Organ-on-Chip Models in Regulatory Submissions: A Perspective on Evidentiary Weight
DOI:
https://doi.org/10.5281/zenodo.22649331Keywords:
Organ-on-Chip Models in Regulatory Submissions;, Translational medicine; Evidence synthesis;, Clinical implementation; Health services researchAbstract
Organ-on-Chip Models in Regulatory Submissions is an area of active development in translational medicine, with evidence that
has accumulated unevenly across its component questions. We review the current evidence base for organ-on-chip models in
regulatory submissions, spanning analytical, clinical, implementation, governance, and economic dimensions, focusing on where
practice has converged and where it continues to vary, and set out the practical considerations relevant to a service considering
its adoption. We conclude that selective, context-specific use is best supported by the evidence currently available, rather than
uniform adoption or avoidance
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