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.
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.
Inhaltsangabe
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
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
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