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This review article comprehensively analyzes current regulatory frameworks and guidance for AI/ML in pharmaceutical Good Manufacturing Practice (GMP) settings, identifies
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Considerations for the Use of Artificial Intelligence
This guidance provides recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) to produce information or data intended to support regulatory...
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Use of Artificial Intelligence (AI) in the medicinal product lifecycle
This paper reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicines'' lifecycle, from drug discovery to the post
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In 2024 and early 2025, major regulatory bodies including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the International Council for
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