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Evidence-Based Pharmacovigilance

Clinical and Quantitative Aspects

  • Book
  • © 2018

Overview

Editors:
  1. Andrew Bate

    1. Epidemiology Group Lead, Analytics, Worldwide Safety and Regulatory, Tadworth, UK

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  • Provides an array of methods that strive to ever more effectively protect patients from medicine-related harm
  • Covers both clinical and quantitative aspects of Pharmacovigilance
  • Explores how areas in the field may develop in the future

Part of the book series: Methods in Pharmacology and Toxicology (MIPT)

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Table of contents (13 protocols)

  1. Front Matter

    Pages i-xv
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  2. Congenital Malformations

    • Eugène van Puijenbroek
    Pages 1-16

  3. Pharmacovigilance and the Eye

    • Anthony P. Grillo, Frederick W. Fraunfelder
    Pages 17-35

  4. Pharmacovigilance of Herbal and Traditional Medicines

    • Li Zhang
    Pages 37-65

  5. Pediatric Pharmacovigilance: Current Practice and Future Perspectives

    • Lise Aagaard
    Pages 67-85

  6. Detecting Safety Issues in Clinical Trials

    • Emma Heeley
    Pages 87-103

  7. Developments and Future Directions of Prescription-Based Observational Cohort Pharmacovigilance

    • Deborah Layton
    Pages 105-134

  8. Electronic Health Record, Transactional Insurance Claims, and Distributed Databases in Pharmacovigilance

    • Kevin Haynes
    Pages 135-148

  9. Patient Registries for Safetyness

    • Marcus Schmitt-Egenolf
    Pages 149-164

  10. Patient Reported Outcomes in Pharmacovigilance

    • Linda Härmark
    Pages 165-183

  11. Evidence-Based Pharmacovigilance for Medicines Used in Public Health Programs in Africa

    • Haggar Hilda Ampadu, Yvonne Esseku, Alexander N. O. Dodoo
    Pages 185-199

  12. Pharmacoepidemiological Approaches for Population-Based Hypothesis Testing

    • Olaf H. Klungel
    Pages 201-216

  13. Risk Management and Minimization

    • Yola Moride
    Pages 217-232

  14. Benefit-Risk Assessment in Pharmacovigilance

    • Ola Caster
    Pages 233-257

  15. Back Matter

    Pages 259-275
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Keywords

About this book

This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment.

Vital and authoritative, Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance with a strong sense that there is much more work to be done in ensuring the safe use of medications by patients.

Editors and Affiliations

  • Epidemiology Group Lead, Analytics, Worldwide Safety and Regulatory, Tadworth, UK

    Andrew Bate

Bibliographic Information

  • Book Title: Evidence-Based Pharmacovigilance

  • Book Subtitle: Clinical and Quantitative Aspects

  • Editors: Andrew Bate

  • Series Title: Methods in Pharmacology and Toxicology

  • DOI: https://doi.org/10.1007/978-1-4939-8818-1

  • Publisher: Humana New York, NY

  • eBook Packages: Springer Protocols

  • Copyright Information: Springer Science+Business Media, LLC, part of Springer Nature 2018

  • Hardcover ISBN: 978-1-4939-8816-7Published: 26 October 2018

  • eBook ISBN: 978-1-4939-8818-1Published: 25 October 2018

  • Series ISSN: 1557-2153

  • Series E-ISSN: 1940-6053

  • Edition Number: 1

  • Number of Pages: XV, 275

  • Number of Illustrations: 9 b/w illustrations, 27 illustrations in colour

  • Topics: Pharmacology/Toxicology

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