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ICH M10 生物分析方法验证指南-1 年后

Faye Vazvaei-Smith1, Enaksha Wickremsinhe2, Eric Woolf3

  • 1Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics, Merck & Co., Inc., West Point, Pennsylvania, USA.

The AAPS journal
|September 12, 2024
PubMed
概括

国际协调理事会 (ICH) M10关于生物分析方法验证的指南提出了实施挑战. 最近的一次会议强调了生物分析界和监管视角的关键讨论点.

关键词:
国际协调理事会指南M10 国际协调理事会指南M10生物分析方法验证组合药物稳定性 药物稳定性进行比较生物利用性研究.进行交叉验证.内源分析物的生物分析.平行主义平行主义.研究样本分析研究样本分析

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相关概念视频

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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