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 co
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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.
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
Author Information
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, 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
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, 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
https://www.asia.elsevierhealth.com/pharmacovigilance-9780443118814.html323406Pharmacovigilancehttps://www.asia.elsevierhealth.com/media/catalog/product/9/7/9780443118814_1.jpg89.9999.99USDInStock/Books/Coming soon5054664505466914886536Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, <i>Pharmacovigilance: A Practical Approach, Second Edition</i>, provides a <b>succinct, easy-to-digest overview</b> of an increasingly critical area of medical safety. From cover to cover, this concise resource offers <b>essential information for physicians and other health care professionals</b>, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance. Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, <i>Pharmacovigilance: A Practical Approach, Second Edition</i>, provides a <b>succinct, easy-to-digest overview</b> of an increasingly critical area of medical safety. From cover to cover, this concise resource offers <b>essential information for physicians and other health care professionals</b>, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.00add-to-cart97804431188142025ProfessionalEdited by Thao Doan, MD, Fabio Lievano, MD, PhD H.C., Linda Scarazzini, MD, Charles Schubert, MD, MPH and Barbara Hendrickson, MD20262Book191w x 235h (7.50" x 9.25")Elsevier0Mar 24, 2025COMING SOONEdited by <STRONG>Thao Doan</STRONG>, 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, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; <STRONG>Fabio Lievano</STRONG>, 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; <STRONG>Linda Scarazzini</STRONG>, MD, Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, USA; <STRONG>Charles Schubert</STRONG>, MD, MPH, Former Vice President, Oncology, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, USA and <STRONG>Barbara Hendrickson</STRONG>, MD, Clinical Associate, Department of Pediatrics, University of Chicago, Chicago, IL, USABooksBookUnited StatesYesYesNoNoPlease SelectPlease SelectPlease Select
