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...

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Dades bibliogràfiques
Publicat a:MAbs
Autors principals: Vana, Alicia M., Freyman, Amy W., Reich, Steven D., Yin, Donghua, Li, Ruifeng, Anderson, Scott, Jacobs, Ira A., Zacharchuk, Charles M., Ewesuedo, Reginald
Format: Artigo
Idioma:Inglês
Publicat: Taylor & Francis 2016
Matèries:
Brief Report
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC4968111/
https://ncbi.nlm.nih.gov/pubmed/27050730
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/19420862.2016.1171431
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