Bioanalysis, a key supporting function for generating data for pre‐clinical and clinical studies in drug development, is under the regulation of local agencies as well as global organizations to ensure the data integrity and quality in submission. As major regulatory agencies and organizations, the US Food and Drug Administration, the European Medicines Agency and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use have been updating their industry guidance for bioanalytical method validation, to keep up with the development new modalities, technologies and regulations. This article summarizes the recent updates and any clarifications and controversies triggered by those updates. Perspectives and recommendations are given based on our own experience as well as commonly accepted practice in the bioanalytical community.

中文翻译：

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主要监管机构和组织对生物测定方法验证的色谱分析指南的更新，澄清和争议的观点

生物分析是为药物开发的临床前和临床研究生成数据的关键支持功能，它受到地方机构和全球组织的监管，以确保数据完整性和提交质量。作为主要的监管机构和组织，美国食品药品监督管理局，欧洲药品管理局和国际人用药品技术要求协调委员会已经在更新其生物分析方法验证的行业指南，以适应最新的发展。形式，技术和法规。本文总结了最新更新以及这些更新引发的任何澄清和争议。