Core--Pharmacokinetics and Dosimetry

University Of California At Davis, Davis CA

Investigators

Linked publications & trials

Abstract

The goal of this core is to provide the experimental design, measurements, software tools, and analysis to determine whether a new drug should progress to the next stage of animal/patient testing. To accomplish this, we provide or organ-scale pharmacokinetics and radiation dosimetry. We rely on the substantial body of work that has already been developed, building on our long-standing track record in developing pharmacokinetics and treatment planning systems and methods, and implementing them in clinical trials. Because the new agents being developed here have never been assessed, establishing their pharmacokinetics in mice is of primary importance. Core researchers have worked and will work in concert with the Project investigators and biostatistician to design each mouse (and later patient) trial to optimize its value for the specific targeting approach being studied. Examples of these contributions and interactions are reflected in the Study Designs for mouse pharmacokinetics and radiation dosimetry in the projects. Because of the need to simplify the Study Design for TNKase intervention in the third project, we modeled available mouse and patient pharmacokinetic data. We found that intervention could improve the therapeutic index by 2-3 times and that there was a range of times over which most of this improvement could be achieved; the latter finding greatly simplified the Study Design. As agent testing moves from mice to patients, we will increase our emphasis on patient dosimetry and pharmacokinetics.