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Statistical and Bioanalytical Considerations for Establishing a Depletion Criterion for Specificity Testing During Immunogenicity Assessment of a Biotherapeutic
Immunogenicity assessment of fully human monoclonal antibody-based biotherapeutics requires sensitive and specific ligand binding assays. One of the components of specificity is the depletion of signal by a relevant biotherapeutic that is commonly based on an arbitrary depletion criterion of inhibit...
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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
2013
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| 主題: | |
| オンライン･アクセス: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3787216/ https://ncbi.nlm.nih.gov/pubmed/23990502 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9523-1 |
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