Biosimilars: Key regulatory considerations and similarity assessment tools

A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already licensed biologic product (referred to as the reference product) notwithstanding minor differences in clinically inactive components and for which t...

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Bibliografiske detaljer
Udgivet i:Biotechnol Bioeng
Main Authors: Kirchhoff, Carol F., Wang, Xiao‐Zhuo Michelle, Conlon, Hugh D., Anderson, Scott, Ryan, Anne M., Bose, Arindam
Format: Artigo
Sprog:Inglês
Udgivet: John Wiley and Sons Inc. 2017
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Reviews
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC5698755/
https://ncbi.nlm.nih.gov/pubmed/28842986
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/bit.26438
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