Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union

The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing...

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Detalles Bibliográficos
Autores principales: van Aerts, Leon AGJM, De Smet, Karen, Reichmann, Gabriele, van der Laan, Jan Willem, Schneider, Christian K
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2014
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4622966/
https://www.ncbi.nlm.nih.gov/pubmed/25517301
http://dx.doi.org/10.4161/mabs.29848

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4622966/
https://www.ncbi.nlm.nih.gov/pubmed/25517301
http://dx.doi.org/10.4161/mabs.29848

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