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Textbook of Pharmacoepidemiology, 2nd Edition



Textbook of Pharmacoepidemiology, 2nd Edition

Brian L. Strom (Editor), Stephen E. Kimmel (Editor), Sean Hennessy (Editor)

ISBN: 978-1-118-34486-6 September 2013 Wiley-Blackwell 480 Pages

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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.

Preface, xiii

Acknowledgements, xvii

Part I Introduction to Pharmacoepidemiology 1

1 What is Pharmacoepidemiology? 3
Brian L. Strom

2 Study Designs Available for Pharmacoepidemiologic Studies 17
Brian L. Strom

3 Sample Size Considerations for Pharmacoepidemiologic Studies 30
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 Systems 101
Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin

8 Overview of Automated Databases in Pharmacoepidemiology 118
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 PharmacoepidemiologyMethodology 203

12 Validity of Pharmacoepidemiologic Drug and Diagnosis Data 205
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 Pharmaceuticals 280
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€unemann, 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