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Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices
The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still considerable controversy on the scientific basis for extrapolation of indications for biosimilars, which has be...
Tallennettuna:
| Julkaisussa: | BioDrugs |
|---|---|
| Päätekijät: | , |
| Aineistotyyppi: | Artigo |
| Kieli: | Inglês |
| Julkaistu: |
Springer International Publishing
2016
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| Aiheet: | |
| Linkit: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4746210/ https://ncbi.nlm.nih.gov/pubmed/26758077 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-015-0154-1 |
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