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New FDA Draft Guidance on Immunogenicity

A “Late Breaking” session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss the US Food and Drug Administration’s (FDA) 2013 draft guidance on Immunogenicity Assessment for Therapeutic Protein Products. The session was...

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Detalhes bibliográficos
Main Authors: Parenky, Ashwin, Myler, Heather, Amaravadi, Lakshmi, Bechtold-Peters, Karoline, Rosenberg, Amy, Kirshner, Susan, Quarmby, Valerie
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2014
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4012054/
https://ncbi.nlm.nih.gov/pubmed/24682766
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-014-9587-6
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