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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)
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.
Impact/Purpose:
This report is intended to serve as a reference document for risk assors to use when quantifying, extrapolating, and interpretating advanced biochemical information about human interindividual variability of chemical metabolism.
Description:
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.