Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics, Merck & Co., Inc., West Point, Pennsylvania, USA.
Bioassay and Biomarker Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
AAPS J. 2024 Sep 12;26(5):103. doi: 10.1208/s12248-024-00974-y.
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted Guideline M10 entitled "Bioanalytical Method Validation and Study Sample Analysis" in May 2022. In October 2023, approximately one year after the adoption of the ICH M10 guideline, a "Hot Topic" session was held during the AAPS PharmSci 360 meeting to discuss the implementation of the guideline. The session focused on items the bioanalytical community felt were challenging to implement or ambiguous within the guideline. These topics included cross-validation, parallelism, comparative bioavailability studies, combination drug stability, endogenous analyte bioanalysis, and dilution QCs. In addition, the regulatory perspective on the guideline was presented. This report provides a summary of the Hot Topic session.
国际人用药品注册技术协调会（ICH）于 2022 年 5 月通过了题为“人用药物的生物分析方法验证和研究样品分析”的指南 M10。2023 年 10 月，即在 ICH M10 指南通过大约一年后，AAPS PharmSci 360 会议期间举行了一次“热点话题”会议，以讨论该指南的实施情况。会议重点讨论了生物分析界认为在指南中难以实施或模棱两可的项目。这些主题包括交叉验证、平行性、比较生物利用度研究、组合药物稳定性、内源性分析物生物分析和稀释 QC。此外，还介绍了监管机构对该指南的看法。本报告提供了热点话题会议的总结。
