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Demonstration of Biological and Immunological Equivalence of a Generic Glatiramer Acetate
BACKGROUND: In April 2015, the US Food and Drug Administration approved the first generic glatiramer acetate, Glatopa® (M356), as fully substitutable for Copaxone® 20 mg/mL for relapsing forms of multiple sclerosis (MS). This approval was accomplished through an Abbreviated New Drug Applica-tion tha...
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| Vydáno v: | CNS Neurol Disord Drug Targets |
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| Hlavní autoři: | , , , , , , , , , |
| Médium: | Artigo |
| Jazyk: | Inglês |
| Vydáno: |
Bentham Science Publishers
2017
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| Témata: | |
| On-line přístup: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5684786/ https://ncbi.nlm.nih.gov/pubmed/28240190 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2174/1871527316666170223162747 |
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