Objective

A key step in drug development is the projection of anticipated effective dose and dose regimen. Often the data available prior to Phase 1 clinical trials are derived from in vitro or animal species experiments and may be sparse. Nevertheless, having the best possible estimate of dose and regimen prior to Phase 1 can be useful as this can facilitate the early assessment of the feasibility of a positive outcome or improve the design of clinical trials by providing a target dose. PKTool is a free utilitarian software that has been developed to help drug discoverers simulate clinical scenarios using preclinical in vitro and in vivo PKPD data. The theory behind the extrapolation methods will be described and use case examples will be discussed.