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European Bioanalysis Forum recommendation on the best practices to demonstrate processed sample stability

机译：欧洲生物分析论坛关于展示加工样本稳定性的最佳实践的建议

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摘要

The European Bioanalysis Forum is providing a proposal on experiments to be conducted if processed samples are to be stored for a period of time, either after an initial injection or if processed samples are to be stored for a period of time prior to their first injection. Using survey information and extensive discussion an insight was gained as to whether the current practices employed during method validation were conducted to scientifically validate actual sample handling conditions or to simply meet a perceived regulatory expectation. The goal of this report is to recommend the adoption of scientifically justified validation experiments that exactly reproduce and processed test sample handling and storage procedures and to introduce some uniformity across the industry.
机译：欧洲生物分析论坛正在提供关于在初始注射或加工样品在首次注射之前储存一段时间之后的处理后的试验的实验的提案。 使用调查信息和广泛的讨论，获得了在方法验证期间采用的现行实践进行了科学验证的实际样品处理条件或简单地达到感知的监管期望。 本报告的目标是建议采用科学合理的验证实验，精确繁殖和加工测试样品处理和存储程序，并在整个行业引入均匀性。

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