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Professional bodies have also responded: in July 2025 the International Society for Pharmaceutical Engineering (ISPE) issued a new GAMP Guide on Artificial Intelligence , providing a holistic framework for AI in GxP-regulated environments and emphasizing patient safety, product quality, and data integrity ( [23] ) ( [24] )

[DOI] [PMC free article] [PubMed] [Google Scholar] 35.ONeil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, et al

Hypoglycemia is the variable that derails protocols most often

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