Description
Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance: A Practical Approach, 2nd 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.- 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.- Any additional digital ancillary content may publish up to 6 weeks following the publication date.·Re-organized and expanded with 3 new sections and 9 new chapters covering pre-clinical safety assessment, pharmacogenetics, first-in human trials, product aggregate safety assessment, and data monitoring committees.·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.
Table of Contents
1 Does Regulation Drive Science or Does Science Drive Regulation?2 Absorption, Distribution, Metabolism and Excretion, Pharmacokinetics, and Safety Pharmacology3 Preclinical Safety Assessment : General and Genetic Toxicology4 Pharmacogenetics5 Safety Planning for First-in-Human Trials6 Pharmacokinetic and Pharmacodynamic Considerations in Safety Evaluation7 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 Committees11 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 Management16 Role of Epidemiology and Pharmacoepidemiology in the Biopharmaceutical Industry17 Real-World Pharmacoepidemiology Studies18 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 Surveillance24 Information Technology in Pharmacovigilance: Current State and Future Directions25 The Future of Pharmacovigilance
