ICH M10 Bioanalytical Method Validation Guideline-1 year Later

作者：Faye Vazvaei‐Smith, Enaksha Wickremsinhe, Eric Woolf, Chongwoo Yu · 发表于：The AAPS Journal · 年份：2024 · DOI：10.1208/s12248-024-00974-y · 被引用次数：34 · 研究领域：Biosimilars and Bioanalytical Methods、Statistical Methods in Clinical Trials、Pesticide Residue Analysis and Safety

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.