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A Step-wise Approach for Transfer of Immunogenicity Assays during Clinical Drug Development
We designed a three-step statistical approach to transfer bioanalytical assays (ELISA and Biacore) which evaluates the (1) average equivalence between the two labs (2) concordance in individual sample results between the two labs, and (3) long-term stability of assay performance. Each experimental d...
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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
2009
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| 主題: | |
| オンライン･アクセス: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2758123/ https://ncbi.nlm.nih.gov/pubmed/19626442 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-009-9130-3 |
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