Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review

This study explores the revolutionary potential of in-silico clinical trials (ISCTs) in medical device development, emphasizing the integration of computational modeling and simulation (CM&S), artificial intelligence (AI), and machine learning (ML). It evaluates regulatory advancements by the FD...

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Vydané v:	Therapeutic innovation & regulatory science
Hlavní autori:	De, Arindam, Lohani, Alka
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Switzerland 07.10.2025
Predmet:	USFDA EMA Computer modelling and simulation Medical device Artificial intelligence In-silico clinical trials PMDA
ISSN:	2168-4790, 2168-4804, 2168-4804
On-line prístup:	Získať plný text
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