Textbook of Pharmacoepidemiology, Second Edition, provides an introduction to pharmacoepidemiology and the data sources, methods and applications used in clinical research, the pharmaceutical industry
and regulatory agencies.
Drawing upon the fifth edition of the authoritative reference, Pharmacoepidemiology, this new edition covers the key learning requirements of the discipline. The textbook provides an introduction to
pharmacoepidemiology, pharmacoepidemiological data sources, special issues in methodology, special applications and future developments in the field. Updated learning features such as case studies, key points and Suggested Further Reading are included throughout the text.
Textbook of Pharmacoepidemiology is a practical educational resource for upper-level undergraduates, graduate students, post-doctoral fellows in schools of public health, pharmacy and medicine, and for everyone learning and working in pharmacoepidemiology.
Daftar Isi
Preface, xiii
Acknowledgements, xvii
Part I Introduction to Pharmacoepidemiology 1
1 What is Pharmacoepidemiology? 3
Brian L. Strom
2 Study Designs Available for Pharmacoepidemiologic Studies17
Brian L. Strom
3 Sample Size Considerations for Pharmacoepidemiologic Studies30
Brian L. Strom
4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies 40
Jeffrey S. Barrett and Athena F. Zuppa
5 When Should One Perform Pharmacoepidemiologic Studies?54
Brian L. Strom
6 Views from Academia, Industry, Regulatory Agencies, and the Legal System 63
Jerry Avorn, Jingping Mo, Robert F. Reynolds, Gerald J. Dal Pan, Peter Arlett, and Aaron S. Kesselheim
Part II Sources of Pharmacoepidemiology Data 99
7 Postmarketing Spontaneous Pharmacovigilance Reporting Systems101
Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin
8 Overview of Automated Databases in Pharmacoepidemiology118
Brian L. Strom
9 Examples of Existing Automated Databases 123
Sengwee Toh, Susan E. Andrade, Marsha A. Raebel, Denise M.Boudreau, Robert L. Davis, Katherine Haffenreffer, Pamala A.Pawloski, Richard Platt, Sean Hennessy, Cristin Palumbo Freeman, Francesca Cunningham, Yola Moride, Alexis Ogdie, Sinead M. Langan, John Parkinson, Hassy Dattani, Karel Kostev, Joel M. Gelfand, Ron M.C. Herings, and Lars Pedersen
10 Field Studies 178
David W. Kaufman
11 How Should One Perform Pharmacoepidemiologic Studies?Choosing Among the Available Alternatives 190
Brian L. Strom
Part III Special Issues in Pharmacoepidemiology Methodology203
12 Validity of Pharmacoepidemiologic Drug and Diagnosis Data205
Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole
13 Assessing Causality of Case Reports of Suspected Adverse Events 228
Judith K. Jones
14 Molecular Pharmacoepidemiology 239
Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R.Rebbeck
15 Bioethical Issues in Pharmacoepidemiologic Research 256
Antoine C. El Khoury
16 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies 269
Samuel M. Lesko and Allen A. Mitchell
17 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals280
Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D.Reed
18 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research 291
Holger J. Sch EURunemann, Bradley C. Johnston, Roman Jaeschke, and Gordon H. Guyatt
19 The Use of Meta-analysis in Pharmacoepidemiology 300
Jesse A. Berlin and M. Soledad Cepeda
20 Studies of Medication Adherence 314
Trisha Acri and Robert Gross
21 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies 324
Sebastian Schneeweiss and Samy Suissa
Part IV Special Applications 337
22 Special Applications of Pharmacoepidemiology 339
David Lee, Sumit R. Majumdar, Helene L. Lipton, Stephen B.Soumerai, Claudia Vellozzi, Robert T. Chen, Jason Glanz, Danica Marinac-Dabic, Sharon-Lise T. Normand, Art Sedrakyan, Allen A.Mitchell, Gerald J. Dal Pan, Stella Blackburn, Claudia Manzo, Hanna M. Seidling, David W. Bates, Melissa A. Robb, Rachel E. Sherman, Brian L. Strom, Rita Schinnar, and Sean Hennessy
23 The Future of Pharmacoepidemiology 407
Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy
Appendix A–Sample Size Tables 417
Appendix B–Glossary 435
Index 445
Tentang Penulis
Edited by
Brian L. Strom, MD, MPH
Executive Vice Dean for Institutional Affairs, George S. Pepper Professor of Public Health
and Preventive Medicine, Professor of Biostatistics and Epidemiology, of Medicine, and
of Pharmacology, Center for Clinical Epidemiology and Biostatistics, Center for
Pharmacoepidemiology Research and Training, Perelman School of Medicine at the
University of Pennsylvania, Philadelphia, PA, USA
Stephen E. Kimmel, MD, MSCE
Professor of Medicine and of Epidemiology, Center for Clinical Epidemiology and
Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School
of Medicine at the University of Pennsylvania, Philadelphia, PA, USA
Sean Hennessy, Pharm D, Ph D
Associate Professor of Epidemiology and of Pharmacology, Center for Clinical Epidemiology
and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School
of Medicine at the University of Pennsylvania, Philadelphia, PA, USA
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