Science Inventory

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

Citation:

U.S. EPA. Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment (External Review Draft 2005). U.S. Environmental Protection Agency, Washington, D.C., EPA/600/R-05/043A, 2005.

Impact/Purpose:

This report is primarily meant to serve as a learning tool for EPA scientists and risk assessors who may be less familiar with the field. In addition, this report can be informative to PBPK modelers within and outside the Agency, as it provides an assessment of the types of data and models that the EPA requires for consideration of a model for use in risk assessment.

Description:

This draft report of Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment addresses the application and evaluation of PBPK models for risk assessment purposes. These models represent an important class of dosimetry models that are useful for predicting internal dose at target organs for risk assessment applications.

Topics covered include:

  • 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.
In addition, appendices are provided that include
  • a compilation of chemical partition coefficients and rate constants,
  • algorithms for estimating chemical-specific parameters, and
  • a list of publications relating to PBPK modeling.

URLs/Downloads:

FR NOTICE: OCTOBER 14, 2005   Exit

Summary Report of the Panel Peer Review Discussion of the PBPK Document   (PDF, 19 pp,  118 KB,  about PDF)

Appendix 2: List of Publications Relevant to PBPK Modeling of Environmental Chemicals and it's Use   (PDF, 90 pp,  391 KB,  about PDF)

Appendix 1: Algorithims for Predicting Chemical-Specific Parameters for PBPK Models   (PDF, 17 pp,  279 KB,  about PDF)

Disposition of Comments from the PBPK Peer-Review   (PDF, 11 pp,  62 KB,  about PDF)

Approaches For The Application Of Physiologically Based Pharmacokinetic (Pbpk) Models And Supporting Data In Risk Assessment - 2005 External Peer Review   (PDF, 110 pp,  1021 KB,  about PDF)

Appendix 3: Partition Coefficients and Metabolic Rate Constants for PBPK Modeling of Environmental Chemicals   (PDF, 147 pp,  2658 KB,  about PDF)

FR NOTICE: AUGUST 22, 2005   Exit

Record Details:

Record Type: DOCUMENT ( REPORT)
Product Published Date: 07/05/2005
Record Last Revised: 04/03/2017
Record ID: 135427