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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Autores principales: Carolina Iglesias-Lopez, Antonia Agustí, Antoni Vallano, Merce Obach
Formato: article
Lenguaje:EN
Publicado: Elsevier 2021
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Acceso en línea:https://doaj.org/article/43c715acca8f4480a4c1e57dcd181861
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