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Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy
The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Bi...
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| Main Authors: | , , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2011
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3228645/ https://ncbi.nlm.nih.gov/pubmed/21775984 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1038/clpt.2011.109 |
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