Biomaterial Database

Postmarketing surveillance methodologies. 1988

S A Edlavitch

University of Minnesota, Minneapolis 55455.

This article describes and discusses the strengths and limitations of the major pharmacoepidemologic methodologies employed in postmarketing drug surveillance and describes the current status of the U.S. surveillance system. The main methodologies employed in postmarketing drug surveillance include controlled clinical trials, observational epidemiologic studies (cohort, case-control, cross-sectional), demographic methods, drug utilization surveys, spontaneous reports, and automated databases linking medications and disease. Examples of pharmacoepidemiologic studies using each of these methodologies are presented. When a question arises about the efficacy and/or safety of a marketed drug, typically a mixture of these study methodologies is employed. The article concludes with a brief discussion of the role of the Food and Drug Administration, pharmaceutical manufactures, and academic institutions in initiating and conducting postmarketing drug studies.

UI	MeSH Term	Description	Entries
D011358	Product Surveillance, Postmarketing	Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.	Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D005069	Evaluation Studies as Topic	Works about studies that determine the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies.	Critique,Evaluation Indexes,Evaluation Methodology,Evaluation Report,Evaluation Research,Methodology, Evaluation,Pre-Post Tests,Qualitative Evaluation,Quantitative Evaluation,Theoretical Effectiveness,Use-Effectiveness,Critiques,Effectiveness, Theoretical,Evaluation Methodologies,Evaluation Reports,Evaluation, Qualitative,Evaluation, Quantitative,Evaluations, Qualitative,Evaluations, Quantitative,Indexes, Evaluation,Methodologies, Evaluation,Pre Post Tests,Pre-Post Test,Qualitative Evaluations,Quantitative Evaluations,Report, Evaluation,Reports, Evaluation,Research, Evaluation,Test, Pre-Post,Tests, Pre-Post,Use Effectiveness
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.