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...

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Detalles Bibliográficos
Autores principales: Lipsky, Peter, Vallano, Patrick T., Smith, Jeffrey, Owens, Walter, Snider, Daniel, Bandaru, Viswanath, Sun, Yunfu, Wallingford, Ross, Duncan, Joseph, Lewis, Joshua, Southall, Jason, Ansari, Azeem, Li, Hong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Pharmacology
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

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