Pharmacoepidemiology
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品牌: Brian L. StromStephen E KimmelSean Hennessy
基本信息出版社:Wiley-Blackwell; 5 (2012年3月20日)精装:976页正文语种:英语ISBN:0470654759条形码:9780470654750商品尺寸:19.6 x 4.2 x 24.5 cm商品重量:2 KgASIN:0470654759商品描述内容简介Now in its fifth edition,Pharmacoepidemiologydefines 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 advantages and disadvantages of each. Incorporating perspectives from academia, industry and regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology.目录List of Contributors, ixPreface, xviAcknowledgements, xxPART I Introduction, 11 What is Pharmacoepidemiology?, 3
Brian L. Strom2 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies, 23
Jeffrey S. Barrett and Athena F. Zuppa3 Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies, 38
Brian L. Strom4 Sample Size Considerations for Pharmacoepidemiologic Studies, 52
Brian L. Strom5 When Should One Perform Pharmacoepidemiologic Studies?, 62
Brian L. StromPART II The Role of Pharmacoepidemiology in Different Sectors, 716 The Role of Pharmacoepidemiology in the Health-Care System and Academia, 73
Jerry Avorn7 The Role of Pharmacoepidemiology in Industry, 84
Jingping Mo, Nicolle M. Gatto, Rachel E. Sobel, and Robert F. Reynolds8 The Role of Pharmacoepidemiology in Regulatory Agencies, 107
Gerald J. Dal Pan and Peter Arlett9 Pharmacoepidemiology and the Law, 117
Aaron S. KesselheimPART III Sources of Data for Pharmacoepidemiologic Studies, 135Section A: Spontaneous Reporting10 Postmarketing Spontaneous Pharmacovigilance Reporting Systems, 137
Gerald J. Dal Pan, Marie Lindquist, and Kate GelperinSection B: Automated Data Systems11 Overview of Automated Databases in Pharmacoepidemiology, 158
Brian L. Strom12 Health Maintenance Organizations/Health Plans, 163
Susan E. Andrade, Marsha A. Raebel, Denise Boudreau, Robert L. Davis, Katherine Haffenreffer, Pamala A. Pawloski, Sengwee Toh, and Richard Platt13 Commercial Insurance Databases, 189
John Seeger and Gregory W. Daniel14 US Government Claims Databases, 209
Sean Hennessy, Cristin Palumbo Freeman, and Francesca Cunningham15 Medical Record Databases, 224
Alexis Ogdie, Sinéad M. Langan, John Parkinson, Hassy Dattani, Karel Kostev, and Joel M. Gelfand16 In-hospital Databases, 244
Brian T. Fisher, Peter K. Lindenauer, and Chris Feudtner17 Canadian Provincial Databases, 259
Yola Moride and Colleen J. Metge18 Pharmacy-based Medical Record Linkage Systems, 270
Ron M.C. Herings and Lars PedersenSection C: Ad Hoc Studies—Ongoing Systems for Pharmacoepidemiologic Studies19 Case–Control Surveillance, 287
Lynn Rosenberg, Patricia F. Coogan, and Julie R. Palmer20 Prescription–Event Monitoring, 301
Deborah Layton and Saad A.W. Shakir21 Registries, 331
Nancy A. Dreyer and Priscilla VelentgasSection D: Ad Hoc Studies—De Novo Studies22 Field Studies, 347
David W. KaufmanSection E: Choosing Among the Available Alternatives23 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives, 364
Brian L. StromPART IV Selected Special Applications of Pharmacoepidemiology, 37724 Studies of Drug Utilization, 379
David Lee and Ulf Bergman25 Evaluating and Improving Physician Prescribing, 402
Sumit R. Majumdar, Helene Levens Lipton, and Stephen B. Soumerai26 Pharmacoepidemiologic Studies of Vaccine Safety, 423
Robert T. Chen, Jason M. Glanz, and Claudia Vellozzi27 Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices, 469
Danica Marinac-Dabic, Sharon-Lise Normand, Art Sedrakyan, and Thomas Gross28 Studies of Drug-Induced Birth Defects, 487
Allen A. Mitchell29 Risk Management, 505
Gerald J. Dal Pan, Stella Blackburn, and Claudia Karwoski30 FDA’s Sentinel Initiative: Active Surveillance to Identify Safety Signals, 534
Judith A. Racoosin, Melissa A. Robb, Rachel E. Sherman, and Janet Woodcock31 Pharmacoepidemiology and Pharmaceutical Reimbursement Policy, 555
Mitchell Levine and Jacques LeLorier32 Comparative Effectiveness Research, 561
Brian L. Strom, Rita Schinnar, and Sean HennessyPART V Selected Special Methodologic Issues in Pharmacoepidemiology, 58133 Assessing Causality of Case Reports of Suspected Adverse Events, 583
Judith K. Jones34 Molecular Pharmacoepidemiology, 601
Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck35 Bioethical Issues in Pharmacoepidemiologic Research, 623
Antoine C. El Khoury, Jason Karlawish, Elizabeth Andrews, and Arthur Caplan36 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies, 640
Samuel M. Lesko and Allen A. Mitchell37 The Use of Pharmacoepidemiology to Study Beneficial Drug Effects, 655
Brian L. Strom and Kenneth L. Melmon38 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals, 678
Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed39 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research, 709
Holger Schünemann, Bradley C. Johnston, Roman Jaeschke, and Gordon H. Guyatt40 The Use of Meta-analysis in Pharmacoepidemiology, 723
Jesse A. Berlin, M. Soledad Cepeda, and Carin J. Kim41 Validity of Pharmacoepidemiologic Drug and Diagnosis Data, 757
Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole42 Studies of Medication Adherence, 795
Trisha Acri and Robert Gross43 Risk Evaluation and Communication, 810
Susan J. Blalock and Betsy L. Sleath44 Studying Effects of Antibiotics, 827
Darren R. Linkin and Ebbing Lautenbach45 The Pharmacoepidemiology of Medication Errors, 840
Hanna M. Seidling and David W. Bates46 Sequential Statistical Methods for Prospective Postmarketing Safety Surveillance, 852
Martin Kulldorff47 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies, 868
Sebastian Schneeweiss and Samy SuissaPART VI Conclusion, 89348 The Future of Pharmacoepidemiology, 895
Brian L. Strom, Stephen E. Kimmel, and Sean HennessyAppendix A: Sample Size Tables, 904Appendix B: Glossary, 921Index, 931
