TEXTBOOK OF PHARMACOEPIDEMIOLOGY

• 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

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

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 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).

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.