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An Efficient Development Paradigm for Biosimilars

The current development paradigm for biosimilars required by regulators in highly regulated jurisdictions is derived from the development of novel drugs and is unnecessarily burdensome and inefficient. It requires the accumulation of data from analytical, nonclinical (including in vivo studies in so...

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Detalles Bibliográficos
Autores principales:	Webster, Christopher J., Wong, Anny C., Woollett, Gillian R.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2019
Materias:	Current Opinion
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875142/ https://www.ncbi.nlm.nih.gov/pubmed/31388969 http://dx.doi.org/10.1007/s40259-019-00371-4

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