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Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

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The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.

Abstract

The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement with RIVM. The results obtained with a newly coded PBPK model for TCDD in the rat in Berkeley Madonna revealed good reproducibility of previously reported graphs. A selection of key figures could be adequately simulated with the recoded models. Altogether it can be concluded that the PBPK codes for TCDD in rat and human can be adequately run in Berkeley Madonna