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Biosimilars and the extrapolation of indications for inflammatory conditions
Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly studied in a comparative clinical trial with the biosimilar. Extrapolation is a scientific rationale that bridges all the data collected (ie, totality of the evidence) from one indicat...
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| Publicado no: | Biologics |
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| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Dove Medical Press
2017
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5322938/ https://ncbi.nlm.nih.gov/pubmed/28255229 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2147/BTT.S124476 |
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