Evaluating imbalances of adverse events during biosimilar development

Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clin...

Descripción completa

Detalles Bibliográficos
Autores principales: Vana, Alicia M., Freyman, Amy W., Reich, Steven D., Yin, Donghua, Li, Ruifeng, Anderson, Scott, Jacobs, Ira A., Zacharchuk, Charles M., Ewesuedo, Reginald
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2016
Materias:
Brief Report
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968111/
https://www.ncbi.nlm.nih.gov/pubmed/27050730
http://dx.doi.org/10.1080/19420862.2016.1171431

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968111/
https://www.ncbi.nlm.nih.gov/pubmed/27050730
http://dx.doi.org/10.1080/19420862.2016.1171431

Ejemplares similares