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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...

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Detalles Bibliográficos
Autores principales: Woollett, Gillian R., Park, Joseph P., Han, Jihyun, Jung, Byoungin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
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