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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...
| Autores principales: | , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Public Library of Science
2018
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| 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 |