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Bioequivalence Requirements in the European Union: Critical Discussion

The aim of the present paper is to summarize the revised European Union (EU) Guideline on the Investigation of Bioequivalence and to discuss critically with respect to previous European requirements and present US Food and Drug Administration guidelines its more relevant novelties such as the follow...

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Detalles Bibliográficos
Autores principales: García-Arieta, Alfredo, Gordon, John
Formato: Artigo
Lenguaje:Inglês
Publicado: Springer US 2012
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Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC3475855/
https://ncbi.nlm.nih.gov/pubmed/22826032
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-012-9382-1
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