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Current landscape of clinical development and approval of advanced therapies

Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. The uncertainty about the product's benefit-risk balance at the time of approval, the limitations of nonclinical development, and the complex quality aspects of...

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Detalles Bibliográficos
Autores principales: Iglesias-Lopez, Carolina, Agustí, Antonia, Vallano, Antoni, Obach, Merce
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Gene & Cell Therapy 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8626628/
https://www.ncbi.nlm.nih.gov/pubmed/34901306
http://dx.doi.org/10.1016/j.omtm.2021.11.003