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Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective

PURPOSE: This article describes preclinical development of cell-based medicinal products for European markets and discusses European regulatory mechanisms open to developers to aid successful product development. Cell-based medicinal products are diverse, including cells that are autologous or allog...

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Detalles Bibliográficos
Autores principales: McBlane, James W., Phul, Parvinder, Sharpe, Michaela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6156759/
https://www.ncbi.nlm.nih.gov/pubmed/29943208
http://dx.doi.org/10.1007/s11095-018-2437-y