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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Bibliografiska uppgifter
I publikationen:MAbs
Huvudupphovsmän: Vana, Alicia M., Freyman, Amy W., Reich, Steven D., Yin, Donghua, Li, Ruifeng, Anderson, Scott, Jacobs, Ira A., Zacharchuk, Charles M., Ewesuedo, Reginald
Materialtyp: Artigo
Språk:Inglês
Publicerad: Taylor & Francis 2016
Ämnen:
Brief Report
Länkar: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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