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New EU focus on in vitro ADME and in silico modelling for chemical testing

European Union regulatory bodies are often on the forefront of encouraging new methods to reduce animal testing. In July 2015, a five-year, multi-faceted strategy was announced by the EURL ECVAM to improve human ADME prediction through in vitro methods and in silico modelling with further emphasis on human physiologically-based toxicokinetic (TK) evaluation.

At the core of the plan is the critical push to develop a broader range of in vitro methods that provides a more complete picture of ADME properties. As these assays are developed, they then must be standardised. Next is the creation of online portals that house and provide open access to in silico, in vitro, and in vivo data that can be used to create and expand physiologically based toxicokinetic (PBTK) models and modelling tools. The third step in this five-year goal may prove the most challenging: data generation and aggregation into open databases. This goal is clearly defined in the EURL ECVAM’s strategic outline document; however, the plan to stimulate organisations to freely share proprietary information is not yet laid out. Finally, the plan calls for more regulatory anchoring, with standardisation and regulation clearly defined. Once a standard is established for prediction and collection of human ADME/TK data, guidelines will be published to provide a clear direction towards the further replacement, reduction and refinement (3Rs) of animal experiments, and can be applied to current EU regulatory frameworks such as REACH, Cosmetic Products, Biocidal Products and Plant Protection Products Regulations.

Toxicokinetic Provisional Timeline

Contact us to learn more about in vitro ADME testing and physiologically based toxicokinetic and pharmacokinetic (PBTK/PK) modelling.