PubMed

Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review.

PMID: 34161248 · 2021-10-05

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ЖурналIEEE journal of biomedical and health informatics

Год2021-10-05

PMID34161248

Аннотация

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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