Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues

Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues

ABSTRACT With the recent and evolving regulatory frameworks regarding the usage of Artificial Intelligence (AI) in both drug and medical device development, the differentiation between data derived from observed (‘true’ or ‘real’) sources and artificial data obtained using process‐driven and/or (dat...

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Bibliographic Details
Main Authors: Giuseppe Pasculli, Marco Virgolin, Puja Myles, Anna Vidovszky, Charles Fisher, Elisabetta Biasin, Miranda Mourby, Francesco Pappalardo, Saverio D'Amico, Mario Torchia, Alexander Chebykin, Vincenzo Carbone, Luca Emili, Daniel Roeshammar
Format: Article
Language:English
Published: Wiley 2025-05-01
Series:CPT: Pharmacometrics & Systems Pharmacology
Subjects:
drug development
external control arms
generative AI
medical devices
real‐world data
regulatory framework
Online Access:https://doi.org/10.1002/psp4.70021
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https://doi.org/10.1002/psp4.70021

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