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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...
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| 主要な著者: | , , |
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| フォーマット: | Artigo |
| 言語: | Inglês |
| 出版事項: |
2012
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| 主題: | |
| オンライン･アクセス: | 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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