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|a Front Matter -- Introduction. What is Pharmacoepidemiology? / Brian L Strom -- Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies / Jeffrey S Barrett, Athena F Zuppa -- Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies / Brian L Strom -- Sample Size Considerations for Pharmacoepidemiologic Studies / Brian L Strom -- When Should One Perform Pharmacoepidemiologic Studies? / Brian L Strom -- The Role of Pharmacoepidemiology in Different Sectors. The Role of Pharmacoepidemiology in the Health-Care System and Academia / Jerry Avorn -- The Role of Pharmacoepidemiology in Industry / Jingping Mo, Nicolle M Gatto, Rachel E Sobel, Robert F Reynolds -- The Role of Pharmacoepidemiology in Regulatory Agencies / Gerald J Dal Pan, Peter Arlett -- Pharmacoepidemiology and the Law / Aaron S Kesselheim -- Sources of Data for Pharmacoepidemiologic Studies. Postmarketing Spontaneous Pharmacovigilance Reporting Systems / Gerald J Dal Pan, Marie Lindquist, Kate Gelperin -- Overview of Automated Databases in Pharmacoepidemiology / Brian L Strom -- Health Maintenance Organizations/Health Plans / Susan E Andrade, Marsha A Raebel, Denise Boudreau, Robert L Davis, Katherine Haffenreffer, Pamala A Pawloski, Sengwee Toh, Richard Platt -- Commercial Insurance Databases / John Seeger, Gregory W Daniel -- US Government Claims Databases / Sean Hennessy, Cristin Palumbo Freeman, Francesca Cunningham -- Medical Record Databases / Alexis Ogdie, Siňad M Langan, John Parkinson, Hassy Dattani, Karel Kostev, Joel M Gelfand -- In-Hospital Databases / Brian T Fisher, Peter K Lindenauer, Chris Feudtner -- Canadian Provincial Databases / Yola Moride, Colleen J Metge -- Pharmacy-Based Medical Record Linkage Systems / Ron M C Herings, Lars Pedersen -- Case₆Control Surveillance / Lynn Rosenberg, Patricia F Coogan, Julie R Palmer -- Prescription₆Event Monitoring / Deborah Layton, Saad A W Shakir -- Registries / Nancy A Dreyer, Priscilla Velentgas -- Field Studies / David W Kaufman -- How Should One Perform Pharmacoepidemiologic Studies? Choosing among the Available Alternatives / Brian L Strom -- Selected Special Applications of Pharmacoepidemiology. Studies of Drug Utilization / David Lee, Ulf Bergman -- Evaluating and Improving Physician Prescribing / Sumit R Majumdar, Helene Levens Lipton, Stephen B Soumerai -- Pharmacoepidemiologic Studies of Vaccine Safety / Robert T Chen, Jason M Glanz, Claudia Vellozzi -- Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices / Danica Marinac-Dabic, Sharon-Lise Normand, Art Sedrakyan, Thomas Gross -- Studies of Drug-Induced Birth Defects / Allen A Mitchell -- Risk Management / Gerald J Dal Pan, Stella Blackburn, Claudia Karwoski -- FDA's Sentinel Initiative: Active Surveillance to Identify Safety Signals / Judith A Racoosin, Melissa A Robb, Rachel E Sherman, Janet Woodcock -- Pharmacoepidemiology and Pharmaceutical Reimbursement Policy / Mitchell Levine, Jacques Lelorier -- Comparative Effectiveness Research / Brian L Strom, Rita Schinnar, Sean Hennessy -- Selected Special Methodologic Issues in Pharmacoepidemiology. Assessing Causality of Case Reports of Suspected Adverse Events / Judith K Jones -- Molecular Pharmacoepidemiology / Stephen E Kimmel, Hubert G Leufkens, Timothy R Rebbeck -- Bioethical Issues in Pharmacoepidemiologic Research / Antoine C El Khoury, Jason Karlawish, Elizabeth Andrews, Arthur Caplan -- The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies / Samuel M Lesko, Allen A Mitchell -- The Use of Pharmacoepidemiology to Study Beneficial Drug Effects / Brian L Strom, Kenneth L Melmon -- Pharmacoeconomics: Economic Evaluation of Pharmaceuticals / Kevin A Schulman, Henry A Glick, Daniel Polsky, Shelby D Reed -- Using Quality-of-Life Measurements in Pharmacoepidemiologic Research / Holger Schunemann, Bradley C Johnston, Roman Jaeschke, Gordon H Guyatt -- The Use of Meta-analysis in Pharmacoepidemiology / Jesse A Berlin, Soledad Cepeda, Carin J Kim -- Validity of Pharmacoepidemiologic Drug and Diagnosis Data / Suzanne L West, Mary Elizabeth Ritchey, Charles Poole -- Studies of Medication Adherence / Trisha Acri, Robert Gross -- Risk Evaluation and Communication / Susan J Blalock, Betsy L Sleath -- Studying Effects of Antibiotics / Darren R Linkin, Ebbing Lautenbach -- The Pharmacoepidemiology of Medication Errors / Hanna M Seidling, David W Bates -- Sequential Statistical Methods for Prospective Postmarketing Safety Surveillance / Martin Kulldorff -- Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies / Sebastian Schneeweiss, Samy Suissa -- Conclusion. The Future of Pharmacoepidemiology / Brian L Strom, Stephen E Kimmel, Sean Hennessy -- Appendix A: Sample Size Tables -- Appendix B: Glossary -- Index.
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