Title: Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications
Authors: PAINI ALICIALEONARD JEREMY AKLIMENT TOMASTAN CECILIAWORTH ANDREW
Citation: REGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 90 p. 104 - 115
Publisher: ACADEMIC PRESS INC ELSEVIER SCIENCE
Publication Year: 2017
JRC N°: JRC107167
ISSN: 0273-2300
URI: http://www.sciencedirect.com/science/article/pii/S0273230017302696?via%3Dihub
http://publications.jrc.ec.europa.eu/repository/handle/JRC107167
DOI: 10.1016/j.yrtph.2017.08.019
Type: Articles in periodicals and books
Abstract: Physiologically based kinetic (PBK) models are used widely throughout a number of working sectors, including academia and industry, to provide insight into the dosimetry related to observed adverse health effects in humans and other species. Use of these models has increased over the last several decades, especially in conjunction with emerging alternative methods to animal testing, such as in vitro studies and data driven in silico quantitative-structure-activity-relationship (QSAR) predictions. Experimental information derived from these new approach methods can be used as input for model parameters and allows for increased confidence in models for chemicals that did not have in vivo data for model calibration. Despite significant advancements in good modelling practice (GMP) for model development and evaluation, there remains some reluctance among regulatory agencies to use such models during the risk assessment process. Here, the results of a survey disseminated to the modelling community are presented in order to inform the frequency of use and applications of PBK models in science and regulatory submission. Additionally, the survey was designed to identify a network of investigators involved in PBK modelling and knowledgeable of GMP so that they might be contacted in the future for peer review of PBK models, especially in regards to vetting the models to such a degree as to gain a greater acceptance for regulatory purposes.
JRC Directorate:Health, Consumers and Reference Materials

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.