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EU pharmacovigilance regulatory requirements of anticancer biosimilar monoclonal antibodies

An increasing number of innovative oncology monoclonal antibodies (mAbs) have been introduced into the global market, and biosimilar versions have now also been approved in Europe. Being complex to develop and difficult to manufacture, the biosimilar is a drug similar but not identical in physicoche...

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Podrobná bibliografie
Vydáno v:Int J Clin Pharm
Hlavní autoři: Francescon, Sara, Fornasier, Giulia, Baldo, Paolo
Médium: Artigo
Jazyk:Inglês
Vydáno: Springer International Publishing 2018
Témata:
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC6132979/
https://ncbi.nlm.nih.gov/pubmed/30094558
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s11096-018-0709-6
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