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Opportunities and challenges for applying model‐informed drug development approaches to gene therapies

As part of the US Food and Drug Administration (FDA)’s Prescription Drug User Fee Act (PDUFA) VI commitments, the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are conducting a model‐informed drug development (MIDD) pilot program. Sponsor(s) w...

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Detalles Bibliográficos
Autores principales:	Belov, Artur, Schultz, Kimberly, Forshee, Richard, Tegenge, Million A.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2021
Materias:	Reviews
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099439/ https://www.ncbi.nlm.nih.gov/pubmed/33608998 http://dx.doi.org/10.1002/psp4.12597

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