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Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars

Biologics such as monoclonal antibodies are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions of such biopharmaceutical products (also known as biosimilars) and their clinical use once patent protection...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: Berkowitz, Steven A., Engen, John R., Mazzeo, Jeffrey R., Jones, Graham B.
Format: Artigo
Sprache:Inglês
Veröffentlicht: 2012
Schlagworte:
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC3714370/
https://ncbi.nlm.nih.gov/pubmed/22743980
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1038/nrd3746
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