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

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Title: Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review.
Authors: De A; Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, India., Lohani A; Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, India. alkalohani06@gmail.com.
Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2026 Jan; Vol. 60 (1), pp. 45-62. Date of Electronic Publication: 2025 Oct 07.
Publication Type: Journal Article; Systematic Review
Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22De+A%22">De A</searchLink>; Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, India.<br /><searchLink fieldCode="AU" term="%22Lohani+A%22">Lohani A</searchLink>; Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, India. alkalohani06@gmail.com.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer+International+Publishing%22">Springer International Publishing </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>101597411 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2168-4804 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2221684790%22">21684790 </searchLink><i>NLM ISO Abbreviation: </i>Ther Innov Regul Sci <i>Subsets: </i>MEDLINE
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        Value: 10.1007/s43441-025-00871-2
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      – Code: eng
        Text: English
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        StartPage: 45
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      – TitleFull: Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review.
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            NameFull: De A
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              Text: 2026 Jan
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              Y: 2026
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