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Demonstration of Equivalence of Generic Glatiramer Acetate and Copaxone(®)
The objective of the current work was to demonstrate the equivalence of Mylan’s glatiramer acetate (GA) to that of the reference product Copaxone(®) (COP) using the four criteria for active pharmaceutical ingredient sameness as established by the US Food and Drug Administration (FDA). The reaction s...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8740218/ https://www.ncbi.nlm.nih.gov/pubmed/35002702 http://dx.doi.org/10.3389/fphar.2021.760726 |