Department of Drug Metabolism and Pharmacokinetics, Biogen, 225 Binney St, Cambridge, MA, 02142, USA.
Biomed Chromatogr. 2021 Jan;35(1):e5030. doi: 10.1002/bmc.5030. Epub 2020 Dec 9.
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.
生物分析是药物开发中生成临床前和临床研究数据的关键支持功能，受到当地机构和全球组织的监管，以确保提交数据的完整性和质量。作为主要的监管机构和组织，美国食品和药物管理局、欧洲药品管理局和人用药物技术要求国际协调理事会一直在更新其生物分析方法验证的行业指南，以跟上新方法、技术和法规的发展。本文总结了最近的更新以及这些更新所引发的任何澄清和争议。根据我们自己的经验以及生物分析界普遍接受的做法，给出了观点和建议。
