Produktbild: Pharmacovigilance

Pharmacovigilance A Practical Approach

101,99 €

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Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

06.03.2025

Herausgeber

Thao Doan + weitere

Verlag

Elsevier

Seitenzahl

260

Maße (L/B/H)

23,6/19,1/1 cm

Gewicht

458 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-0-443-11881-4

Beschreibung

Portrait

Thao Doan is 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 isVice 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, United States.

Linda Scarazzini is Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, United States.

Charles Schubert is former Vice President, Oncology, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, United States.

Barbara Hendrickson is Clinical Associate, Department of Pediatrics, University of Chicago, Chicago, IL, United States

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

06.03.2025

Herausgeber

Verlag

Elsevier

Seitenzahl

260

Maße (L/B/H)

23,6/19,1/1 cm

Gewicht

458 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-0-443-11881-4

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: gpsr@libri.de

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  • Produktbild: Pharmacovigilance
  • 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