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Pharmacovigilance

Pharmacovigilance

A Practical Approach

9780443118814
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Description
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.
Product Details
Elsevier
103075
9780443118814
9780443118814

Data sheet

Publication date
2025
Issue number
2
Cover
paperback
Dimensions (mm)
191 x 235
Weight (g)
470
  • 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
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