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All the chapters have been updated in this second edition and new chapters like Pharmacoepidemiology and Pharmacovigilance, Hospitalization due to Adverse Drug Reactions and its Economic Burden, and Vigilance Systems for Medical Devices have been added.This book will be useful for the healthcare professionals, postgraduate students, industry professionals and those engaged in clinical research at academia and the pharmaceutical industry.
SK Gupta PhD DSc FIPS FIACSSushma Srivastava PhD PDCR
1. Key Definitions in Pharmacovigilance2. Pharmacovigilance: Historical Perspective3. Pharmacovigilance: Need and Objectives4. Current Methods of Pharmacovigilance5. Adverse Drug Reactions: Classification, Mechanism and Interaction6. Signal Detection in Pharmacovigilance7. Postmarketing Surveillance8. Setting up of a Pharmacovigilance Centre9. Benefit-Risk Assessment in Pharmacovigilance10. Crisis Management in Pharmacovigilance11. WHO Pharmacovigilance: Programme for Global Drug Monitoring12. Pharmacovigilance of Herbal Drugs13. Medical Dictionary for Regulatory Activities: An Overview14. Pharmacogenetics and Pharmacovigilance15. Pharmacovigilance Regulations in Various Countries16. Pharmacoepidemiology and Pharmacovigilance17. Hospitalization due to Adverse Drug Reactions and its Economic Burden18. Vigilance Systems for Medical Devices19. Data Mangement in PharmacovigilanceAnnexuresIndex