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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...
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| Publicado no: | BioDrugs |
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| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer International Publishing
2021
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC8295099/ https://ncbi.nlm.nih.gov/pubmed/34143406 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-021-00488-5 |
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