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Bioequivalence of Intravenous Alteplase from Two Different Manufacturing Processes in Healthy Male Volunteers: Results from a Two-Stage, Adaptive-Design Study

OBJECTIVE: Alteplase is a recombinant tissue plasminogen activator used for thrombolytic treatment in several indications and is currently approved in Europe under the brand name Actilyse(®). The current manufacturing process for alteplase was recently modified to meet increasing global demands. The...

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Detalles Bibliográficos
Autores principales:	Glund, Stephan, Hoefler, Josef, Lang, Benjamin, Cafiero, Stephen, Panova-Noeva, Marina, Place, Corina, Wolff, Michael
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2023
Materias:	Original Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10338556/ https://www.ncbi.nlm.nih.gov/pubmed/37248330 http://dx.doi.org/10.1007/s40262-023-01253-3

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