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Edited byBrian L. Strom, MD, MPHExecutive Vice Dean for Institutional Affairs, George S. Pepper Professor of Public Healthand Preventive Medicine, Professor of Biostatistics and Epidemiology, of Medicine, andof Pharmacology, Center for Clinical Epidemiology and Biostatistics, Center forPharmacoepidemiology Research and Training, Perelman School of Medicine at theUniversity of Pennsylvania, Philadelphia, PA, USA
Stephen E. Kimmel, MD, MSCEProfessor of Medicine and of Epidemiology, Center for Clinical Epidemiology andBiostatistics, Center for Pharmacoepidemiology Research and Training, Perelman Schoolof Medicine at the University of Pennsylvania, Philadelphia, PA, USA
Sean Hennessy, PharmD, PhDAssociate Professor of Epidemiology and of Pharmacology, Center for Clinical Epidemiologyand Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman Schoolof Medicine at the University of Pennsylvania, Philadelphia, PA, USA
List of Contributors
Preface to Second Edition
Acknowledgements
I. INTRODUCTION TO PHARMACOEPIDEMIOLOGY
1. What is Pharmacoepidemiology?Brian L. Strom
2. Study Designs Available for Pharmacoepidemiology StudiesBrian L. Strom
3. Sample Size Considerations for Pharmacoepidemiology StudiesBrian L. Strom
4. Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiology StudiesJeffrey Barrett and Athena F. Zuppa
5. When Should One Perform Pharmacoepidemiology Studies?Brian L. Strom
6. Views from Academia, Industry, Regulatory Agencies, and the Legal System
The View from AcademiaJerry Avorn
The View from IndustryJingping Mo and Robert F. Reynolds
The View from Regulatory AgenciesGerald J. Dal Pan and Peter Arlett
The View from the Legal SystemAaron S. Kesselheim
II. SOURCES OF PHARMACOEPIDEMIOLOGY DATA
7. Postmarketing Spontaneous Pharmacovigilance Reporting SystemsGerald J. Dal Pan, Marie Lindquist, and Kate Gelperin
8. Overview of Automated Databases in Pharmacoepidemiology Brian L. Strom
9. Examples of Existing Databases:
Health Maintenance Organizations / Health PlansSengwee Toh, Susan E. Andrade, Marsha A. Raebel, Denise Boudreau, Robert L. Davis, Katherine Haffenreffer, Pamala A. Pawloski, Richard Platt is
US Government Claims DatabasesSean Hennessy, Cristin Palumbo Freeman, Francesca Cunningham
Medical Record DatabasesAlexis Ogdie, Sinéad M Langan, John Parkinson, Hassy Dattani, Karel Kostev and Joel M Gelfand
Canadian provincial databasesYola Moride
Pharmacy-based Medical Record Linkage SystemsRon MC Herings and Lars Pedersen
10. Field Studies David F Kaufman
11. How Should One Perform Pharmacoepidemiology Studies? Choosing Among the Available AlternativesBrian L. Strom
III. SPECIAL ISSUES IN PHARMACOEPIDEMIOLOGY METHODOLOGY
12. Validity of Pharmacoepidemiologic Drug and Diagnosis Data Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole
13. Inferring Causation from Case ReportsJudith K. Jones
14. Molecular PharmacoepidemiologyStephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck
15. Bioethical Issues in Pharmacoepidemiologic ResearchAntoine C El Khoury
16. The Use of Randomized Controlled Trials for Pharmacoepidemiologic StudiesSamuel M. Lesko and Allen A. Mitchell
17. Pharmacoeconomics: Economic Evaluation of PharmaceuticalsKevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed
18. Using Quality-of-Life Measurements in Pharmacoepidemiologic ResearchHolger J. Schünemann, Bradley C. Johnston, Roman Jaeschke, Gordon H. Guyatt
19. The Use of Meta-analysis in PharmacoepidemiologyJesse A. Berlin and M. Soledad Cepeda
20. Studies of Medication Adherence Trisha Acri and Robert Gross
21. Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic ResearchSebastian Schneeweiss and Samy Suissa
IV. SPECIAL APPLICATIONS
22. Special Applications of Pharmacoepidemiology
Studies of Drug UtilizationDavid Lee
Evaluating and Improving Physician Prescribing Sumit R. Majumdar, Helene L. Lipton, and Stephen B. Soumerai
Special Methodological Issues in Pharmacoepidemiology Studies of Vaccine SafetyClaudia Vellozzi, Robert T. Chen, and Jason Glanz
Pharmacoepidemiologic Studies of DevicesDanica Marinac-Dabic, Sharon-Lise T. Normand, and Art Sedrakyan
Studies of Drug-Induced Birth DefectsAllen A. Mitchell
Risk ManagementGerald J. Dal Pan, Stella Blackburn, and Claudia Karwoski
The Use of Pharmacoepidemiology to Study Medication ErrorsDavid W. Bates
FDA SentinelMelissa A. Robb and Rachel E. Sherman
Comparative Effectiveness ResearchBrian L. Strom, Rita Schinnar, and Sean Hennessy
23. The Future of PharmacoepidemiologyBrian L. Strom, Stephen E. Kimmel, and Sean Hennessy
Appendix A – Sample size tables
Appendix B – Glossary
Index
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