PBTK modelling platforms and parameter estimation tools to enable animal-free risk assessment: Recommendations from a joint EPAA – EURL ECVAM ADME workshop

Knowledge Source Identification
Knowledge source name	PBTK modelling platforms and parameter estimation tools to enable animal-free risk assessment: Recommendations from a joint EPAA – EURL ECVAM ADME workshop
Owner/Developer	Regulatory Toxicology and Pharmacology
Country	Netherlands
URL	http://www.sciencedirect.com/science/article/pii/S0273230013002092
Description	Information on toxicokinetics is critical for animal-free human risk assessment. Human external exposure must be translated into human tissue doses and compared with in vitro actual cell exposure associated to effects (in vitro–in vivo comparison). Data on absorption, distribution, metabolism and excretion in humans (ADME) could be generated using in vitro and QSAR tools. Physiologically-based toxicokinetic (PBTK) computer modelling could serve to integrate disparate in vitro and in silico findings. [...] This paper is based on a joint EPAA – EURL ECVAM expert meeting. It provides a state-of-the-art overview of the availability of PBTK platforms as well as the in vitro and in silico methods to parameterise basic (Tier 1) PBTK models. Five high-priority issues are presented that provide the prerequisites for wider use of non-animal based PBTK modelling for animal-free chemical risk assessment.
Knowledge Source Category
Category	Publication
Sub categories	Report, Review / Research article
Knowledge Dissemination and Sharing
Dissemination channel	Website
Targeted audience (specified/objective analysis)	Scientists, Regulators, Industry, Researchers
Users access	Restricted access, Fee-based access
Knowledge Characterization
3Rs relevance	Replacement, Reduction
Purpose	Toxicological and safety evaluation, Method development, Validation, Documentation and information
Technology/Tools	Alternative test methods (in vitro), Non-testing methods (in silico)