizabeth B. Andrews

• Pubblicazione: Chichester, West Sussex, England : , : Wiley, , 2007; ©2007
• Edizione: 2nd ed.
• Descrizione fisica: 1 online resource (708 p.)
• Disciplina: 363.19/463; 615.1901; 615.7
• Soggetto topico: Pharmacoepidemiology
• Persona (resp. second.): MannRonald D <1928-> (Ronald David); AndrewsElizabeth B.
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references at the end of each chapters and index.
• 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
• Sommario/riassunto: Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing within the pharmacovigilance communityThe tex
• Titolo autorizzato: Pharmacovigilance
• ISBN: 1-280-83869-8; 9786610838691; 0-470-05921-4; 0-470-05922-2
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910830084503321
• Lo trovi qui: Univ. Federico II