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

Notice - This site contains archived material(s)

Archive disclaimer
Archived files are provided for reference purposes only. The file was current when produced, but is no longer maintained and may now be outdated. Persons with disabilities having difficulty accessing archived files may contact the NCEA Webmaster for assistance. Please use the contact us form if you need additional support.


This draft report of Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment (PDF, 110pp, 1MB, About PDF) 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.


In summer 2005, there will be a meeting in Washington, DC for the purpose of providing an independent scientific peer review of this document. EPA will issue a separate notice, to be published in the Federal Register, that will give the dates and place of this public meeting. The notice will describe procedures for the public to register, without cost, to attend the meeting and to give written and/or oral comment before the peer review panel. With the completion of the scientific peer review, EPA will review all comments received, including public comments, to finalize the document.

Then the final report, which addresses both public and peer review comments, will be published and available from the NCEA Web site.


2003EPA award releases a solicitation for a contract to develop a report for the Application of Physiologically Based Pharmacokinetic Data and Models in Risk Assessment
2004Draft document released for internal review
2005EPA released the external review draft for public comment and peer review

This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.