The need for a framework to justify that a model has sufficient credibility to be used as a basis for internal or external (typically regulatory) decision-making is a primary concern when using modelling and simulation (M&S) in healthcare. This chapter reviews published standards on verification, validation, and uncertainty quantification (VVUQ) as well as regulatory guidance that can be used to establish model credibility in this context, providing a potential starting point for a globally harmonised model credibility framework.

Courcelles E., Horner M., Afshari P., Kulesza A., Curreli C., Vaghi C., et al. (2024). Model Credibility. Berlin : Springer Cham, 2024 [10.1007/978-3-031-48284-7_4].

Model Credibility

Viceconti M.;
2024

Abstract

The need for a framework to justify that a model has sufficient credibility to be used as a basis for internal or external (typically regulatory) decision-making is a primary concern when using modelling and simulation (M&S) in healthcare. This chapter reviews published standards on verification, validation, and uncertainty quantification (VVUQ) as well as regulatory guidance that can be used to establish model credibility in this context, providing a potential starting point for a globally harmonised model credibility framework.
2024
Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products.
43
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Courcelles E., Horner M., Afshari P., Kulesza A., Curreli C., Vaghi C., et al. (2024). Model Credibility. Berlin : Springer Cham, 2024 [10.1007/978-3-031-48284-7_4].
Courcelles E.; Horner M.; Afshari P.; Kulesza A.; Curreli C.; Vaghi C.; Morales-Orcajo E.; Pappalardo F.; Maquer G.; Russo G.; Geris L.; Viceconti M.;...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/971677
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