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Pharmacovigilance,

Edition 2 A Practical Approach

Editors: Edited by Thao Doan, MD, Fabio Lievano, MD, PhD H.C., Linda Scarazzini, MD, Charles Schubert, MD, MPH and Barbara Hendrickson, MD

Publication Date: 06 Mar 2025

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**Selected for 2026 Doody's Core Titles in Pharmacy**

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.

Key Features

Presents vital, easy-to-read, cutting-edge information on patient safety, the pharmacology regulatory landscape, and the current and future use of digital technologies
Provides up-to-date coverage of hot topics in the field, including pharmacodynamic and safety precision medicine, immunogenicity, vaccine hesitancy and safety, genetic toxicology, and adverse events
Contains new chapters on pre-clinical safety assessment, pharmacogenetics, first-in human trials, product aggregate safety assessment, data monitoring committees, and more
Offers new and expanded coverage of pharmacovigilance in early pre-clinical drug development through post-marketing surveillance, as well as a blueprint for training future pharmacovigilance professionals
Includes real-world case studies to ensure content is relevant and applicable to everyday practice
Discusses a range of topics across disciplines and how they relate to pharmacovigilance, including behavioral science, patient perspectives, and risk communication
An eBook version is included with purchase. The eBook allows you to access all of the text, figures and references, with the ability to search, customize your content, make notes and highlights, and have content read aloud. Additional digital ancillary content may publish up to 6 weeks following the publication date

About the author

Edited by Thao Doan, MD, 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, MD, PhD H.C., Vice 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, USA; Linda Scarazzini, MD, Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, USA; Charles Schubert, MD, MPH, Former Vice President, Oncology, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, USA and Barbara Hendrickson, MD, Clinical Associate, Department of Pediatrics, University of Chicago, Chicago, IL, USA

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

Book Reviews

"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.