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Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”

To guide developers of innovative and generic drug products that contain nanomaterials, the U.S. Food and Drug Administration issued the draft guidance for industry titled: “Drug Products, Including Biological Products, that Contain Nanomaterials” in December 2017. During the AAPS Guidance Forum on...

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Detalles Bibliográficos
Autores principales: de Vlieger, Jon S. B., Crommelin, Daan J. A., Tyner, Katherine, Drummond, Daryl C., Jiang, Wenlei, McNeil, Scott E., Neervannan, Sesha, Crist, Rachael M., Shah, Vinod P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6470106/
https://www.ncbi.nlm.nih.gov/pubmed/30997588
http://dx.doi.org/10.1208/s12248-019-0329-7