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From preclinical promise to regulatory reality: translation of small rodent acute injury therapies to human approval and safety outcomes: A systematic review

Timothy R. Entwistle et al.
PLOS · Papers · License: CC BY 4.0
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clinical-trialstraumatic-brain-injury
Background: Preclinical animal studies are considered essential for therapeutic development, yet translation to human benefit remains poor. The commonly cited translation rate of approximately 20% conflates trial entry with regulatory approval and may substantially overestimate the predictive validi
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