Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, NJ, USA.
Drug Metabolism & Pharmacokinetics, EMD Serono, Billerica, MA, USA.
Bioanalysis. 2020 Apr;12(7):431-443. doi: 10.4155/bio-2019-0300. Epub 2020 Apr 28.
To present the reader with different approaches used to compare immunogenicity methods when changes are needed during a clinical program. Five case studies are presented, in the first two case studies, the approach utilized a small sample size for the comparison. In the third case, all samples from a study were analyzed by both methods. In the fourth case, the intended use of noncomparable assays in an integrated summary drove design of experiments to establish the expected limits of pooling data. In the fifth case, a selectivity approach was used as an alternate to use of incurred samples. When data pooling across methods is needed, it is important to define the limits of comparability.
为了向读者展示在临床项目中需要进行改变时，用于比较免疫原性方法的不同方法。呈现了五个案例研究，在前两个案例研究中，比较采用了小样本量的方法。在第三个案例中，所有研究样本均通过两种方法进行分析。在第四个案例中，在综合总结中打算使用不可比的检测方法，推动了实验设计以确定数据合并的预期范围。在第五个案例中，采用选择性方法作为使用已发生样本的替代方法。当需要跨方法进行数据合并时，定义可比性的限制很重要。
