Drug Epidemiology and Post-Marketing Surveillance

Section A Spontaneous Reporting.- The Analysis of Postmarketing Drug Surveillance Data at the U.S. Food and Drug Administration.- Postmarketing Surveillance of ADRs by Spontaneous Reporting and Register Data: The Swedish Approach.- Spontaneous Monitoring of Adverse Reactions to Drugs, Procedures, and Experiences in the Netherlands.- Pharmacovigilance in France: A Decentralized Approach.- Section B Traditional Clinical Epidemiology Methods as Applied to Pharmacoepidemiology.- The Use of Vital and Morbidity Statistics for the Detection of Adverse Drug Reactions and for Monitoring of Drug Safety.- The Use of Case-Control Studies in Pharmacoepidemiology.- The Use of Cohort Studies in Pharmacoepidemiology.- Using Randomized Trials in Pharmacoepidemiology.- Section C Use of Automated Databases for Pharmacoepidemiology.- Pharmacoepidemiology Studies Using Large Databases.- Screening for Unknown Effects of Newly Marketed Drugs.- Section D Hospital Pharmacoepidemiology.- Hospital Data Sources.- Hospital-Based Intensive Cohort Studies.- Hospital-Based Adverse Reaction and Drug Utilization Review in the United States.- Section E New Methodologic Developments.- Approaches to Evaluating Causation of Suspected Drug Reactions.- Pharmacoeconomics: Principles and Basic Techniques of Economic Analysis.- N of 1 Randomized Trials for Investigating New Drugs.- Measuring Health-Related Quality of Life in Clinical Trials.- Section F Selected Examples of Regulatory and Commercial Importance.- Evaluation of Bias and Validation of Survival Estimates in a Large Cohort of AIDS Patients Treated with Zidovudine.- The Triazolam Experience in 1979 in The Netherlands, a Problem of Signal Generation and Verification.- Contributors.