ABSTRACT
This chapter discusses the process of risk assessment formalized by the National Research Council. It then describes some common approaches to quantitative risk assessment and focuses on the critical stage of dose-response evaluation where statistical models play a key role in the quantification of risk, and the crucial choice of the model has a fundamental role in risk estimation. The method of risk assessment in toxicology depends on the endpoint. There are generally two approaches taken depending on whether the endpoint is cancer or non-cancer. Moreover, the approaches for quantitative derivation of risk depend on whether or not the response of interest is quantal or quantitative. The outcome of interest in many toxicological studies is qualitative in nature. The process of risk assessment when the response of interest in the experiment is quantitative begins by first fitting an appropriate dose-response model.
