Schweitzer Fachinformationen
Wenn es um professionelles Wissen geht, ist Schweitzer Fachinformationen wegweisend. Kunden aus Recht und Beratung sowie Unternehmen, öffentliche Verwaltungen und Bibliotheken erhalten komplette Lösungen zum Beschaffen, Verwalten und Nutzen von digitalen und gedruckten Medien.
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 211Tobias 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 675Andrew 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 725Judith 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
Trisha Acri Philadelphia, PA USA
Paul Avillach Department of Biomedical Informatics Harvard Medical School Boston, MA USA
Jerry Avorn Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston, MA USA
Jeffrey S. Barrett Bill and Melinda Gates Medical Research Institute Cambridge, MA USA
Andrew Bate Pfizer Ltd Walton-on-the-Hill, Surrey UK
David W. Bates Division of General Internal Medicine and Primary Care Brigham and Women's Hospital and Harvard Medical School Boston, MA USA
Bernard Bégaud School of Medicine University of Bordeaux Bordeaux France
Ulf Bergman Division of Clinical Pharmacology Department of Laboratory Medicine Centre for Pharmacoepidemiology Karolinska Institute Karolinska University Hospital-Huddinge Stockholm Sweden
Jesse A. Berlin Johnson & Johnson Titusville, NJ USA
Harshvinder Bhullar Real-World Insights, IQVIA London UK
Warren B. Bilker University of Pennsylvania Perelman School of Medicine Philadelphia, PA USA
Susan J. Blalock Division of Pharmaceutical Outcomes and Policy Eshelman School of Pharmacy University of North Carolina at Chapel Hill Chapel Hill, NC USA
Laura E. Bothwell Health Sciences Department Worcester State University Worcester, MA USA
Colleen M. Brensinger University of Pennsylvania Perelman School of Medicine Philadelphia, PA USA
Lucy Carty Clinical Practice Research Datalink Medicines and Healthcare Products Regulatory Agency London UK
Robert T. Chen Brighton Collaboration Task Force for Global Health Decatur, GA USA
Emil Cochino European Medicines Agency Amsterdam The Netherlands
Brenda J. Crowe Eli Lilly and Company Indianapolis, IN USA
Francesca Cunningham Pharmacy Benefits Management, and Center for Medication Safety US Department of Veterans Affairs Hines, IL USA
Jeffrey R. Curtis Division of Clinical Immunology & Rheumatology University of Alabama at Birmingham Birmingham, AL USA
Gerald J. Dal Pan Office of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring, MD USA
Rebecca Dickinson School of Health and Community Studies Leeds Beckett University Leeds UK
Rachael L. DiSantostefano Janssen Research & Development Titusville, NJ USA
Nancy A. Dreyer IQVIA Real-World & Analytic Solutions Boston, MA University of North Carolina at Chapel Hill Chapel Hill, NC USA
Scott Evans Biostatistics Center The George Washington University Rockville, MD USA
Stephen J.W. Evans Department of Medical Statistics London School of Hygiene and Tropical Medicine London UK
James A. Feinstein Adult & Child Health Consortium for Health Outcomes Research and Delivery Science University of Colorado School of Medicine Aurora, CO USA
Chris Feudtner Center for Pediatric Clinical Effectiveness and PolicyLab The Children's Hospital of Philadelphia Philadelphia, PA USA
Brian T. Fisher Division of Infectious Diseases The Children's Hospital of Philadelphia Philadelphia, PA USA
James H. Flory Memorial Sloan Kettering Cancer Center New York, NY USA
Joshua J. Gagne Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston, MA, USA
Nicolle M. Gatto Department of Epidemiology, Worldwide Research and Development Pfizer, Inc. New York, NY USA
Jamie Geier Department of Epidemiology, Worldwide Research and Development Pfizer, Inc. New York, NY USA
Kate Gelperin Division of EpidemiologyOffice of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring, MD USA
Tobias Gerhard Rutgers Center for Pharmacoepidemiology and Treatment Science Rutgers Ernest Mario School of Pharmacy New Brunswick, NJ USA
Jason M. Glanz Institute for Health ResearchKaiser Permanente Colorado and Department of EpidemiologyColorado School of Public Health Denver, CO USA
