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New FDA Draft Guidance on Immunogenicity
A “Late Breaking” session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss the US Food and Drug Administration’s (FDA) 2013 draft guidance on Immunogenicity Assessment for Therapeutic Protein Products. The session was...
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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: |
Springer US
2014
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| 主題: | |
| オンライン･アクセス: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4012054/ https://ncbi.nlm.nih.gov/pubmed/24682766 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-014-9587-6 |
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