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Statistical considerations in biosimilar assessment using biosimilarity index

When an innovative biologic product goes off patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. Unlike small molecule drug products, biosimilars are not exact copies of their brand-name counterpart, and they are usually ver...

Täydet tiedot

Tallennettuna:
Bibliografiset tiedot
Päätekijät: Zhang, Aijing, Tzeng, Jung-Ying, Chow, Shein-Chung
Aineistotyyppi: Artigo
Kieli:Inglês
Julkaistu: 2012
Aiheet:
Linkit:https://ncbi.nlm.nih.gov/pmc/articles/PMC3967514/
https://ncbi.nlm.nih.gov/pubmed/24683298
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4172/jbb.1000160
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