抗药抗体检测的验证实验问题.pptxVIP

1;2;3;Challenges in ADA analysis;5;Cut Point Determination (Shankar et al);Cut Point Determination (Zhang et al);Steps for CP determination;Analytical or Biological Outlier?;Sequential Outlier Elimination;Pre-existing Antibodies;Effect of normalized signals;Suitability of the Negative Control;Acceptance Ranges for Assay Controls;Sensitivity;Sensitivity – Issues (I);Sensitivity of confirmatory assay;Pre-study versus in-study cut point;Pre-study versus in-study cut point;Specificity;Selectivity;Drug Tolerance;