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...

Descripción completa

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:
Research Article
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

Internet

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

Ejemplares similares