Use Of Physiologically Based Pharmacokinetic (PBPK) Models To Quantify The Impact Of Human Age And Interindividual Differences In Physiology And Biochemistry Pertinent To Risk (Final Report)

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Overview

EPA announced the availability of the final report, Use of Physiologically Based Pharmacokinetic (PBPK) Models to Quantify the Impact of Human Age and Interindividual Differences in Physiology and Biochemistry Pertinent to Risk Final Report for Cooperative Agreement. This report describes and demonstrates techniques necessary to extrapolate and incorporate in vitro derived metabolic rate constants in PBPK models. It also includes two case study examples designed to demonstrate the applicability of such data for health risk assessment and addresses the quantification, extrapolation and interpretation of advanced biochemical information on human interindividual variability of chemical metabolism for risk assessment application. It comprises five chapters; topics and results covered in the first four chapters have been published in the peer reviewed scientific literature.

Topics covered include:

Data Quality Objectives
Experimental Framework
Required Data
Two example case studies that develop and incorporate in vitro metabolic rate constants in PBPK models designed to quantify human interindividual variability to better direct the choice of uncertainty factors for health risk assessment.

Citation

U.S. EPA. Use Of Physiologically Based Pharmacokinetic (PBPK) Models To Quantify The Impact Of Human Age And Interindividual Differences In Physiology And Biochemistry Pertinent To Risk (Final Report). U.S. Environmental Protection Agency, Washington, D.C., EPA/600/R-06/014A.

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Background

This report is the result of Cooperative Agreement CR828047010 between US EPA/ORD/NCEA and the Chemical Industry Institute for Toxicology(CIIT) and Dr Gregory Kedderis.

History/Chronology

Date	Description
01- 2002/03	Chapters 1-4 results were published in peer reviewed literature.
02- Jul 2004	A draft of Chapter 5 was released for internal review.
03- Oct 2004	A draft of Chapter 5 released for external review.
04- Dec 2004	Simplified acquisition developed to refine the final case study (Chapter 5).
05- Jun 2005	A draft of the full document was subjected to peer consultation.
06- Apr 2006	EPA released the final report.

Status

This is the final document. Results from Chapter 5 (the final case study) will be published in the peer reviewed literature.

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Download(s)

This document has been reviewed in accordance with U.S. Environmental Protection Agency policy and approved for publication. Mention of trade names or commercial products does not constitute endorsement or recommendation for use.

Use of Physiologically Based Pharmacokinetic Models to Quantify the Impact of Human Age and Interindividual Differences in Physiology and Biochemistry Pertinent to Risk (PDF) (234 pp, 3.1 MB, about PDF)

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