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Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study
The case study described in this paper was developed for the purpose of training for a better understanding of principles relating especially to a comprehensive evaluation of multiple quality attributes as outlined in the WHO guidelines on evaluation of similar biotherapeutic products. It is also to...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Academic Press
2019
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6863428/ https://www.ncbi.nlm.nih.gov/pubmed/31668854 http://dx.doi.org/10.1016/j.biologicals.2019.10.006 |