Pharmacoepidemiology originally arose from the union of the fields of clinical pharmacology and epidemiology. Pharmacoepidemiology studies the use of and the effects of medical products in large numbers of people and applies the methods of epidemiology to the content area of clinical pharmacology. This field represents the science underlying studies of the effects of medical products (such as drugs, biologicals, and devices) in real world use.
Strom’s Textbook of Pharmacoepidemiology meets the increasing need for people to be trained in the field. Designed to meet the need of students, this textbook offers an approach that focuses on the core of the discipline, providing a focused educational resource for students. The book is designed for students at all levels: upper-level undergraduates, graduate students, post-doctoral fellows, and others who are learning the field. Case examples feature in most chapters, and all chapters include key points and a list of further reading.
Fully revised and updated throughout, Textbook of Pharmacoepidemiology, 3rd edition is a useful introduction and resource for students of pharmacoepidemiology, both those enrolled in formal classes and those learning in ‘the real world, ‘ who will respond to the challenges that they encounter.
Jadual kandungan
Contributors
Preface
Acknowledgements
Part I Introduction to Pharmacoepidemiology
1 What is Pharmacoepidemiology?
Brian L. Strom
2 Study Designs Available for Pharmacoepidemiologic Studies
Brian L. Strom
3 Sample Size Considerations for Pharmacoepidemiologic Studies
Brian L. Strom
4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies
Jeffrey S. Barrett
5 When Should One Perform Pharmacoepidemiologic Studies?
Brian L. Strom
6 Views from Academia, Industry, Regulatory Agencies, and the Legal System
Joshua J Gagne, Jerry Avorn, Nicolle M Gatto, Jingping Mo, Gerald J. Dal Pan, June Raine, Shinobu Uzu, Aaron S. Kesselheim, Kerstin N. Vokinger
Part II Sources of Pharmacoepidemiology Data
7 Postmarketing Spontaneous Pharmacovigilance Reporting Systems
Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin
8 Overview of Electronic Databases in Pharmacoepidemiology
Brian L. Strom
9 Encounter Databases
Tobi Gerhard, Yola Moride, Anton Pottegard, Nicole Pratt
10 Electronic Health Record Databases
Daniel Horton, Harshvinder Bhullar, Francesca Cunningham, Janet Sultana B. Pharm (Hons.), and Gialuca Trifiro
11 Primary Data Collection for Pharmacoepidemiology
Priscilla Velentgas
12 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives
Brian L. Strom
Part III Special Issues in Pharmacoepidemiology Methodology
13 Validity of Drug and Diagnosis Data in Pharmacoepidemiology
Mary Elizabeth Ritchey, Suzanne L West, and George Maldonado
14 Assessing Causality from Case Reports
Bernard Begaud, and the late Judith K. Jones
15 Molecular Pharmacoepidemiology
Christine Y Lu and Stephen E. Kimmel
16 Bioethical Issues in Pharmacoepidemiologic Research
Laura E Bothwell, Annika Richterich, and Jeremy Greene
17 The Use of Randomized Controlled Trials in Pharmacoepidemiology
Robert Reynolds, Samuel M. Lesko, Allen A. Mitchell
18 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals
Kevin A. Schulman
19 Patient Engagement and Patient Reported Outcomes
Esi Morgan
20 The Use of Meta-analysis in Pharmacoepidemiology
Jesse A. Berlin, Vrenda J Crowe, H Amy Xia, and Stephen JW Evans
21 Studies of Medication Adherence
Julie Lauffenburger, Trisha Acri, and Robert Gross
22 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies
Sebastian Schneeweiss and Samy Suissa
Part IV Special Applications and The Future of Pharmacoepidemiology
23 Special Applications of Pharmacoepidemiology, 339
David Lee, Björn Wettermark, Christine Y. Lu, Stephen B. Soumerai, Robert T. Chen, Sharon-Lise T. Normand, Art Sedrakyan, Danica Marinac-Dabic, Daniel B. Horton, Sonia Hernandez-Diaz, Tamar Lasky, Krista F. Huybrechts, Claudia Manzo, Emil Cochino, Hanna M. Seidling, David W. Bates, Bennett Levitan, Rachel Di Santostefano, Scott Evans
Studies of Drug Utilization
Evaluating and Improving Prescribing
Special Methodological Issues in Pharmacoepidemiologic Studies of Vaccine Safety
Epidemiologic Studies of Implantable Devices
Research on the Effects of Medications in Pregnancy and in Children
Risk Management
The Pharmacoepidemiology of Medication Errors
Benefit-Risk Assessments of Medical Treatments.
24 The Future of Pharmacoepidemiology
Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy
Appendix A — Sample Size Tables
Appendix B — Glossary
Index
Mengenai Pengarang
About the Editors
Brian L. Strom is Chancellor, Rutgers Biomedical and Health Sciences, University Professor, and Executive Vice President for Health Affairs, Rutgers University, Newark, NJ, USA.
Stephen E. Kimmel is Dean’s Professor and Chair of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, 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.
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