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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...

Полное описание

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Библиографические подробности
Опубликовано в: :J Clin Transl Sci
Главные авторы: Vandivort, Tyler C., Horton, David B., Johnson, Steven B.
Формат: Artigo
Язык:Inglês
Опубликовано: Cambridge University Press 2020
Предметы:
Online-ссылка: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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