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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Bibliografische gegevens
Gepubliceerd in:MAbs
Hoofdauteurs: Vana, Alicia M., Freyman, Amy W., Reich, Steven D., Yin, Donghua, Li, Ruifeng, Anderson, Scott, Jacobs, Ira A., Zacharchuk, Charles M., Ewesuedo, Reginald
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: Taylor & Francis 2016
Onderwerpen:
Brief Report
Online toegang: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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