Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.

The Editors Brian L. Strom is Chancellor, Rutgers Biomedical and Health Sciences and Executive Vice President for Health Affairs, Rutgers University, Newark, NJ, USA. Stephen E. Kimmel is Professor of Medicine and Director of the Division of Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. Sean Hennessy is Professor of Epidemiology and Director of the Center for Pharmacoepidemiology Research and Training, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.

Contributors x Preface xix Acknowledgments xxiii Part I Introduction 1 1 What is Pharmacoepidemiology? 3 Brian L. Strom 2 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies 27 Jeffrey S. Barrett 3 Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies 44 Brian L. Strom 4 Sample Size Considerations for Pharmacoepidemiologic Studies 60 Brian L. Strom 5 When Should One Perform Pharmacoepidemiologic Studies? 71 Brian L. Strom Part II The Role of Pharmacoepidemiology in Different Sectors 81 6 The Role of Pharmacoepidemiology in the Healthcare System and Academia 83 Joshua J. Gagne and Jerry Avorn 7 The Role of Pharmacoepidemiology in Industry 98 Nicolle M. Gatto, Rachel E. Sobel, Jamie Geier, Jingping Mo, Andrew Bate, and Robert F. Reynolds 8 The Role of Pharmacoepidemiology in Regulatory Agencies 126 Gerald J. Dal Pan, June Raine, and Shinobu Uzu 9 Pharmacoepidemiology and the Law 140 Aaron S. Kesselheim and Kerstin N. Vokinger Part III Sources of Data for Pharmacoepidemiology Research 165 Part IIIa Spontaneous Reporting 167 10 Postmarketing Spontaneous Pharmacovigilance Reporting Systems 169 Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin Part IIIb Electronic Data Systems 203 11 Overview of Electronic Databases in Pharmacoepidemiology 205 Brian L. Strom 12 Encounter Databases 211 Tobias Gerhard, Yola Moride, Anton Pottegård , and Nicole Pratt 13 Electronic Health Record Databases 241 Daniel B. Horton, Harshvinder Bhullar, Lucy Carty, Francesca Cunningham, Alexis Ogdie, Janet Sultana, and Gianluca Trifiro 14 Inpatient Databases 290 James A. Feinstein, Peter K. Lindenauer, Chris Feudtner, and Brian T. Fisher Part IIIc Studies Involving Ad Hoc Data Collection 305 15 Event Monitoring in the UK 307 Vicki Osborne and Saad A.W. Shakir 16 Primary Data Collection for Pharmacoepidemiology 342 Nancy A. Dreyer, Ana Filipa Macedo, and Priscilla Velentgas Part IIId Choosing a Data Source 355 17 Choosing among the Available Data Sources for Pharmacoepidemiology Research 357 Brian L. Strom Part IV Selected Applications of Pharmacoepidemiology 373 18 Studies of Drug Utilization 375 Björn Wettermark, Vera Vlahovic-Palcevski, David Lee, and Ulf Bergman 19 Evaluating and Improving Physician Prescribing 411 Christine Y. Lu, the late Sumit R. Majumdar, Helene Lipton, and Stephen B. Soumerai 20 Pharmacoepidemiologic Studies of Vaccine Safety 437 Robert T. Chen, Jason M. Glanz, and Tom T. Shimabukuro 21 Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices 496 Danica Marinac-Dabic, Sharon-Lise Normand, Art Sedrakyan, and Thomas P. Gross 22 Research on the Effects of Medications in Pregnancy and in Children 524 Daniel B. Horton, Sonia Hernandez-Diaz, Tamar Lasky, and Krista F. Huybrechts 23 Study of Biologics and Biosimilars 561 Jeffrey R. Curtis and James D. Lewis 24 Risk Management 581 Claudia Manzo, Emil Cochino, Lubna Merchant, and Giampiero Mazzaglia 25 Distributed Networks of Databases Analyzed Using Common Protocols and/or Common Data Models 617 Sengwee Toh, Nicole Pratt, Olaf Klungel, Joshua J. Gagne, and Robert W. Platt 26 Comparative Effectiveness Research 639 Soko Setoguchi and Ian Chi Kei Wong 27 Data Mining and Other Informatics Approaches to Pharmacoepidemiology 675 Andrew Bate, Gianluca Trifirò, Paul Avillach, and Stephen J.W. Evans 28 Pharmacoepidemiologic Research on Drugs of Abuse 701 Jana McAninch, Alex Secora, Cynthia Kornegay, and Judy Staffa Part V Selected Special Methodologic Issues in Pharmacoepidemiology 723 29 Assessing Causation from Case Reports 725 Judith K. Jones, Bernard Bégaud, and Elyse Kingery 30 Molecular Pharmacoepidemiology 746 Christine Y. Lu and Stephen E. Kimmel 31 Bioethical Issues in Pharmacoepidemiologic Research 772 Laura E. Bothwell, Annika Richterich, and Jeremy Greene 32 The Use of Randomized Controlled Trials in Pharmacoepidemiology 792 Robert F. Reynolds, Samuel M. Lesko, Nicolle M. Gatto, Tjeerd P. van Staa, and Allen A. Mitchell 33 The Use of Pharmacoepidemiology to Study Beneficial Drug Effects 813 Brian L. Strom and the late Kenneth L. Melmon 34 Pharmacoeconomics: The Economics of Pharmaceuticals 837 Kevin A. Schulman 35 Benefit-Risk Assessments of Medical Treatments 867 Bennett Levitan, Rachael DiSantostefano, and Scott Evans 36 The Use of Metaanalysis in Pharmacoepidemiology 897 Jesse A. Berlin, Brenda J. Crowe, H. Amy Xia, and Stephen J.W. Evans 37 Validity of Drug and Diagnosis Data in Pharmacoepidemiology 948 Mary Elizabeth Ritchey, Suzanne L. West, and George Maldonado 38 Studies of Medication Adherence 991 Julie Lauffenburger, Trisha Acri, and Robert Gross 39 Risk Evaluation and Communication 1010 Susan J. Blalock, Rebecca Dickinson, and Peter Knapp 40 Methods for Studying the Health Effects of Drug-Drug Interactions 1030 Sean Hennessy, Charles E. Leonard, Joshua J. Gagne, James H. Flory, Colleen M. Brensinger, and Warren B. Bilker 41 The Pharmacoepidemiology of Medication Errors 1046 Hanna M. Seidling and David W. Bates 42 Patient Engagement and Patient-Reported Outcomes 1061 Esi M. Morgan 43 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies 1078 Sebastian Schneeweiss and Samy Suissa Part VI Conclusion 1109 44 The Future of Pharmacoepidemiology 1111 Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy Appendix A Sample Size Tables 1123 Appendix B Glossary 1141 Index 1155