ICH M10 生物分析方法验证指南-1 年后

The AAPS Journal Pub Date : 2024-09-12 DOI:10.1208/s12248-024-00974-y

Faye Vazvaei-Smith, Enaksha Wickremsinhe, Eric Woolf, Chongwoo Yu

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摘要

国际人用药品技术要求协调理事会（ICH）于 2022 年 5 月通过了题为 "生物分析方法验证和研究样品分析 "的 M10 准则。2023 年 10 月，即 ICH M10 指南通过约一年后，在 AAPS PharmSci 360 会议期间举行了一次 "热点话题 "会议，讨论该指南的实施。会议重点讨论了生物分析界认为具有挑战性或在指南中含糊不清的项目。这些主题包括交叉验证、平行性、比较生物利用度研究、复方药物稳定性、内源性分析物生物分析和稀释质量控制。此外，还从监管角度介绍了该指南。本报告提供了热点话题会议的摘要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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ICH M10 Bioanalytical Method Validation Guideline-1 year Later

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.

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The AAPS Journal

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