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Evaluation of analytical similarity between trastuzumab biosimilar CT-P6 and reference product using statistical analyses

The evaluation of analytical similarity has been a challenging issue for the biosimilar industry because the number of lots for reference and biosimilar products available at the time of development are limited, whilst measurable quality attributes of target molecule are numerous, which can lead to...

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Detalles Bibliográficos
Autores principales:	Lee, Jihun, Kang, Hyun Ah, Bae, Jin Soo, Kim, Kyu Dae, Lee, Kyoung Hoon, Lim, Ki Jung, Choo, Min Joo, Chang, Shin Jae
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Taylor & Francis 2018
Materias:	Report
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5973688/ https://www.ncbi.nlm.nih.gov/pubmed/29482416 http://dx.doi.org/10.1080/19420862.2018.1440170

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