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Biopharmaceutics Classification System-Based Biowaivers for Generic Oncology Drug Products: Case Studies
Establishing bioequivalence (BE) of drugs indicated to treat cancer poses special challenges. For ethical reasons, often, the studies need to be conducted in cancer patients rather than in healthy volunteers, especially when the drug is cytotoxic. The Biopharmaceutics Classification System (BCS) int...
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| Publicado no: | AAPS PharmSciTech |
|---|---|
| Main Authors: | , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer US
2014
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4309807/ https://ncbi.nlm.nih.gov/pubmed/25245330 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-014-0195-7 |
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