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Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar
A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For...
Autores principales: | Kim, Seokkyun, Song, Jinsu, Park, Seungkyu, Ham, Sunyoung, Paek, Kyungyeol, Kang, Minjung, Chae, Yunjung, Seo, Heewon, Kim, Hyung-Chan, Flores, Michael |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5419076/ https://www.ncbi.nlm.nih.gov/pubmed/28296619 http://dx.doi.org/10.1080/19420862.2017.1305530 |
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