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Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union
The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing...
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| Publicado no: | MAbs |
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| Main Authors: | , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Taylor & Francis
2014
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4622966/ https://ncbi.nlm.nih.gov/pubmed/25517301 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4161/mabs.29848 |
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