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Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from a US Food and Drug Administration (FDA)‐approved reference product. The development and approval of biosimilars is critical to enhancing the availability of safe, effective, and affordabl...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2022
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10092043/ https://www.ncbi.nlm.nih.gov/pubmed/36178447 http://dx.doi.org/10.1002/cpt.2761 |