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Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”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of innovative and generic drug products that contain nanomaterials, the U.S. Food and Drug Administration issued the draft guidance for industry titled: “Drug Products, Including Biological Products, that Contain Nanomaterials” in December 2017.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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Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: 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: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2019
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6470106/
https://ncbi.nlm.nih.gov/pubmed/30997588
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-019-0329-7
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