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Pharmacovigilance

A Practical Approach

Specificaties
Paperback, blz. | Engels
Elsevier Health Sciences | 2025
ISBN13: 9780443118814
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Elsevier Health Sciences e druk, 2025 9780443118814
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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.Presents vital, easy-to-read, cutting-edge information on patient safety, the pharmacology regulatory landscape, and the current and future use of digital technologiesProvides 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 eventsContains new chapters on pre-clinical safety assessment, pharmacogenetics, first-in human trials, product aggregate safety assessment, data monitoring committees, and moreOffers 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 professionalsIncludes real-world case studies to ensure content is relevant and applicable to everyday practiceDiscusses a range of topics across disciplines and how they relate to pharmacovigilance, including behavioral science, patient perspectives, and risk communicationAn 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

Specificaties

ISBN13:9780443118814
Taal:Engels
Bindwijze:Paperback

Inhoudsopgave

SECTION 1 THE REGULATORY ENVIRONMENT AND THE PHARMACOVIGILANCE QUALITY SYSTEM<br>1. Does Regulation Drive Science or Does Science Drive Regulation?<br><br>SECTION 2 PRECLINICAL SAFETY ASSESSMENT<br>2. Absorption, Distribution, Metabolism and Excretion, Pharmacokinetics, and Safety Pharmacology<br>3. Preclinical Safety Assessment : General and Genetic Toxicology<br>4. Pharmacogenetics<br><br>SECTION 3 FIRST-IN-HUMAN TRIALS<br>5. Safety Planning for First-in-Human Trials<br>6. Pharmacokinetic and Pharmacodynamic Considerations in Safety Evaluation<br><br>SECTION 4 SAFETY ASSESSMENT IN CLINICAL TRIALS<br>7. Safety Monitoring in Clinical Trials<br>8. Introduction to Quantitative Methods and Visual Analytics in Drug Safety Data in Clinical Trials<br>9. Product Aggregate Safety Assessment<br>10. Data Monitoring Committees<br><br>SECTION 5 SIGNAL AND RISK MANAGEMENT<br>11. Methods of Signal Detection and Signal Management<br>12. Causality Assessment<br>13. Examples of Adverse Drug Reactions: Drug-Induced Liver Injury, Renal, Skin, Immune-Mediated Events, and Major Adverse Cardiac Events<br>14. Internal Safety Advisory Groups<br>15. Benefit–Risk Management<br><br>SECTION 6 ROLE OF EPIDEMIOLOGY AND REALWORLD EVIDENCE<br>16. Role of Epidemiology and Pharmacoepidemiology in the Biopharmaceutical Industry<br>17. Real-World Pharmacoepidemiology Studies<br><br>SECTION 7 SPECIAL POPULATIONS AND SPECIAL TOPICS<br>18. Pharmacovigilance in Pregnancy<br>19. Pharmacovigilance in Pediatrics<br>20. Pharmacovigilance in the Elderly<br>21. Vaccine Pharmacovigilance<br>22. Application of Human Factors and Health Literacy in Pharmacovigilance<br>23. Medical Device Safety Oversight and Surveillance<br><br>SECTION 8 THE NEXT FRONTIER<br>24. Information Technology in Pharmacovigilance: Current State and Future Directions<br>25. The Future of Pharmacovigilance
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        Pharmacovigilance