中国兽药杂志2026，Vol.60Issue(4)：1-6,6.DOI:10.11751/ISSN.1002-1280.2026.4.01
兽药生物样品定量分析方法的建立、验证及评审中的常见问题
Development,Validation and Common Issues of Evaluation of Quantitative Analytical Methods for Veterinary Drug in Biological Samples
孙雷 1王亦琳 1叶妮 1沈昕 1段聪 1郭翱 1杜雨 1徐倩1
作者信息
- 1. 中国兽医药品监察所(农业农村部兽药评审中心),北京 100081
- 折叠
摘要
Abstract
The quantitative analysis of drug in biological samples such as animal plasma has become an important part of the veterinary drug research and development process.It can provide accurate and reliable data for veterinary drug trials including pharmacokinetics,toxicokinetics and bioequivalence,and help regulatory decisions related to the safety and effectiveness of veterinary drugs.This article sorts out the development,validation and common issues of evaluation of quantitative analytical methods for veterinary drug in biological samples,aiming to provide a reference for the research and development and registration of new veterinary drugs in China.关键词
兽药/生物样品/定量分析方法/建立/验证/常见问题Key words
veterinary drugs/biological samples/quantitative analytical methods/development/validation/common issues分类
医药卫生引用本文复制引用
孙雷,王亦琳,叶妮,沈昕,段聪,郭翱,杜雨,徐倩..兽药生物样品定量分析方法的建立、验证及评审中的常见问题[J].中国兽药杂志,2026,60(4):1-6,6.
