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Regulatory considerations in oncologic biosimilar drug development

Biosimilar monoclonal antibodies are being developed globally for patients with different types of solid tumors and hematologic malignancies. Applications for proposed biosimilar monoclonal antibodies are being submitted to the regulatory authorities around the world and may increase patient access...

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Bibliografiske detaljer
Udgivet i:MAbs
Main Authors: Macdonald, Judith C, Hartman, Helen, Jacobs, Ira A
Format: Artigo
Sprog:Inglês
Udgivet: Taylor & Francis 2015
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4622730/
https://ncbi.nlm.nih.gov/pubmed/25961747
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/19420862.2015.1040973
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