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实现加速到人类第一:MSD对平台方法验证战略的学习

Xiaoqing Hua1, Jorge Quiroz2, Joop Waterval1

  • 1Analytical Research & Development, MSD, Rahway, NJ, USA.

mAbs
|February 18, 2025
PubMed
概括

MSD开发了一个平台分析方法验证方法来加速早期药物开发. 这一策略将验证时间从4个月缩短到1-2个月,使得首次在人身上试验的速度更快.

关键词:
平台验证平台的验证加速到FIH的速度.进行统计分析,统计分析.

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Data Validation01:15

Data Validation

Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
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