Key words: risk assessment, route-to-route extrapolation, duration of exposure, interspecies extrapolation, tech support
CDRH staff are often asked to make regulatory decisions based on little available data. For example, toxicological data are often unavailable from clinically relevant routes or durations of exposure to derive protective health based exposure limits (HBELs) for compounds released from medical device materials. Toxicological data are also often unavailable for the species of clinical interest - humans. As a result, the need exist to develop tools that will allow Center staff to extrapolate toxicological results obtained following administration via one route of exposure to those expected from another route, from one duration of exposure to another and from one species to another. Work is ongoing in OST to develop and validate approaches to allow each of these extrapolation procedures to be done.