ECA新闻：分析方法验证修订后FDA指南

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ECA新闻：分析方法验证修订后FDA指南


翻译：JULIA 来源：Julia法规翻译
　　Revised FDA Guidance on the validation of analyticalmethods


　　分析方法验证修订后FDA指南


　　The FDA has recently published the final version of their Guidance for Industry "Bioanalytical Method Validation". Extensive changes had been made to the guidance draft from 2013; these are the most important:


　　FDA最近发布了行业指南“生物分析方法验证”最终版本。该版本在2013基础上有大量修改，以下点最为重要：


　　Chapter III, formerly "Chromatographic Methods", has been renamed to "Bioanalytical method development and validation" and supplemented by subsection "Bioanalytical Parameters of CCs und LBAs", which describes a total of nine parameters.


　　第III章，之前的“色谱方法”改名为“生物分析方法开发和验证”，并补充了子部“CC和LBA的生物分析参数”，其中描述了总共9个参数。


　　Chapter IV carries the title "Incurred Sample Reanalysis" (ISR) and, compared to the guidance draft of 2013 (here in chapter V), contains different requirements on how analyses must be repeated in order to verify the original analytical data. For example, samples for repeat analyses may not be pooled. Also, an ISR is expected for all studies submitted in the scope of an NDA, BLA or ANDA.


　　第IV章标题为“试验样品再分析”(ISR)以及相比于2013年指南草案(这里是在第V章)，其中对为了确认原始分析数据而必须重复的分析的要求是不同的。例如，可能不共用样品用于再分析。还有，在NDA、BLA或ANDA范围内提交的所有研究都需要有ISR。


　　The tables included in the Annex have been completely revised and designed more clearly.


　　附录中所包括的表格已完全修改,并设计得更为清晰


　　The glossary has been expanded considerably and contains 31 new terms (from "Autosampler stability" and "Hook effect" to "Zero calibrator").


　　术语已增加为含有31个新术语(从“自动取样品稳定性”和“钩状效应”至“零点校正”)


　　Chapter II "Background" clearly points out theimportance of validated analytical methods, which are indispensable for thesuccessful execution of non-clinical, biopharmaceutical and clinical-pharmacological studies. These analytics offer critical data to demonstrate the safety and efficacy of medicinal products. To ensure that this data iscompletely reliable, the FDA lays down the following key questions:


　　第II章“背景”清晰地指出了验证分析方法的重要性，这对于成功执行非临床、生物药品和临床药品研究是不可或缺的。这些分析提供了关键数据来证明药品的安全性和有效性。为了确保这些数据的完整可靠，FDA订出了以下关键问题：


　　Is the analyte being specifically and selectively captured by the method? Are there any interfering factors?


　　方法对分析物是否具有专属性和选择性?是否有干扰因素?


　　What variabilities are to be expected? How accurate and precise is the procedure?


　　预期有哪些波动性?程序的准确性和精密度如何?


　　What range in measurements provides reliable data? How sensitive is the method (detection and determination limits)?


　　在什么测量范围内会提供可靠数据?方法灵敏度如何(检出限和定量限)?


　　How do the collection, handling and storage of a sample affect the reliability of the data? What steps need to be followed while collecting samples? Must samples be frozen before they are shipped? Storage time and temperature of samples?


　　样品采集、处理和存贮是如何影响数据可靠性的?在采集样品时步骤如何?样品在运送之前是否必须冷冻?样品的存贮时长和温度如何?


　　The FDA expects that these questions are considered for proving the reliability of analytical data through method validation.


　　FDA要求通过方法验证证明分析数据可靠性时考虑这些问题。


　　Following the fit-for-purpose (FFP) concept however,the proportionality should be considered: compared to analytical studies, whichare paramount for gaining a marketing authorisation for a drug product,exploratory studies (e.g. in early stages of development) do not require a complete method validation in consideration of all key questions formulated in this guideline.


　　在适合目的(FFP)概念之下，仍应考虑均衡性：相比于分析研究，对于一个药品来说获得上市许可是至高无上的，考虑到在本指南中阐述的所有关键问题，探索性研究(例如，在开发早期)并不需要有一个完整的方法验证。