chapter  2
19 Pages

Risk Assessment of New Drugs, Pharmacoepidemiology, and Regulatory Decisionmaking

WithRobert C. Nelson

The safety or risk assessment of a pharmacotherapeutic agent begins early in its development, matures during its premarketing clinical evaluation, 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. Drugs make up the only group of chemicals that are deliberately used or are administered at doses intended to have an effect on the body. A drug is biologically active and can be expected to be toxic at some dose. In initial evaluation should take into account the known structural, biochemical, and pharmacologic properties as well as all information, experimental or epidemiologic, domestic or foreign, which can be obtained from similar or related compounds. In drug development, toxicology and other types of preclinical studies precede and then interdigitate with the clinical investigation.