Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review.
PMID: 34161248 ·
Marco Viceconti, Luca Emili, Payman Afshari, Eulalie Courcelles, Cristina Curreli, Nele Famaey, Liesbet Geris, Marc Horner, Maria Cristina Jori, Alexander Kulesza, Axel Loewe, Michael Neidlin, Markus Reiterer, Cecile F Rousseau, Giulia Russo, Simon J Sonntag, Emmanuelle M Voisin, Francesco Pappalardo
Abstract
The term "In Silico Trial" indicates the use of computer modelling and simulation to evaluate the safety and efficacy of a medical product, whether a drug, a medical device, a diagnostic product or an advanced therapy medicinal product. Predictive models are positioned as new methodologies for the development and the regulatory evaluation of medical products. New methodologies are qualified by regulators such as FDA and EMA through formal processes, where a first step is the definition of the Co
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