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Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example
The global development of a biosimilar product is a methodologically complex affair, lined with potential design pitfalls and operational missteps to be avoided. Without careful attention to experimental design and meticulous execution, a development programme may fail to demonstrate equivalence, as...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BMJ Publishing Group
2016
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4746581/ https://www.ncbi.nlm.nih.gov/pubmed/26870392 http://dx.doi.org/10.1136/rmdopen-2015-000154 |