Title: Development of Good Modelling Practice for Physiologically Based Pharmacokinetic Models for Use in Risk Assessment: The First Steps
Authors: LOIZOU GeorgeSPENDIFF MartinBARTON HughBESSEMS JosBOIS Frederic YvesBOUVIER D'YVOIRE MICHELBUIST HarrieCLEWELL III HarveyMEEK BetteGUNDERT-REMY UrsulaGOERLITZ GerhardSCHMITT Walter
Citation: REGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 50 no. 3 p. 400-411
Publisher: ACADEMIC PRESS INC ELSEVIER SCIENCE
Publication Year: 2008
JRC N°: JRC40435
ISSN: 0273-2300
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC40435
DOI: 10.1016/j.yrtph.2008.01.011
Type: Articles in Journals
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.
JRC Institute:Institute for Health and Consumer Protection

Files in This Item:
There are no files associated with this item.


Items in repository are protected by copyright, with all rights reserved, unless otherwise indicated.