Handbook - COT FSA PBPK for Regulators Workshop 2021

Preface and workshop objectives - Handbook 2021 Workshop

Last updated: 11 April 2024

The UK FSA and the COT would like to thank you for your attendance and contributions at this workshop.

The future of food safety assessment in the UK depends on our adaptability, flexibility and revolutionary principles in order to respond to the accelerating developments in science and technology. The Tox21 approach4 is an example of one of the major recent scientific advancements in the development of alternative toxicity testing and computer modelling strategies for the evaluation of hazard and exposure. (Toxicology in the 21st Century (Tox21) is a US federal research collaboration testing thousands of environmental chemicals using non-animal methods for potential health effects. Further information is available on the Tox21 website. See also the US EPA’s website for adopting new approach methodologies). A key aspect of this strategy is linking active concentrations in vitro to likely concentrations in vivo, for which physiologically based pharmacokinetic (PBPK) modelling is essential.

The application of such alternative strategies to health risk assessment in a regulatory context requires effective collaborations between scientists including chemists, toxicologists, informaticians, computational biologists, risk assessors, and policy makers. As such, this workshop has invited speakers with varied backgrounds including; academia, industry and regulatory agencies whose collective experience is diverse and multi-disciplinary.

This workshop on PBPK modelling techniques thus provides a platform from which to address the following objectives;

  • To gain a better understanding of what PBPK models are and their application to risk assessment in regulatory fields;
  • Advantages and limitations of PBPK modelling;
  • What must be achieved to overcome limitations for integration into current health risk assessment practices;
  • An interactive session involving a model run-through and;
  •  Any lessons learnt from authoritative bodies or industry.

We plan to publish a summary of proceedings from this workshop (either as a COT statement output and/or in the literature).