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Establishment of reference standards in biosimilar studies

When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus,...

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Detalhes bibliográficos
Main Authors: Zhang, Aijing, Tzeng, Jung-Ying, Chow, Shein-Chung
Formato: Artigo
Idioma:Inglês
Publicado em: 2013
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3984577/
https://ncbi.nlm.nih.gov/pubmed/24734164
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