European Bioanalysis Forum recommendation on embracing a context-of-use-driven scientific validation for chromatographic assays in the light of ICH M10
欧洲生物分析论坛建议根据ICH M10指南,采用基于使用情境的科学验证方法对色谱分析进行验证。
期刊:Bioanalysis
影响因子:1.8
doi:10.1080/17576180.2025.2555774
Timmerman, Philip; McDougall, Stuart; Adcock, Neil; Arfvidsson, Cecilia; Barfield, Matthew; Blech, Stefan; Cowan, Kyra J; Ferrari, Luca; Greco, Alessandro; Golob, Michaela; Goodwin, Lee; Hughes, Richard; Ivanova, Tsvetelina; Laurén, Anna; Nelson, Robert; Neitzel, Sonja; Verhaeghe, Tom; van de Merbel, Nico; Wright, Mike; White, Stephen