Title
Development of good modelling practice for physiologically based pharmacokinetic models for use in risk assessment: The first steps
Author
Loizou, G.
Spendiff, M.
Barton, H.A.
Bessems, J.
Bois, F.Y.
d'Yvoire, M.B.
Buist, H.
Clewell III, H.J.
Meek, B.
Gundert-Remy, U.
Goerlitz, G.
Schmitt, W.
TNO Kwaliteit van Leven
KvL
Publication year
2008
Abstract
The increasing use of tissue dosimetry estimated using pharmacokinetic models in chemical risk assessments in various jurisdictions necessitates the development of internationally recognized good modelling practice (GMP). These practices would facilitate sharing of models and model evaluations and consistent applications in risk assessments. Clear descriptions of good practices for (1) model development i.e., research and analysis activities, (2) model characterization i.e., methods to describe how consistent the model is with biology and the strengths and limitations of available models and data, such as sensitivity analyses, (3) model documentation, and (4) model evaluation i.e., independent review that will assist risk assessors in their decisions of whether and how to use the models, and also model developers to understand expectations for various purposes e.g., research versus application in risk assessment. Next steps in the development of guidance for GMP and research to improve the scientific basis of the models are described based on a review of the current status of the application of physiologically based pharmacokinetic (PBPK) models in risk assessments in Europe, Canada, and the United States at the International Workshop on the Development of GMP for PBPK Models in Greece on April 27-29, 2007. Crown Copyright © 2008.
Subject
Health
Good modelling practice
PBPK
Risk assessment
article
Canada
documentation
dosimetry
Europe
Greece
priority journal
risk assessment
scientific literature
United States
Animals
Humans
Legislation, Drug
Models, Statistical
Pharmacokinetics
Quantitative Structure-Activity Relationship
Risk Assessment
To reference this document use:
http://resolver.tudelft.nl/uuid:23b11ef3-6363-46d6-8156-7a3e8dbc5767
DOI
https://doi.org/10.1016/j.yrtph.2008.01.011
TNO identifier
240748
ISSN
0273-2300
Source
Regulatory Toxicology and Pharmacology, 50 (3), 400-411
Document type
article