Read more
Informationen zum Autor Edited byBrian L. Strom, MD, MPHExecutive Vice Dean for Institutional Affairs, George S. Pepper Professor of Public Healthand Preventive Medicine, Professor of Biostatistics and Epidemiology, of Medicine, andof Pharmacology, Center for Clinical Epidemiology and Biostatistics, Center forPharmacoepidemiology Research and Training, Perelman School of Medicine at theUniversity of Pennsylvania, Philadelphia, PA, USAStephen E. Kimmel, MD, MSCEProfessor of Medicine and of Epidemiology, Center for Clinical Epidemiology andBiostatistics, Center for Pharmacoepidemiology Research and Training, Perelman Schoolof Medicine at the University of Pennsylvania, Philadelphia, PA, USASean Hennessy, PharmD, PhDAssociate Professor of Epidemiology and of Pharmacology, Center for Clinical Epidemiologyand Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman Schoolof Medicine at the University of Pennsylvania, Philadelphia, PA, USA Klappentext Textbook of Pharmacoepidemiology, Second Edition, provides an introduction to pharmacoepidemiology and the data sources, methods and applications used in clinical research, the pharmaceutical industryand 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 topharmacoepidemiology, 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. Zusammenfassung Textbook of Pharmacoepidemiology! Second Edition! provides an introduction to pharmacoepidemiology and the methodologies! data sources and applications used in clinical practice! the pharmaceutical industry and regulatory agencies. Inhaltsverzeichnis Preface, xiiiAcknowledgements, xviiPart I Introduction to Pharmacoepidemiology 11 What is Pharmacoepidemiology? 3Brian L. Strom2 Study Designs Available for Pharmacoepidemiologic Studies 17Brian L. Strom3 Sample Size Considerations for Pharmacoepidemiologic Studies 30Brian L. Strom4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies 40Jeffrey S. Barrett and Athena F. Zuppa5 When Should One Perform Pharmacoepidemiologic Studies? 54Brian L. Strom6 Views from Academia, Industry, Regulatory Agencies, and the Legal System 63Jerry Avorn, Jingping Mo, Robert F. Reynolds, Gerald J. Dal Pan, Peter Arlett, and Aaron S. KesselheimPart II Sources of Pharmacoepidemiology Data 997 Postmarketing Spontaneous Pharmacovigilance Reporting Systems 101Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin8 Overview of Automated Databases in Pharmacoepidemiology 118Brian L. Strom9 Examples of Existing Automated Databases 123Sengwee 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 Pedersen10 Field Studies 178David W. Kaufman11 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives 190Brian L. StromPart III Special Issues in PharmacoepidemiologyMethodology 20312 Validity of Pharmacoepidemiologic Drug and Diagnosis Data 205Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole13 Assessing Causality of Case Reports of Suspected...
