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Changes in regulations for approval of therapeutics

As we enter the decade of the 2010s, regulatory agencies in the United States and the European Union are currently establishing a variety of new initiatives, guidances and guidelines that aim to facilitate the development and approval of therapeutics, including antibodies.

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Detalhes bibliográficos
Publicado no:MAbs
Autor principal: Reichert, Janice M.
Formato: Artigo
Idioma:Inglês
Publicado em: Taylor & Francis 2010
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7098651/
https://ncbi.nlm.nih.gov/pubmed/25225706
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4161/mabs.12369
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