概念,重要性,和生物分析方法验证的应用已经讨论了很长时间,并且生物分析方法的验证在被常规使用之前被广泛认为是关键。自2001年以来,美国食品和药物管理局(USFDA)发布的每个指南都被引用;可能是欧洲医疗机构(EMA)欧洲,巴西国家卫生监测机构(ANVISA)日本厚生劳动省(MHLW)或任何其他参考生物分析方法验证的指南。12年后,USFDA于2013年发布了新的指南草案,其中涵盖了生物分析方法验证中遇到的最新参数或主题,并在全球范围内实现了生物分析方法验证的统一。尽管监管机构普遍同意,验收标准和方法存在显著差异。本评论强调了这些变化,全球主要监管机构发布的生物分析方法验证指南之间的相似性和比较。此外,其他评估参数,如矩阵效应,已经讨论了引起的样品再分析,包括其他稳定性方面,以易于设计生物分析方法及其符合大多数药物管理局指南的验证。
The concepts, importance, and application of bioanalytical method validation have been discussed for a long time and validation of bioanalytical methods is widely accepted as pivotal before they are taken into routine use. United States Food and Drug Administration (USFDA)
guidelines issued in 2001 have been referred for every
guideline released ever since; may it be European Medical Agency (EMA) Europe, National Health Surveillance Agency (ANVISA) Brazil, Ministry of Health and Labour Welfare (MHLW) Japan or any other
guideline in reference to bioanalytical method validation. After 12 years, USFDA released its new draft
guideline for comments in 2013, which covers the latest parameters or topics encountered in bioanalytical method validation and approached towards the harmonization of bioanalytical method validation across the globe. Even though the regulatory agencies have general agreement, significant variations exist in acceptance criteria and methodology. The present review highlights the variations, similarities and comparison between bioanalytical method validation
guidelines issued by major regulatory authorities worldwide. Additionally, other evaluation parameters such as matrix effect, incurred sample reanalysis including other stability aspects have been discussed to provide an ease of access for designing a bioanalytical method and its validation complying with the majority of drug authority guidelines.