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RECORD NUMBER: 22 OF 227

Main Title Approaches for the application of physiologically based pharmacokinetic (PBPK) models and supporting data in risk assessment.
CORP Author Environmental Protection Agency, Washington, DC. National Center for Environmental Assessment.
Publisher National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency,
Year Published 2006
Report Number EPA/600/R-05/043F
Stock Number PB2007-106632
OCLC Number 99471710
Additional Subjects Risk assessment ; PBPK models ; Target organs ; Internal dose ; Dosimetry modeling ; Physiologically based pharmacokinetic (PBPK) models
Internet Access
Description Access URL
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=157668
https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=600007U5.PDF
http://oaspub.epa.gov/eims/eimscomm.getfile?p_download_id=458188
Holdings
Library Call Number Additional Info Location Last
Modified
Checkout
Status
EHBD  EPA/600/R-05/043F CEMM/ACESD Library/Narragansett,RI 05/04/2007
EJBD  EPA 600-R-05-043F Headquarters Library/Washington,DC 03/30/2007
EKBD  EPA-600/R-05-043F Research Triangle Park Library/RTP, NC 03/30/2007
EKCD  EPA/600/R-05/043F CEMM/GEMMD Library/Gulf Breeze,FL 04/13/2011
ELBD ARCHIVE EPA 600-R-05-043F Received from HQ AWBERC Library/Cincinnati,OH 10/04/2023 DISPERSAL
ELCD  EPA/600/R-05/043F NVFEL Library/Ann Arbor, MI 05/18/2007
EMAD  EPA/600/R-05/043F Region 6 Library/Dallas,TX 12/27/2011 DISPERSAL
EMBD  EPA/600/R-05/043F NRMRL/GWERD Library/Ada,OK 03/26/2012
ERAD  EPA 600/R-05-043F Region 9 Library/San Francisco,CA 04/20/2007
ESAD  EPA 600-R-05-043F Region 10 Library/Seattle,WA 06/29/2007
NTIS  PB2007-106632 Some EPA libraries have a fiche copy filed under the call number shown. 07/26/2022
Collation 1 v. (various pagings) : ill. ; 28 cm.
Abstract
The objective of this document is to provide a description of approaches for using physiologically based pharmacokinetic (PBPK) data and models in human health risk assessment. Its primary focus is on the evaluation and use of PBPK models for predicting internal dose at target organs in risk assessment applications. Many of the past efforts on PBPK modeling have focused on water-insoluble gases that cause systemic toxicity (i.e., producing effects remote from the site of exposure) and on some nonvolatile organics. This document primarily draws on the experience and literature resulting from these efforts. These approaches can also be applied to agents such as reactive gases and particulate matter where the target organ is the respiratory tract, generally in conjunction with specialized respiratory tract modeling (e.g., computational fluid dynamic modeling). Guidance concerning alternative approaches to dosimetry modeling should also be consulted for determining a reference concentration (RfC) value (U.S. EPA, 1994). The discussions herein are conceptually applicable, in a broad sense, to many kinds of dosimetry models and a wide range of substances. In developing this document, it was assumed that risk assessors are familiar with some basic concepts of pharmacokinetics and that model developers are familiar with some of the basic concepts of risk assessment; therefore, the document serves as an overview of PBPK modeling and its application in risk assessment. Appropriate references to secondary review articles and reports from which additional information can be obtained are provided. Finally, it is important to realize that the application of PBPK models in risk assessment is evolving. Thus, this document does not specify (or recommend) when the effort to construct and apply PBPK modeling is justified; rather, it highlights some of the benefits of PBPK modeling in risk assessment.
Notes
August 2006. Includes bibliographical references (p. R1-R17)