Chapter 16 - Risk Assessment

Abstract

Risk assessment is the systematic analysis of scientific data to characterize the potential adverse health effects resulting from animal or human exposure to drugs, medical devices, chemicals, or any hazardous agents or situations. Classical risk assessment typically is a well-defined four step process and includes hazard identification, dose–response evaluation, exposure assessment, and risk characterization. Although the toxicologic pathologist can be involved in all four steps of the risk assessment process, their greatest contribution usually resides in hazard identification and dose–response evaluation. Risk assessment relies on a wide variety of data sources of both a qualitative and a quantitative nature. Science-based risk assessment utilizing integrative analysis derived from technological advances has favorably impacted the risk assessment process by providing clarity to a greater understanding of the relevant species and the pathways and mechanisms involved.