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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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Autors principals: García-Arieta, Alfredo, Gordon, John
Format: Artigo
Idioma:Inglês
Publicat: Springer US 2012
Matèries:
Accés en línia: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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