US EPA

Mode-of-action based risk and safety assessments can rely upon tissue dosimetry estimates in animals and humans obtained from physiologically-based pharmacokinetic (PBPK) modeling. However, risk assessment also increasingly requires characterization of uncertainty and variability; such characterization for PBPK model predictions represents a continuing challenge to both modelers and users. Current practices show significant progress in specifying deterministic biological models and the non-deterministic (often statistical) models, estimating their parameters using diverse data sets from multiple sources, and using them to make predictions and characterize uncertainty and variability.

BARTON, H. A., W. CHIU, R. W. SETZER, M. E. Andersen, A. J. Bailer, F. Y. Bois, R. S. DeWoskin, S. Hays, G. Johanson, N. Jones, G. Loizou, C. Portier, M. Spendiff, AND Y. Tan. Characterizing Uncertainty and Variability in PBPK Models: State of the Science and Needs for Research and Implementation. TOXICOLOGICAL SCIENCES. Society of Toxicology, RESTON, VA, 99(2):395-402, (2007).

• Characterizing Uncertainty and Variability in Physiologically Ba 

If you have a disability and the format of any material on our web pages interferes with your ability to access the information, please reach out to us using the Contact us about IRIS form for assistance. To enable us to respond in a manner most helpful to you, please indicate the nature of the accessibility problem, the web address of the requested material, your preferred format in which you want to receive the material (electronic format (ASCII, etc.), standard print, large print, etc.), and your contact information.

• Systems Modeling of Prostate Regulation and Response to Antiandrogen