Table of Contents

List of Contributors. Preface. Acknowledgments. Acknowledgments from Pharmacoepidemiology, Fourth Edition. SECTION I INTRODUCTION TO PHARMACOEPIDEMIOLOGY. 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). SECTION II SOURCES OF PHARMACOEPIDEMIOLOGY DATA. 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). SECTION III SPECIAL ISSUES IN PHARMACOEPIDEMIOLOGY METHODOLOGY. 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 Schunemann, 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). SECTION IV SPECIAL APPLICATIONS OF PHARMACOEPIDEMIOLOGY. 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. Index.

About the Author

Brian L. Strom, University of Pennsylvania School of Medicine, USA. Stephen E. Kimmel, Associate Professor of Medicine and Epidemiology, University of Pennsylvania School of Medicine, USA.

Reviews

"...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) "...the quality of this book bears out (the editors) well-earned reputations." (The Irish Pharmacy Journal, July 2007)