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Statistical Primer on Biosimilar Clinical Development
A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the or...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
American Journal of Therapeutics
2016
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5102275/ https://www.ncbi.nlm.nih.gov/pubmed/26766293 http://dx.doi.org/10.1097/MJT.0000000000000391 |