免疫原性分析

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我们通过使用阶梯式方法(筛选试验后进行验证试验)测量 ADA 水平来评估药物免疫原性及其对 PK 和 PD 的影响。

ADA Bioanalysis for Anti-HER2 Immunogenicity Assessment

ADA tested using screening assay, confirmatory assay and titer assay
ADA occurred in one animal after repeated IV dosing

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