Strom B.L., Kimmel S.E., Hennessy S. Pharmacoepidemiology

New York: Wiley-Blackwell, 2019. — 1192 p.This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.What is Pharmacoepidemiology?
Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies.
Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies.
Sample Size Considerations for Pharmacoepidemiologic Studies.
When Should One Perform Pharmacoepidemiologic Studies?
The Role of Pharmacoepidemiology in Different Sectors.
The Role of Pharmacoepidemiology in the Healthcare System and Academia.
The Role of Pharmacoepidemiology in Industry.
The Role of Pharmacoepidemiology in Regulatory Agencies.
Pharmacoepidemiology and the Law.
Sources of Data for Pharmacoepidemiology Research.
Spontaneous Reporting.
Postmarketing Spontaneous Pharmacovigilance Reporting Systems.
Electronic Data Systems.
Overview of Electronic Databases in Pharmacoepidemiology.
Encounter Databases.
Electronic Health Record Databases.
Inpatient Databases.
Studies Involving Ad Hoc Data Collection.
Event Monitoring in the UK.
Primary Data Collection for Pharmacoepidemiology.
Choosing a Data Source.
Choosing among the Available Data Sources for Pharmacoepidemiology Research.
Selected Applications of Pharmacoepidemiology.
Studies of Drug Utilization.
Evaluating and Improving Physician Prescribing.
Pharmacoepidemiologic Studies of Vaccine Safety.
Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices.
Research on the Effects of Medications in Pregnancy and in Children.
Study of Biologics and Biosimilars.
Risk Management.
Distributed Networks of Databases Analyzed Using Common Protocols and/or Common Data Models.
Comparative Effectiveness Research.
Data Mining and Other Informatics Approaches to Pharmacoepidemiology.
Pharmacoepidemiologic Research on Drugs of Abuse.
Selected Special Methodologic Issues in Pharmacoepidemiology.
Assessing Causation from Case Reports.
Molecular Pharmacoepidemiology.
Bioethical Issues in Pharmacoepidemiologic Research.
The Use of Randomized Controlled Trials in Pharmacoepidemiology.
The Use of Pharmacoepidemiology to Study Beneficial Drug Effects.
Pharmacoeconomics: The Economics of Pharmaceuticals.
Benefit–Risk Assessments of Medical Treatments.
The Use of Metaanalysis in Pharmacoepidemiology.
Validity of Drug and Diagnosis Data in Pharmacoepidemiology.
Studies of Medication Adherence.
Risk Evaluation and Communication.
Methods for Studying the Health Effects of Drug–Drug Interactions.
The Pharmacoepidemiology of Medication Errors.
Patient Engagement and Patient‐Reported Outcomes.
Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies.The Future of Pharmacoepidemiology.
Appendix A Sample Size Tables.
Appendix B Glossary.