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OA
Development,Validation and Common Issues of Evaluation of Quantitative Analytical Methods for Veterinary Drug in Biological Samples
动物血浆等生物样品中药物的定量分析已成为兽药研发过程中的重要内容,可为兽药药代动力学、毒代动力学和生物等效性等试验提供准确可靠的数据,并有助于兽药安全性和有效性相关监管决策.本文就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进行梳理,旨在为我国新兽药的研发和注册提供参考.
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.
孙雷;王亦琳;叶妮;沈昕;段聪;郭翱;杜雨;徐倩
中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081
医药卫生
兽药生物样品定量分析方法建立验证常见问题
veterinary drugsbiological samplesquantitative analytical methodsdevelopmentvalidationcommon issues
《中国兽药杂志》 2026 (4)
1-6,6
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