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
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.
|Audience:||Scientists - Regulators - Industry - Researchers|
|User access:||Restricted access - Fee-based access|
|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)|
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