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Governance-Bound Artificial Intelligence for Evidence-Linked Medicines Reliance Review: A Design Science Research Study

2026-08-25

Abstract excerpt

<title>Abstract</title> <p>Background Regulatory reliance enables national regulatory authorities to give significant weight to prior scientific work by trusted authorities while retaining accountability for local decisions. However, reliance review remains document-intensive and cognitively demanding: assessors must interpret Common Technical Document (CTD) submissions, verify product sameness, identify discrep...

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Literature Corpus work
b001bafe-b639-5d4e-a0f5-dd13d300616d
DOI
10.21203/rs.3.rs-10090979/v1
Open publication

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