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The file was current when produced, but is no longer maintained and may now be outdated.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 Risk Webmaster for assistance.
Please use the contact us form if you need additional support.
Overview
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.
- 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
History/Chronology
| Date | Description |
|---|---|
| 2003 | EPA award released a solicitation for a contract to develop a report for the "Application of Physiologically Based Pharmacokinetic Data and Models in Risk Assessment." |
| 2004 | A draft document was released for internal review. |
| Jul 2005 | EPA released the external review draft for public comment and peer review |
| Nov 2005 | A draft of this report was subjected to an external review by a panel of independent experts. |
Status
Once this is done, the final report, which addresses both public and peer review comments, will be published and available from the EPA Web site.
Download(s)
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.
- Approaches For The Application Of Physiologically Based Pharmacokinetic (Pbpk) Models And Supporting Data In Risk Assessment - 2005 External Peer Review (PDF) (110 pp, 997.1 KB, about PDF)
- Appendix 1: Algorithims for Predicting Chemical-Specific Parameters for PBPK Models (PDF) (17 pp, 272.5 KB, about PDF)
- Appendix 2: List of Publications Relevant to PBPK Modeling of Environmental Chemicals and it's Use (PDF) (90 pp, 381.8 KB, about PDF)
- Appendix 3: Partition Coefficients and Metabolic Rate Constants for PBPK Modeling of Environmental Chemicals (PDF) (147 pp, 2.5 MB, about PDF)
- Summary Report of the Panel Peer Review Discussion of the PBPK Document (PDF) (19 pp, 115.2 KB, about PDF)
- Disposition of Comments from the PBPK Peer-Review (PDF) (11 pp, 60.5 KB, about PDF)
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.