(168)在临床前安全性研究中减少动物试验的路线图.pdfVIP

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  • 2025-12-11 发布于山东
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(168)在临床前安全性研究中减少动物试验的路线图.pdf

RoadmaptoReducingAnimal

TestinginPreclinicalSafetyStudies

ExecutiveSummary

Thisroadmapoutlinesastrategic,stepwiseapproachforFDAtoreduceanimaltestinginpreclinicalsafety

studieswithscientificallyvalidatednewapproachmethodologies(NAMs),suchasorgan-on-a-chipsystems,

computationalmodeling,andadvancedinvitroassays.BypartneringwithfederalagencieslikeNIHand

VAthroughICCVAM,FDAcanacceleratethevalidationandadoptionofthesehuman-relevantmethods,

improvingpredictiveaccuracywhilereducinganimalus

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