Pharmacovigilance
edited by Ron Mann

Pharmacovigilance is a single reference detailing the issues and current status of the necessity, safety, and effectiveness of pharmaceuticals today.

Pharmacovigilance is clearly structured and covers all the important areas of the subject including:

• legal aspects
• drug regulatory requirements
• methods of signal generation
• reporting schemes
• pharmacovigilance in selected system-organ classes
• future directions

Contents:

1. Basis of Pharmacovigilance
   1. Introduction
   2. Legal Basis - EU
   3. Legal Basis - US
   4. Ethical Oversight, Consent and Confidentiality
   5. Preclinical Safety Evaluation
   6. Metabolic Mechanisms
   7. Drugs and the Elderly
   8. Natural History
   9. Responding to Signals
   10. Micturin and Torsades de Pointes
   11. Withdrawal of Terodiline: A Tale of Two Toxicities
   12. Nomifensine and Haemolytic Anaemia

2. Signal Generation
   13. WHO Program - Global Monitoring
   14. Regulatory Pharmacovigilance in the EU
   15. Spontaneous Reporting - UK
   16. Spontaneous Reporting - France
   17. Spontaneous Reporting - USA
   18. Algorithms
   19. Overview - Spontaneous Signalling
   20. Statistical Methods of Signal Detection
   21. Statistical Methods of Evaluating Pharmacovigilance Data
   22. Data Mining
   23. Epidemiology of Adverse Events Associated with Epilepsy and Use of Lamotrigine
   24. Pharmacovigilance in the Netherlands
   25. CIOMS Working Groups and their Contribution to Pharmacovigilance
   26. PEM in the UK
   27. PEM in New Zealand
   28. MEMO in the UK
   29. GPRD in the UK
   30. Overview of North American Databases
   31. Pharmacovigilance in the HMO Research Network
   32. Other Databases in Europe
   33. Surveillance for Medical Devices - USA

3. Pharmacovigilance and Selected System Organ Classes
   34. Dermatological ADRs
   35. Gastrointestinal ADRs
   36. Haematological ADRs
   37. Hepatic Adverse Drug Reactions
   38. Ocular ADRs
   39. Drug Safety in Pregnancy
   40. ADRs and Drug Safety 1999-2000

4. Lessons and Directions
   41. Teaching Pharmacovigilance
   42. Medical Errors and Lessons from Drug-Related Deaths
   43. Pharmacogenetics and the Genetic Basis of ADRs
   44. Keynote Clinical Lessons from Pharmacovigilance

Index

click here to see books of related interest

ORDER NOW Pharmacovigilance edited by Ron Mann 560 pages • $354.00 + shipping Texas residents please add 6.75 % sales tax