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经验证的测定

Q2 Solutions 在生物分析服务方面拥有 20 多年的经验,并开发了稳健的分析方法,为药物发现和研发的所有阶段提供支持。我们开发的经验证测定适用于多种用途,包括 ADME 筛选/ADME 检测、发现和开发代谢物鉴定、药物代谢和药代动力学、免疫原性检测、生物标志物分析和表征,以及生物类似药检测。方法包括 LC/MS 生物分析、LC/MS/MS 分析、混合 LC/MS 测定、免疫测定和基于 MS 的生物标志物测定。验证前,每项测定都要经历正式的资格预审流程,其中 Q2 Solutions 科学家将审查初步数据,并评估支持验证所需的修改。

 

以下链接提供了 Q2 Solutions 为支持临床试验(包括 COVID-19 试验)申请而开发的经验证的生物分析方法列表。除已列出的测定方法外,Q2 Solutions 还开发用于应对特定挑战定制化的方法。

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