New paper proposes a Credibility Assessment Plan for an in silico model for dose-response prediction

The paper is titled "A Credibility Assessment Plan for an in silico model that predicts

the dose–response relationship of new Tuberculosis treatments" (authored by Cristina Curreli and Marco Viceconti from University of Bologna and Valentina Di Salvatore, Giulia Russo and Francesco Pappalardo from University of Catania) and has been recently published in the Annals of Biomedical Engineering.

The work, which a previous and shorter version has been presented at the VPH 2022 Conference poster session, explains how the agent-based Universal Immune System Simulator was used to develop an In Silico Trials environment that can predict the dose–response of new therapeutic vaccines against pulmonary tuberculosis, supporting the optimal design of clinical trials.

But before such in silico methodology can be used in the evaluation of new treatments, it is mandatory to assess the credibility of this predictive model. This study presents a risk-informed credibility assessment plan inspired by the ASME V&V 40-2018 technical standard.

The work provides an example of the first steps required for the regulatory evaluation of an agent-based model used in the context of drug development.

The full paper is available in Open Access at this link.

In the picture, Dr Cristina Curreli presenting the preliminary results of the above mentioned work during the VPH 2022 Conference in Porto, Portugal.

The VPH Conference is one of the most important conferences on in silico medicine, Strituvad was among the EU Projects that had visibility at the VPH booth.