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一个数据驱动的逐步方法交叉验证临床抗药抗体 (ADA) 试验

Sally Ye1, Yan Mao2, Kelly Coble2

  • 1Bioanalysis (Department of Drug Metabolism & Pharmacokinetics), Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, Connecticut, 06877, USA. sally.ye@boehringer-ingelheim.com.

The AAPS journal
|February 10, 2026
PubMed
概括

实验室之间对抗药物抗体 (ADA) 测定进行交叉验证是很困难的,因为实践不一致. 本文详细介绍了一种数据驱动的逐步方法,以协调ADA试验交叉验证以获得可靠的结果.

关键词:
对抗药物抗体的抗体.可比性 可比性交叉实验室对比 实验室对比通过交叉验证验证.免疫性 免疫性 免疫性方法验证方法验证

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