Bookedited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy.
Summary: "It was a remarkable 32 years ago that the first edition of Strom's Pharmacoepidemiology was published. The preface to that book stated that pharmacoepidemiology was a new field with a new generation of pharmacoepidemiologists arising to join the field's few pioneers. Over the ensuing 32 years, the field indeed has grown and no longer deserves to be called "new." Many of those "new generation" scientists (including two of the editors of this book) are now "middle-aged" pharmacoepidemiologists. Despite its relatively brief academic life, a short history of pharmacoepidemiology and review of its current state will set the stage for the purpose of this textbook. 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 postmarketing medical product surveillance, studies of the effects of medical products (i.e., drugs, biologicals, devices) performed after a product has been approved for use. In recent years, pharmacoepidemiology has expanded to include many other types of studies, as well"-- Provided by publisher.
Contents:
What is Pharmacoepidemiology? / Brian L. Strom
Study Designs Available for Pharmacoepidemiologic Studies / Brian L. Strom
Sample Size Considerations for Pharmacoepidemiologic Studies / Brian L. Strom
Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies / Jeffrey S. Barrett
When Should One Perform Pharmacoepidemiologic Studies? / Brian L. Strom
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
Postmarketing Spontaneous Pharmacovigilance Reporting Systems /
Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin
Overview of Electronic Databases in Pharmacoepidemiology / Brian L. Strom
Encounter Databases / Tobi Gerhard, Yola Moride, Anton Pottegard, Nicole Pratt
Electronic Health Record Databases / Daniel Horton, Harshvinder Bhullar, Francesca Cunningham, Janet Sultana B. Pharm (Hons.), and Gialuca Trifiro
Primary Data Collection for Pharmacoepidemiology / Priscilla Velentgas
How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives / Brian L. Strom
Validity of Drug and Diagnosis Data in Pharmacoepidemiology / Mary Elizabeth Ritchey, Suzanne L West, and George Maldonado
Assessing Causality from Case Reports / Bernard Begaud, and the late Judith K. Jones
Molecular Pharmacoepidemiology / Christine Y Lu and Stephen E. Kimmel
Bioethical Issues in Pharmacoepidemiologic Research / Laura E Bothwell, Annika Richterich, and Jeremy Greene
The Use of Randomized Controlled Trials in Pharmacoepidemiology /
Robert Reynolds, Samuel M. Lesko, Allen A. Mitchell
Pharmacoeconomics: Economic Evaluation of Pharmaceuticals / Kevin A. Schulman
Patient Engagement and Patient Reported Outcomes / Esi Morgan
The Use of Meta-analysis in Pharmacoepidemiology / Jesse A. Berlin, Vrenda J Crowe, H Amy Xia, and Stephen JW Evans
Studies of Medication Adherence / Julie Lauffenburger, Trisha Acri, and Robert Gross
Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies / Sebastian Schneeweiss and Samy Suissa
Special Applications of Pharmacoepidemiology / 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 DiSantostefano, Scott Evans
The Future of Pharmacoepidemiology / Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy.