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<p><b>Preface, xiii</b></p> <p><b>Acknowledgements, xvii</b></p> <p><b>Part I Introduction to Pharmacoepidemiology 1</b></p> <p>1 What is Pharmacoepidemiology? 3<br /> <i>Brian L. Strom</i></p> <p>2 Study Designs Available for Pharmacoepidemiologic Studies 17<br /> <i>Brian L. Strom</i></p> <p>3 Sample Size Considerations for Pharmacoepidemiologic Studies 30<br /> <i>Brian L. Strom</i></p> <p>4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies 40<br /> <i>Jeffrey S. Barrett and Athena F. Zuppa</i></p> <p>5 When Should One Perform Pharmacoepidemiologic Studies? 54<br /> <i>Brian L. Strom</i></p> <p>6 Views from Academia, Industry, Regulatory Agencies, and the Legal System 63<br /> <i>Jerry Avorn, Jingping Mo, Robert F. Reynolds, Gerald J. Dal Pan, Peter Arlett, and Aaron S. Kesselheim</i></p> <p><b>Part II Sources of Pharmacoepidemiology Data 99</b></p> <p>7 Postmarketing Spontaneous Pharmacovigilance Reporting Systems 101<br /> <i>Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin</i></p> <p>8 Overview of Automated Databases in Pharmacoepidemiology 118<br /> <i>Brian L. Strom</i></p> <p>9 Examples of Existing Automated Databases 123<br /> <i>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</i></p> <p>10 Field Studies 178<br /> <i>David W. Kaufman</i></p> <p>11 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives 190<br /> <i>Brian L. Strom</i></p> <p><b>Part III Special Issues in PharmacoepidemiologyMethodology 203</b></p> <p>12 Validity of Pharmacoepidemiologic Drug and Diagnosis Data 205<br /> <i>Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole</i></p> <p>13 Assessing Causality of Case Reports of Suspected Adverse Events 228<br /> <i>Judith K. Jones</i></p> <p>14 Molecular Pharmacoepidemiology 239<br /> <i>Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck</i></p> <p>15 Bioethical Issues in Pharmacoepidemiologic Research 256<br /> <i>Antoine C. El Khoury</i></p> <p>16 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies 269<br /> <i>Samuel M. Lesko and Allen A. Mitchell</i></p> <p>17 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals 280<br /> <i>Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed</i></p> <p>18 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research 291<br /> <i>Holger J. Sch€unemann, Bradley C. Johnston, Roman Jaeschke, and Gordon H. Guyatt</i></p> <p>19 The Use of Meta-analysis in Pharmacoepidemiology 300<br /> <i>Jesse A. Berlin and M. Soledad Cepeda</i></p> <p>20 Studies of Medication Adherence 314<br /> <i>Trisha Acri and Robert Gross</i></p> <p>21 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies 324<br /> <i>Sebastian Schneeweiss and Samy Suissa</i></p> <p><b>Part IV Special Applications 337</b></p> <p>22 Special Applications of Pharmacoepidemiology 339<br /> <i>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</i></p> <p>23 The Future of Pharmacoepidemiology 407<br /> <i>Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy</i></p> <p>Appendix A—Sample Size Tables 417</p> <p>Appendix B—Glossary 435</p> <p>Index 445</p> <p> </p>

<p><b>Edited by</b><br /><b>Brian L. Strom, MD, MPH</b><br />Executive Vice Dean for Institutional Affairs, George S. Pepper Professor of Public Health<br />and Preventive Medicine, Professor of Biostatistics and Epidemiology, of Medicine, and<br />of Pharmacology, Center for Clinical Epidemiology and Biostatistics, Center for<br />Pharmacoepidemiology Research and Training, Perelman School of Medicine at the<br />University of Pennsylvania, Philadelphia, PA, USA</p> <p><b>Stephen E. Kimmel, MD, MSCE</b><br />Professor of Medicine and of Epidemiology, Center for Clinical Epidemiology and<br />Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School<br />of Medicine at the University of Pennsylvania, Philadelphia, PA, USA</p> <p><b>Sean Hennessy, PharmD, PhD</b><br />Associate Professor of Epidemiology and of Pharmacology, Center for Clinical Epidemiology<br />and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School<br />of Medicine at the University of Pennsylvania, Philadelphia, PA, USA</p>

<p><i>Textbook of Pharmacoepidemiology,</i> Second Edition, provides an introduction to pharmacoepidemiology and the data sources, methods and applications used in clinical research, the pharmaceutical industry<br />and regulatory agencies.</p> <p>Drawing upon the fifth edition of the authoritative reference, <i>Pharmacoepidemiology</i>, this new edition covers the key learning requirements of the discipline. The textbook provides an introduction to<br />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.</p> <p><i>Textbook of Pharmacoepidemiology</i> 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.</p>

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