Full metadata record
DC FieldValueLanguage
dc.contributor.authorLOIZOU Georgeen_GB
dc.contributor.authorSPENDIFF Martinen_GB
dc.contributor.authorBARTON Hughen_GB
dc.contributor.authorBESSEMS Josen_GB
dc.contributor.authorBOIS Frederic Yvesen_GB
dc.contributor.authorBOUVIER D'YVOIRE MICHELen_GB
dc.contributor.authorBUIST Harrieen_GB
dc.contributor.authorCLEWELL III Harveyen_GB
dc.contributor.authorMEEK Betteen_GB
dc.contributor.authorGUNDERT-REMY Ursulaen_GB
dc.contributor.authorGOERLITZ Gerharden_GB
dc.contributor.authorSCHMITT Walteren_GB
dc.date.accessioned2010-02-25T15:44:41Z-
dc.date.available2008-09-18en_GB
dc.date.available2010-02-25T15:44:41Z-
dc.date.created2008-09-16en_GB
dc.date.issued2008en_GB
dc.date.submitted2007-09-27en_GB
dc.identifier.citationREGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 50 no. 3 p. 400-411en_GB
dc.identifier.issn0273-2300en_GB
dc.identifier.urihttp://publications.jrc.ec.europa.eu/repository/handle/JRC40435-
dc.description.abstractThe 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.en_GB
dc.description.sponsorshipJRC.I.2-In-vitro Toxicologyen_GB
dc.format.mediumPrinteden_GB
dc.languageENGen_GB
dc.publisherACADEMIC PRESS INC ELSEVIER SCIENCEen_GB
dc.relation.ispartofseriesJRC40435en_GB
dc.titleDevelopment of Good Modelling Practice for Physiologically Based Pharmacokinetic Models for Use in Risk Assessment: The First Stepsen_GB
dc.typeArticles in periodicals and booksen_GB
dc.identifier.doi10.1016/j.yrtph.2008.01.011en_GB
JRC Directorate:Institute for Health and Consumer Protection Historical Collection

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.