The widespread use and acceptance of PBPK modelling has been advocated for many years, as this technique offers a more scientific and quantitative approach to chemical risk assessment, as well as offering the opportunity of a marked reduction in the use of animals in experimentation. However, the perceived complexity, data demands and the lack of expertise in evaluating PBPK models, particularly amongst toxicologists, have limited the take-up of this powerful approach. This project will address these issues and should facilitate the dialogue between industry and regulatory bodies as well as contribute the development of Good Modelling Practice. HSL has developed a software package which is currently at the’proof of concept’ stage. The package comprises a PBPK model equation generator (MEG) and a PBPK database of parameters. This project will aim to integrate the MEG with the database, improving the efficiency of the model development process. The MEG will also be improved and expanded, extending the scope of the modelling package. This project will further develop the capability to rapidly generate physiologically-based pharmacokinetic (PBPK) models. HSL will make available the outcome of the research to the scientific, regulatory and industrial communities for evaluation and use.
Final report and publications expected for 2007.