Synthesizing regulatory guidance for demonstrating preclinical efficacy and translating promising cell therapies to early phase clinical trials: a scoping review

Abstract Background Regulatory applications for cell therapy face more objections compared to conventional small molecule or biological drugs, leading to delays in market approval and clinical adoption. Increased regulatory objections frequently relate to issues regarding preclinical evidence, such...

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Autori principali:	Matthew S. Jeffers, Cheng En Xi, Raj Bapuji, Hannah Wotherspoon, Jonathan Kimmelman, Patrick Bedford, Daniel I. McIsaac, Manoj M. Lalu, Dean A. Fergusson
Natura:	Artigo
Lingua:	Inglês
Pubblicazione:	BMC 2024-10-01
Serie:	BMC Medicine
Soggetti:	Preclinical Animal Cell therapy Stem cell Clinical trials International Council for Harmonisation
Accesso online:	https://doi.org/10.1186/s12916-024-03690-8
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