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Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs

The last three decades have seen the biotherapeutic drug market evolve from promising concept to market dominance in a range of clinical indications. This growth has been spurred by the success of established drug classes like monoclonal antibodies, but also by the introduction of biosimilars, and m...

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Shranjeno v:
Bibliografske podrobnosti
izdano v:J Clin Transl Sci
Main Authors: Vandivort, Tyler C., Horton, David B., Johnson, Steven B.
Format: Artigo
Jezik:Inglês
Izdano: Cambridge University Press 2020
Teme:
Online dostop:https://ncbi.nlm.nih.gov/pmc/articles/PMC8057416/
https://ncbi.nlm.nih.gov/pubmed/33948231
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1017/cts.2020.493
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