Pharmacovigilance

Thao Doan is Group Medical Director, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Department of Pharmacology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA Fabio Lievano isVice President, Patient Safety, Scientific Collaborations, and New Business Advancement, Pharmacovigilance and Patient Safety, Epidemiology and, R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Northwestern University Feinberg School of Medicine, Chicago, IL, United States. Linda Scarazzini is Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, United States. Charles Schubert is former Vice President, Oncology, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, United States. Barbara Hendrickson is Clinical Associate, Department of Pediatrics, University of Chicago, Chicago, IL, United States

"The text serves to provide a comprehensive overview of preclinical drug development and the regulatory process while intertwining ongoing monitoring for drug-related adverse events.... The breadth of expertise and experience of the authors offers significant insights and makes this book an appropriate text for training professionals within the pharmacovigilance field.... The writing is consistent from chapter to chapter despite the variety of authors writing each section,... uses visual images to demonstrate concepts for easier comprehensibility and adds summary boxes within each chapter to provide a brief overview. The illustrations and diagrams are clear, easy to read, and intuitively placed throughout each chapter to prevent overwhelming readers.... provides a great degree of detail relating to all aspects of pharmacovigilance, covering pre-clinical safety management, signal and risk management, and first-in-human trials while also addressing special populations and integration information technology.... Overall, for individuals training within pharmacovigilance or interested in learning more about a field, this book is strongly recommended as it provides an excellent, comprehensive structured review of the field." Review by Vasyl Zbyrak, PharmD (Temple University School of Pharmacy), ©Doody's Review Service, 2025.

• SECTION 1 THE REGULATORY ENVIRONMENT AND THE PHARMACOVIGILANCE QUALITY SYSTEM1. Does Regulation Drive Science or Does Science Drive Regulation?SECTION 2 PRECLINICAL SAFETY ASSESSMENT2. Absorption, Distribution, Metabolism and Excretion, Pharmacokinetics, and Safety Pharmacology3. Preclinical Safety Assessment : General and Genetic Toxicology4. PharmacogeneticsSECTION 3 FIRST-IN-HUMAN TRIALS5. Safety Planning for First-in-Human Trials6. Pharmacokinetic and Pharmacodynamic Considerations in Safety EvaluationSECTION 4 SAFETY ASSESSMENT IN CLINICAL TRIALS7. Safety Monitoring in Clinical Trials8. Introduction to Quantitative Methods and Visual Analytics in Drug Safety Data in Clinical Trials9. Product Aggregate Safety Assessment10. Data Monitoring CommitteesSECTION 5 SIGNAL AND RISK MANAGEMENT11. Methods of Signal Detection and Signal Management12. Causality Assessment13. Examples of Adverse Drug Reactions: Drug-Induced Liver Injury, Renal, Skin, Immune-Mediated Events, and Major Adverse Cardiac Events14. Internal Safety Advisory Groups15. Benefit-Risk ManagementSECTION 6 ROLE OF EPIDEMIOLOGY AND REALWORLD EVIDENCE16. Role of Epidemiology and Pharmacoepidemiology in the Biopharmaceutical Industry17. Real-World Pharmacoepidemiology StudiesSECTION 7 SPECIAL POPULATIONS AND SPECIAL TOPICS18. Pharmacovigilance in Pregnancy19. Pharmacovigilance in Pediatrics20. Pharmacovigilance in the Elderly21. Vaccine Pharmacovigilance22. Application of Human Factors and Health Literacy in Pharmacovigilance23. Medical Device Safety Oversight and SurveillanceSECTION 8 THE NEXT FRONTIER24. Information Technology in Pharmacovigilance: Current State and Future Directions25. The Future of Pharmacovigilance