Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance:: A Practical Approach, Second Edition, provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. From cover to cover, this concise resource offers essential information for physicians and other health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
SECTION 1 THE REGULATORY ENVIRONMENT AND THE PHARMACOVIGILANCE QUALITY SYSTEM 1. Does Regulation Drive Science or Does Science Drive Regulation?
SECTION 2 PRECLINICAL SAFETY ASSESSMENT 2. Absorption, Distribution, Metabolism and Excretion, Pharmacokinetics, and Safety Pharmacology 3. Preclinical Safety Assessment : General and Genetic Toxicology 4. Pharmacogenetics
SECTION 3 FIRST-IN-HUMAN TRIALS 5. Safety Planning for First-in-Human Trials 6. Pharmacokinetic and Pharmacodynamic Considerations in Safety Evaluation
SECTION 4 SAFETY ASSESSMENT IN CLINICAL TRIALS 7. Safety Monitoring in Clinical Trials 8. Introduction to Quantitative Methods and Visual Analytics in Drug Safety Data in Clinical Trials 9. Product Aggregate Safety Assessment 10. Data Monitoring Committees
SECTION 5 SIGNAL AND RISK MANAGEMENT 11. Methods of Signal Detection and Signal Management 12. Causality Assessment 13. Examples of Adverse Drug Reactions: Drug-Induced Liver Injury, Renal, Skin, Immune-Mediated Events, and Major Adverse Cardiac Events 14. Internal Safety Advisory Groups 15. Benefit-Risk Management
SECTION 6 ROLE OF EPIDEMIOLOGY AND REALWORLD EVIDENCE 16. Role of Epidemiology and Pharmacoepidemiology in the Biopharmaceutical Industry 17. Real-World Pharmacoepidemiology Studies
SECTION 7 SPECIAL POPULATIONS AND SPECIAL TOPICS 18. Pharmacovigilance in Pregnancy 19. Pharmacovigilance in Pediatrics 20. Pharmacovigilance in the Elderly 21. Vaccine Pharmacovigilance 22. Application of Human Factors and Health Literacy in Pharmacovigilance 23. Medical Device Safety Oversight and Surveillance
SECTION 8 THE NEXT FRONTIER 24. Information Technology in Pharmacovigilance: Current State and Future Directions 25. The Future of Pharmacovigilance
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