Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic research, and provides descriptions of various automated data systems, along with the advantagesand disadvantages of each. Incorporating perspectives from academia, industryand regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology. INDICE: List of Contributors, ixPreface, xviAcknowledgements, xxPART I Introduction, 11 What is Pharmacoepidemiology?, 3Brian L. Strom2 Basic Principlesof Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies, 23JeffreyS. Barrett and Athena F. Zuppa3 Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies, 38Brian L. Strom4 Sample Size Considerations for Pharmacoepidemiologic Studies, 52Brian L. Strom5 When Should One Perform Pharmacoepidemiologic Studies?, 62Brian L. StromPART II The Role of Pharmacoepidemiology in Different Sectors, 716 The Role of Pharmacoepidemiology inthe Health-Care System and Academia, 73Jerry Avorn7 The Role of Pharmacoepidemiology in Industry, 84Jingping Mo, Nicolle M. Gatto, Rachel E. Sobel, and Robert F. Reynolds8 The Role of Pharmacoepidemiology in Regulatory Agencies, 107Gerald J. Dal Pan and Peter Arlett9 Pharmacoepidemiology and the Law, 117Aaron S. KesselheimPART III Sources of Data for Pharmacoepidemiologic Studies, 135Section A: Spontaneous Reporting10 Postmarketing Spontaneous Pharmacovigilance Reporting Systems, 137Gerald J. Dal Pan, Marie Lindquist, and Kate GelperinSection B: Automated Data Systems11 Overview of Automated Databases in Pharmacoepidemiology, 158Brian L. Strom12 Health Maintenance Organizations/Health Plans, 163Susan E. Andrade, Marsha A. Raebel, Denise Boudreau, Robert L. Davis, Katherine Haffenreffer, Pamala A. Pawloski, Sengwee Toh, and Richard Platt13 Commercial Insurance Databases, 189John Seeger and Gregory W. Daniel14 US Government Claims Databases, 209Sean Hennessy, Cristin Palumbo Freeman, and Francesca Cunningham15 Medical Record Databases, 224Alexis Ogdie, Sinéad M. Langan, John Parkinson, Hassy Dattani, Karel Kostev, and Joel M. Gelfand16 In-hospital Databases, 244Brian T. Fisher, Peter K. Lindenauer, and Chris Feudtner17 Canadian Provincial Databases, 259Yola Moride and Colleen J. Metge18 Pharmacy-based Medical Record Linkage Systems, 270Ron M.C. Herings and Lars PedersenSection C: Ad Hoc Studies—Ongoing Systems for Pharmacoepidemiologic Studies19 Case-Control Surveillance, 287Lynn Rosenberg, Patricia F. Coogan, and Julie R. Palmer20 Prescription-Event Monitoring, 301Deborah Layton and Saad A.W. Shakir21 Registries, 331Nancy A. Dreyer and Priscilla VelentgasSection D: Ad Hoc Studies—De Novo Studies22 Field Studies, 347David W. KaufmanSection E: Choosing Among the Available Alternatives23 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives, 364Brian L. StromPART IV Selected Special Applications of Pharmacoepidemiology, 37724 Studies ofDrug Utilization, 379David Lee and Ulf Bergman25 Evaluating and Improving Physician Prescribing, 402Sumit R. Majumdar, Helene Levens Lipton, and Stephen B. Soumerai26 Pharmacoepidemiologic Studies of Vaccine Safety, 423Robert T. Chen, Jason M. Glanz, and Claudia Vellozzi27 Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices, 469Danica Marinac-Dabic, Sharon-Lise Normand, Art Sedrakyan, and Thomas Gross28 Studies of Drug-Induced Birth Defects, 487Allen A. Mitchell29 Risk Management, 505Gerald J.Dal Pan, Stella Blackburn, and Claudia Karwoski30 FDA’s Sentinel Initiative: Active Surveillance to Identify Safety Signals, 534Judith A. Racoosin, Melissa A. Robb, Rachel E. Sherman, and Janet Woodcock31 Pharmacoepidemiology andPharmaceutical Reimbursement Policy, 555Mitchell Levine and Jacques LeLorier32 Comparative Effectiveness Research, 561Brian L. Strom, Rita Schinnar, and Sean HennessyPART V Selected Special Methodologic Issues in Pharmacoepidemiology, 58133 Assessing Causality of Case Reports of Suspected Adverse Events, 583Judith K. Jones34 Molecular Pharmacoepidemiology, 601Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck35 Bioethical Issues in Pharmacoepidemiologic Research, 623Antoine C. El Khoury, Jason Karlawish, Elizabeth Andrews, and Arthur Caplan36 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies, 640Samuel M. Lesko and Allen A. Mitchell37 The Use of Pharmacoepidemiology to Study Beneficial Drug Effects, 655Brian L. Strom and KennethL. Melmon38 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals, 678Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed39 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research, 709Holger Schünemann, Bradley C. Johnston, Roman Jaeschke, and Gordon H. Guyatt40 The Use ofMeta-analysis in Pharmacoepidemiology, 723Jesse A. Berlin, M. Soledad Cepeda,and Carin J. Kim41 Validity of Pharmacoepidemiologic Drug and Diagnosis Data, 757Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole42 Studies of Medication Adherence, 795Trisha Acri and Robert Gross43 Risk Evaluation and Communication, 810Susan J. Blalock and Betsy L. Sleath44 Studying Effects of Antibiotics, 827Darren R. Linkin and Ebbing Lautenbach45 The Pharmacoepidemiology of Medication Errors, 840Hanna M. Seidling and David W. Bates46 Sequential Statistical Methods for Prospective Postmarketing Safety Surveillance, 852Martin Kulldorff47 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies, 868Sebastian Schneeweiss and Samy SuissaPART VI Conclusion, 89348 The Future of Pharmacoepidemiology, 895Brian L. Strom, Stephen E. Kimmel, and Sean HennessyAppendix A: Sample Size Tables, 904Appendix B: Glossary, 921Index, 931
- ISBN: 978-1-119-95994-6
- Editorial: John Wiley & Sons
- Encuadernacion: Rústica
- Páginas: 1008
- Fecha Publicación: 03/04/2012
- Nº Volúmenes: 1
- Idioma: Inglés