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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Bibliografiske detaljer
Udgivet i: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
Format: Artigo
Sprog:Inglês
Udgivet: Taylor & Francis 2016
Fag:
Brief Report
Online adgang: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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