Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects

ISBN-13: 9781493988167 / Angielski / Twarda / 2018 / 275 str.

Andrew Bate

Spis treści

1. Congenital Malformations

            Eugène van Puijenbroek

 

2. Pharmacovigilance and the Eye

            Anthony P. Grillo and Frederick W. Fraunfelder

 

3. Pharmacovigilance of Herbal and Traditional Medicines

            Li Zhang

 

4. Pediatric Pharmacovigilance: Current Practice and Future Perspectives

            Lise Aagaard

 

5. Detecting Safety Issues in Clinical Trials

            Emma Heeley

 

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

            Deborah Layton

 

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

            Kevin Haynes

 

8. Patient Registries for Safetyness

            Marcus Schmitt-Egenolf

 

9. Patient-Reported Outcomes in Pharmacovigilance

            Linda Härmark

 

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

            Haggar Hilda Ampadu, Yvonne Esseku, and Alexander N.O. Dodoo

 

11. Pharmacoepidemiological Approaches for Population-Based Hypothesis Testing

            Olaf H. Klungel

 

12. Risk Management and Minimization

            Yola Moride

 

13. Benefit-Risk Assessment in Pharmacovigilance

            Ola Caster

 

Concluding Thoughts

            Andrew Bate

Blurb

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.