Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment (External Review Draft 2005)

Note: EPA has updated this document, but this version is provided as a courtesy to the public as a matter of public record.

Notice

Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment (EPA/600/R-05/043A), is an external review draft report. EPA is releasing this report on 7/28/2005 for public review and comment. The public comment period has been extended until 10/14/2005 and written comments should be sent to EPA by this date, as indicated in the August 22 Federal Register Notice. More information about the external peer review workshop from Nov 10-11, 2005 can be found in the October 14 Federal Register Notice.

Comments may be submitted and viewed using EPA's electronic docket (edocket) at www.epa.gov/edocket. Select search and key in the Docket Number ORD-2005-0022 for the document, Approaches for the Application of Physiologically based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment.

• the types of data required use of PBPK models in risk assessment,
• evaluation of PBPK models for use in risk assessment, and
• the application of these models to address uncertainties resulting from extrapolations (e.g. interspecies extrapolation) often used in risk assessment.

• a compilation of chemical partition coefficients and rate constants,
• algorithms for estimating chemical-specific parameters, and
• a list of publications relating to PBPK modeling.

Citation