Jump to main content
US EPA
United States Environmental Protection Agency
Search
Search
Main menu
Environmental Topics
Laws & Regulations
About EPA
Health & Environmental Research Online (HERO)
Contact Us
Print
Feedback
Export to File
Download
Search:
This record has one attached file:
Add More Files
Attach File(s):
Display Name for File*:
Save
Citation
Tags
HERO ID
4326432
Reference Type
Technical Report
Subtype
EPA Report
Title
An umbrella Quality Assurance Project Plan (QAPP) for PBPK models
Author(s)
U.S. Environmental Protection Agency :: U.S. EPA
Year
2018
Is Peer Reviewed?
Yes
Publisher
U.S. Environmental Protection Agency
Location
Research Triangle Park, NC
Report Number
ORD QAPP ID No: B-0030740-QP-1-1
Number of Pages
22
Language
English
Relationship(s)
is related to other part(s)
7326125
Umbrella quality assurance project plan (QAPP) for dosimetry and mechanism-based models
Abstract
The U.S. Environmental Protection (EPA) Agency requires project managers and planners to develop a Quality Assurance Project Plan (QAPP) as a tool for documenting the type and quality of data and model information that are needed for making environmental decisions. This document provides a QAPP that covers the basic data collection and modeling methodologies for physiologicallybased pharmacokinetic (PBPK) models. It is an “Umbrella” QAPP and intended to be applicable to multiple PBPK modeling projects. This QAPP conforms to EPA QA/G-5 (U.S. EPA, 2002a) and is an internal QA Project Plan in support of the U.S. EPA’s Human Health Risk Assessment (HHRA) research plan.
A PBPK model is a mathematical representation that describes the disposition of one or more chemicals in the body of a human or experimental animal in which organs or tissue groups are represented as compartments linked by blood flow that carries the chemical(s) between compartments. Put another way, a PBPK model is a quantitative statement of a set of hypotheses regarding the major determinants of absorption, distribution, metabolism and excretion (ADME). A key advantage of these models is that they can be used for various types of extrapolation including cross-species (animal to human), cross-route (e.g. inhalation to oral), and among exposure scenarios (Krishnan and Andersen, 1994), all of which can be used to facilitate human health risk evaluation and the setting of regulatory exposure levels. In addition to PBPK models, simpler pharmacokinetic (PK) with more empirically derived parameters can be used for the same types of extrapolation. Either form of PK model (PBPK models being a subset of all PK models) can be linked to a model describing some level of biological response, in which the combined dosimetry-response model is referred to as a biologically-based doseresponse (BBDR) model. In this QAPP the term “PBPK” will be used since it is presently the most commonly evaluated and applied model form of model expected to be evaluated and used. However, this QAPP is intended to apply equally well to classical PK and BBDR model forms.
Guidance on the use or application of PBPK models in U.S. EPA risk assessments is not the subject of this document, but can be found in U.S. EPA (2006).
Tags
IRIS
•
Chloroprene
•
Chromium VI
Not in Lit Search
•
Ethylbenzene
Protocol template references
•
Inorganic Mercury Salts (2)
Litcite References – Protocol
•
Methylmercury
Cited in Document
•
Naphthalene
•
Nitrate/Nitrite
Other resources cited in assessment
•
PCBs
IRIS assessment protocol template
•
Uranium Toxicological Review
Additional Strategies
•
Vanadium Inhalation
Cited in Protocol
IRIS Legacy
•
Naphthalene – Acute (2022)
•
PFBA
Protocol References
•
PFHxS
Other
•
Naphthalene (2021 Evidence mapping publication)
Home
Learn about HERO
Using HERO
Search HERO
Projects in HERO
Risk Assessment
Transparency & Integrity