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Textbook of Pharmacoepidemiology

Textbook of Pharmacoepidemiology

Brian L. Strom (Editor), Stephen E. Kimmel (Editor)

ISBN: 978-1-118-70800-2

May 2013

520 pages



The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references.
  • One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price
  • Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies
  • Designed for students with basic knowledge of epidemiology and public health
  • Includes many case studies to illustrate pharmacoepidemiology in real clinical setting  
List of Contributors.



Acknowledgments from Pharmacoepidemiology, Fourth Edition.


1. What is Pharmacoepidemiology? (Brian L. Strom).

2. Study Designs Available for Pharmacoepidemiology Studies (Brian L. Strom).

3. Sample Size Considerations for Pharmacoepidemiology Studies (Brian L. Strom).

4. Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiology Studies (Sean Hennessy).

5. When Should One Perform Pharmacoepidemiology Studies? (Brian L. Strom).

6. Views from Academia, Industry, and Regulatory Agencies (Leanne K. Madre, Robert M. Califf, Robert F. Reynolds, Peter Arlett, and Jane Moseley).


7. Spontaneous Reporting in the United States (Syed Rizwanuddin Ahmad, Norman S. Marks, and Roger A. Goetsch).

8. Global Drug Surveillance: The WHO Programme for International Drug Monitoring (I. Ralph Edwards, Sten Olsson, Marie Lindquist, and Bruce Hugman).

9. Case–Control Surveillance (Lynn Rosenberg, Patricia F. Coogan, and Julie R. Palmer).

10. Prescription-Event Monitoring (Saad A.W. Shakir).

11. Overview of Automated Databases in Pharmacoepidemiology (Brian L. Strom).

12. Examples of Automated Databases (Andy Stergachis, Kathleen W. Saunders, Robert L. Davis, Stephen E. Kimmel, Rita Schinnar, K. Arnold Chan, Deborah Shatin, Nigel S.B. Rawson, Sean Hennessy, Winanne Downey, MaryRose Stang, Patricia Beck, William Osei, Hubert G. Leufkens, Thomas M. MacDonald, and Joel M. Gelfand).

13. Other Approaches to Pharmacoepidemiology Studies (Brian L. Strom).

14. How Should One Perform Pharmacoepidemiology Studies? Choosing Among the Available Alternatives (Brian L. Strom).

15. Validity of Pharmacoepidemiologic Drug and Diagnosis Data (Suzanne L. West, Brian L. Strom, and Charles Poole).


16. Bias and Confounding in Pharmacoepidemiology (Ilona Csizmadi and Jean-Paul Collet).

17. Determining Causation from Case Reports (Judith K. Jones).

18. Molecular Pharmacoepidemiology (Stephen E. Kimmel).

19. Bioethical Issues in Pharmacoepidemiologic Research (Kevin Haynes, Jason Karlawish, and Elizabeth B. Andrews).

20. The Use of Randomized Controlled Trials for Pharmacoepidemiology Studies (Samuel M. Lesko and Allen A. Mitchell).

21. The Use of Pharmacoepidemiology to Study Beneficial Drug Effects (Brian L. Strom).

22. Pharmacoeconomics: Economic Evaluation of Pharmaceuticals (Kevin A. Schulman, Henry A. Glick, and Daniel Polsky).

23. Using Quality-of-Life Measurements in Pharmacoepidemiologic Research (Holger Schünemann, Gordon H. Guyatt, and Roman Jaeschke).

24. The Use of Meta-analysis in Pharmacoepidemiology (Carin J. Kim and Jesse A. Berlin).

25. Patient Adherence to Prescribed Drug Dosing Regimens in Ambulatory Pharmacotherapy (John Urquhart and Bernard Vrijens).

26. Novel Approaches to Pharmacoepidemiology Study Design and Statistical Analysis (Samy Suissa).


27. Special Applications of Pharmacoepidemiology (David Lee, Sumit R. Majumdar, Helene Levens Lipton, Stephen B. Soumerai, Sean Hennessy, Robert L. Davis, Robert T. Chen, Roselie A. Bright, Allen A. Mitchell, David J. Graham, David W. Bates, and Brian L. Strom).

28. The Future of Pharmacoepidemiology (Brian L. Strom and Stephen E. Kimmel).

Appendix A Sample Size Tables.

Appendix B Glossary.


""…a useful textbook for upper-level undergraduate, graduate, and postdoctoral fellows in pharmacy, medical, and public health programs."" (The Annals of Pharmacotherapy, June 2007)

""This is a major text with far-reaching impact…recommended for all courses in public health or pharmacology…"" (Electric Review, March/April 2007)

  • One-step resource to gain understanding of the subject of pharmacoepidemiology – at an affordable price.
  • A comprehensive text with practical emphasis to include: key methodology, data sources and applications
  • Perspective on subject given from academia, pharma industry and regulatory agencies
  • Designed for students with basic knowledge of epidemiology and public health
  • Key points summarise important take-home message of each chapter
  • Many case studies to illustrate pharmacoepidemiology in practice/ real clinical setting  
  • Short ref lists (5-10/chapter) and useful Biblio of further reading
  • Glossary of terms