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An evaluation roadmap for critical quality attributes from tier 1 in analytical similarity assessment

Analytical similarity assessment of critical quality attributes (CQAs) serves as a foundation for the development of biosimilar products and facilitates an abbreviated subsequent clinical evaluation. In this study, we establish a statistical evaluation roadmap with statistical approaches for some se...

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Detalles Bibliográficos
Autores principales: Wu, Kejian, Pan, Haitao, Li, Chen, Zhao, Qingbo, Wang, Ling, Xia, Jielai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6283468/
https://www.ncbi.nlm.nih.gov/pubmed/30521581
http://dx.doi.org/10.1371/journal.pone.0208354

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