Pharmacovigilance : a practical approach
Doan, Thao (Éditeur intellectuel) / Lievano, Fabio (Éditeur intellectuel) / Scarazzini, Linda (Éditeur intellectuel) / Schubert, Charles (Éditeur intellectuel) / Hendrickson, Barbara (Éditeur intellectuel) 1954-
2nd edition
2025
1 ressource en ligne
Format PDF
9780443118814
Anglais
1. Does Regulation Drive Science or Does Science Drive Regulation? -- 2. Absorption, Distribution, Metabolism and Excretion, Pharmacokinetics, and Safety Pharmacology -- 3. Preclinical Safety Assessment : General and Genetic Toxicology -- 4. Pharmacogenetics -- 5. Safety Planning for First-in-Human Trials -- 6. Pharmacokinetic and Pharmacodynamic Considerations in Safety Evaluation -- 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 -- 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 -- 16. Role of Epidemiology and Pharmacoepidemiology in the Biopharmaceutical Industry -- 17. Real-World Pharmacoepidemiology Studies -- 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 -- 24. Information Technology in Pharmacovigilance: Current State and Future Directions -- 25. The Future of Pharmacovigilance
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.