Evidence-Based Pharmacovigilance

Clinical and Quantitative Aspects

  • Andrew Bate

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

Table of contents

  1. Front Matter
    Pages i-xv
  2. Eugène van Puijenbroek
    Pages 1-16
  3. Anthony P. Grillo, Frederick W. Fraunfelder
    Pages 17-35
  4. Marcus Schmitt-Egenolf
    Pages 149-164
  5. Linda Härmark
    Pages 165-183
  6. Haggar Hilda Ampadu, Yvonne Esseku, Alexander N. O. Dodoo
    Pages 185-199
  7. Yola Moride
    Pages 217-232
  8. Back Matter
    Pages 259-275

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.


Medicinal products Risk assessment PV research Safety in medication Pharmaceutical sciences

Editors and affiliations

  • Andrew Bate
    • 1
  1. 1.Epidemiology Group Lead, AnalyticsWorldwide Safety and RegulatoryTadworthUK

Bibliographic information

  • DOI
  • Copyright Information Springer Science+Business Media, LLC, part of Springer Nature 2018
  • Publisher Name Humana Press, New York, NY
  • eBook Packages Springer Protocols
  • Print ISBN 978-1-4939-8816-7
  • Online ISBN 978-1-4939-8818-1
  • Series Print ISSN 1557-2153
  • Series Online ISSN 1940-6053
  • Buy this book on publisher's site
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