Drug safety, pharmacoepidemiology, and regulatory decision making.
The safety or risk assessment of a pharmacotherapeutic agent begins early in its development and continues throughout its use cycle. The practice of pharmacoepidemiology is the art of using the sciences and the tools of science to generate information about pharmaceutical outcomes, including associated risks, in the postmarketing environment. A pharmacoepidemiologist must be capable of functioning with a matrix constructed of three components: a knowledge base, a conceptual framework, and an interpretive framework. From this perspective one can establish surveillance schemes, or understand a posed research question, select strategies, apply methodologies, and interpret the results of purposeful investigations. When conveyed to the risk manager, appropriately interpreted results of a properly conducted risk assessment can be used in regulatory decision making. Seven case studies are presented as examples of this approach.
Nelson
R C
RC
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857.
D003657:Decision Making; D064420:Drug-Related Side Effects and Adverse Reactions; D004812:Epidemiologic Methods; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D011358:Product Surveillance, Postmarketing; D013375:Substance Withdrawal Syndrome; D014481:United States; D014486:United States Food and Drug Administration