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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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| Auteurs principaux: | , |
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| Format: | Artigo |
| Langue: | Inglês |
| Publié: |
Springer US
2012
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| Sujets: | |
| Accès en ligne: | 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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