标题： 分析方法的风险管理：兼顾方法目标、验证阶段和常规决策规则 显示英文标题

标题： Risk management for analytical methods: conciliating objectives of methods, validation phase and routine decision rules

摘要： 在涉及化学或生物的行业，例如制药业、化工行业或食品工业中，分析方法是所有生产和使用材料的必要手段和工具。 如果一个分析方法的质量存疑，那么基于这些测量所做出的所有决策都值得怀疑。 出于这些原因，能够评估分析方法的质量远不止是一个统计学上的挑战；它关乎道德和良好的商业实践。 为了解决这个问题，许多法规文件已经发布，特别是在制药行业的 ICH 和 FDA 文件（FDA, 1995, 1997, 2001）。 显示英文摘要

摘要： In the industries that involved either chemistry or biology, such as pharmaceutical industries, chemical industries or food industry, the analytical methods are the necessary eyes and hear of all the material produced or used. If the quality of an analytical method is doubtful, then the whole set of decision that will be based on those measures is questionable. For those reasons, being able to assess the quality of an analytical method is far more than a statistical challenge; it's a matter of ethic and good business practices. Many regulatory documents have been releases, primarily ICH and FDA documents in the pharmaceutical industry (FDA, 1995, 1997, 2001) to address that issue.