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The Role of PD Biomarkers in Biosimilar Development – To Get the Right Answer One Must First Ask the Right Question
The potential for pharmacodynamic (PD) biomarkers to improve the efficiency of biosimilar product development and regulatory approval formed the premise for the virtual workshop Pharmacodynamic Biomarkers for Biosimilar Development and Approval hosted by the US Food and Drug Administration (FDA) and...
| 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/PMC10092046/ https://www.ncbi.nlm.nih.gov/pubmed/36148870 http://dx.doi.org/10.1002/cpt.2753 |