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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...
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| Publicado no: | Am J Ther |
|---|---|
| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
American Journal of Therapeutics
2016
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5102275/ https://ncbi.nlm.nih.gov/pubmed/26766293 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1097/MJT.0000000000000391 |
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