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An Efficient Development Paradigm for Biosimilars
The current development paradigm for biosimilars required by regulators in highly regulated jurisdictions is derived from the development of novel drugs and is unnecessarily burdensome and inefficient. It requires the accumulation of data from analytical, nonclinical (including in vivo studies in so...
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| Publicado no: | BioDrugs |
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| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer International Publishing
2019
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6875142/ https://ncbi.nlm.nih.gov/pubmed/31388969 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-019-00371-4 |
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