分析方法的风险管理：方法、验证阶段和常规决策规则的协调目标
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中，如制药工业、化学工业或食品工业，分析方法是所有生产或使用的材料的必要眼睛和耳朵。如果一种分析方法的质量是可疑的，那么基于这些措施的整套决策也是可疑的。由于这些原因，能够评估分析方法的质量远不止是一个统计挑战;这是一个道德和良好商业惯例的问题。已经发布了许多监管文件，主要是制药行业的ICH和FDA文件（FDA，1995，1997，2001），以解决该问题。
英文摘要：
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.
机构、总结、中文摘要均由AI分析而来，可能存在错误，请以论文正文为准。
