Quality by Design–Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira®

Quality by design (QbD) is an efficient but challenging approach for the development of biosimilar due to the complex relationship among process, quality, and efficacy. Here, the analytical similarity of adalimumab biosimilar HLX03 to Humira® was successfully established following a QbD quality stud...

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Detalles Bibliográficos
Autores principales: Zhang, Erhui, Xie, Liqi, Qin, Peilan, Lu, Lihong, Xu, Yanpeng, Gao, Wenyuan, Wang, Linlin, Xie, Michael Hongwei, Jiang, Weidong, Liu, Scott
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Protocols in Pharmaceutical Sciences
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7210234/
https://www.ncbi.nlm.nih.gov/pubmed/32385732
http://dx.doi.org/10.1208/s12248-020-00454-z

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7210234/
https://www.ncbi.nlm.nih.gov/pubmed/32385732
http://dx.doi.org/10.1208/s12248-020-00454-z

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