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Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance
The principles of comparability assessments have been accepted globally as offering sensitive and reliable tools with which to evaluate potential changes to biologics that may arise either through processing changes or through the creation of a copy (biosimilar) by a different sponsor. The comparabi...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2021
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295099/ https://www.ncbi.nlm.nih.gov/pubmed/34143406 http://dx.doi.org/10.1007/s40259-021-00488-5 |