US EPA

This report summarizes the information presented at the "Workshop on Biological Data for Pharmacokinetic Modeling and Risk Assessment" held by EPA and the Risk Science Institute on May 23-25, 1988, in Asheville, North Carolina. This report provides a general background of risk assessment and reviews how biological data are used in risk assessment and the ways pharmacokinetic modeling can reduce the uncertainties in risk assessment. Different biological models and their value are described, and the differences between predictive models are explained. The report reviews the development and history of pharmacokinetic models, the strengths and limitations of the models, the types of biological data necessary to use pharmacokinetic models, and the role of sensitivity analysis in incorporating pharmacokinetic data into risk assessment. Hepatic metabolism data is used as an example of incorporating in vitro and in vivo data into pharmacokinetic models. Two approaches used for cross-species scaling are included, as well as biotransormation and the correlation of in vitro and vivo data. Actual case studies showing pharmacokinetic modeling used in risk assessment are also described, and research needs are identified.

U.S. EPA. BIOLOGICAL DATA FOR PHARMACOKINETIC MODELING AND RISK ASSESSMENT. U.S. Environmental Protection Agency, Washington, D.C., EPA/600/3-90/019 (NTIS PB90187238), 1990.