Physiological Parameters Database for PBPK Modeling (External Review Draft)
Note: EPA has updated this document, but this version is provided as a courtesy to the public as a matter of public record.
Federal Register Notices
Contact
- Bob Sonawane
- by phone at: 703-347-8556
- by email at: sonawane.bob@epa.gov
Notice
EPA is releasing an ACCESS database file containing physiological parameter data intended to be suitable for application with PBPK modeling. This was announced in the April 16, 2009 Federal Register Notice. The public review and comment period will be for 30 days. EPA requests that interested users comment on the functionality or usability of this resource and provide comments that may be considered for improving the final product.
EPA released for public comment a physiological parameters database (created using Microsoft ACCESS) intended to be used in PBPK modeling. The database contains physiological parameter values for humans from early childhood through senescence. It also contains similar data for animals (primarily rodents). This information (contained in this database) was collected through extensive search and contains physiological parameter data for humans from infancy through old age, as well as data for experimental laboratory species. To date, roughly 30% of the data entries have been verified by an independent contractor as a means of quality assurance and quality control (QA/QC). Because the QA/QC process will be ongoing during the public comment period, EPA requests that end-users focus on providing feedback regarding their experience working with the database, and not try duplicating efforts to QA the database. Users are also welcome to comment on specific studies or methods employed in the studies included in the database if desired.The PBPK Modeling Database is available for download as a compressed Microsoft ACCESS file. To open the compressed file, first save the file on your hard drive, and unzip the contents into a folder of your choosing.
Background
As an important class of dosimetry models, PBPK models are useful for predicting internal dose at target organs for risk assessment applications. Dose-response relationships that appear unclear or confusing at the administered dose level can become more understandable when expressed on the basis of internal dose of the chemical. To predict internal dose level, PBPK models use physiological data to construct mathematical representations of biological processes associated with the absorption, distribution, metabolism, and elimination of compounds. With the appropriate data, these models can be used to extrapolate across species, lifestages, and exposure scenarios, as well as address various sources of uncertainty in risk assessments. This database contains a collection of physiological data relevant for parameterizing PBPK models for children, adults, and the elderly. In addition, the database contains physiological data for parameterizing PBPK models for young (i.e., developing) and adult rodents.
History/Chronology
| 2005 | EPA released a Request for Proposals (RFQ PR-DC-05-01981) to develop a database of physiological parameters in the aged/elderly population. |
| 2006 | An ACCESS database was delivered under an independent contract and subsequently modified by EPA prior to its current release. |
| Feb 2008 | EPA released the Physiological Parameters Database for Older Adults (Beta 1.0) to the public for review and comment. |
| Dec 2008 | EPA released a revised Physiological Parameters Database for Older Adults (Beta 1.1) to the public for review and comment. |
| Apr 2009 | EPA released a revised Physiological Parameters Database to the public for review and comment. |
Next Steps
Downloads/Related Links
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.
- Physiological Parameters Database (Access)
- Database Field Descriptions (PDF) (6 pp, 113 KB, about PDF)
Related Link(s)
Additional Information
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