Jeremy A. Greene Department of the History of Medicine The Johns Hopkins University School of Medicine Baltimore, MD USA
Robert Gross Departments of Medicine (ID) and Epidemiology/Biostatistics/Informatics Center for Clinical Epidemiology and Biostatistics University of Pennsylvania Perelman School of Medicine Philadelphia, PA USA
Thomas P. Gross Office of Surveillance and Biometrics Center for Devices and Radiological HealthUS Food and Drug Administration Silver Spring, MD USA
Sean Hennessy Center for Clinical Epidemiology and BiostatisticsUniversity of Pennsylvania Perelman School of Medicine Philadelphia, PA USA
Sonia Hernandez-Diaz Department of EpidemiologyHarvard T.H. Chan School of Public Health Boston, MA USA
Daniel B. Horton Department of PediatricsRutgers Robert Wood Johnson Medical School Rutgers Center for Pharmacoepidemiology and Treatment Science New Brunswick, NJ USA
Krista F. Huybrechts Division of Pharmacoepidemiology and PharmacoeconomicsDepartment of Medicine Brigham and Women's Hospital and Harvard Medical School Boston, MA USA
Judith K. Jones PharmaLex, Inc. Fairfax, VA University of Michigan School of Public Health Summer Program Ann Arbor, MI Georgetown University School of Medicine Washington, DC USA
Aaron S. Kesselheim Program On Regulation, Therapeutics, And Law (PORTAL) Division of Pharmacoepidemiology and PharmacoeconomicsDepartment of Medicine Brigham and Women's Hospital and Harvard Medical School Boston, MA USA
Stephen E. Kimmel Center for Clinical Epidemiology and Biostatistics University of Pennsylvania Perelman School of Medicine Philadelphia, PA USA
Elyse Kingery Degge Group, Ltd., a PharmaLex Company Fairfax, VA USA
Olaf Klungel Division of Pharmacoepidemiology & Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences (UIPS) Utrecht University Utrecht The Netherlands
Peter Knapp Department of Health Sciences and the Hull York Medical School University of York York UK
Cynthia Kornegay Division of EpidemiologyOffice of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring, MD USA
Tamar Lasky Office of Biostatistics and EpidemiologyCenter for Biologics Evaluation and Research US Food and Drug Administration Silver Spring, MD USA
Julie Lauffenburger Division of Pharmacoepidemiology and Pharmacoeconomics and Center for Healthcare Delivery Sciences Brigham and Women's Hospital and Harvard Medical School Boston, MA USA
David Lee Pharmaceuticals and Health Technologies GroupManagement Sciences for Health Arlington, VA USA
Charles E. Leonard University of Pennsylvania Perelman School of Medicine Philadelphia, PA USA
Samuel M. Lesko Northeast Regional Cancer Institute Scranton, PA USA
Bennett Levitan Department of Epidemiology Janssen Research & Development Titusville, NJ USA
James D. Lewis Department of Medicine Division of Gastroenterology Department of Biostatistics, Epidemiology, and InformaticsPerelman School of Medicine University of Pennsylvania Philadelphia, PA USA
Peter K. Lindenauer Center for Quality of Care Research Baystate Medical Center Springfield, MA USA
Marie Lindquist Uppsala Monitoring Centre WHO Collaborating Centre for International Drug Monitoring Uppsala Sweden
Helene Lipton School of Medicine and Pharmacy University of California at San Francisco San Francisco, CA USA
Christine Y. Lu Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Boston, MA USA
Ana Filipa Macedo Real-World Evidence Solutions Division QuintilesIMS Madrid Spain
Sumit R....
Dateiformat: ePUBKopierschutz: Adobe-DRM (Digital Rights Management)
Systemvoraussetzungen:
Das Dateiformat ePUB ist sehr gut für Romane und Sachbücher geeignet – also für „fließenden” Text ohne komplexes Layout. Bei E-Readern oder Smartphones passt sich der Zeilen- und Seitenumbruch automatisch den kleinen Displays an. Mit Adobe-DRM wird hier ein „harter” Kopierschutz verwendet. Wenn die notwendigen Voraussetzungen nicht vorliegen, können Sie das E-Book leider nicht öffnen. Daher müssen Sie bereits vor dem Download Ihre Lese-Hardware vorbereiten.Bitte beachten Sie: Wir empfehlen Ihnen unbedingt nach Installation der Lese-Software diese mit Ihrer persönlichen Adobe-ID zu autorisieren!
Weitere Informationen finden Sie in unserer E-Book Hilfe.
