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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Detalhes bibliográficos
Publicado no:MAbs
Main Authors: Vana, Alicia M., Freyman, Amy W., Reich, Steven D., Yin, Donghua, Li, Ruifeng, Anderson, Scott, Jacobs, Ira A., Zacharchuk, Charles M., Ewesuedo, Reginald
Formato: Artigo
Idioma:Inglês
Publicado em: Taylor & Francis 2016
Assuntos:
Brief Report
Acesso em linha: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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