VICH血药法生物等效性指导原则概述
发布时间：2018-09-05 16:00
【摘要】：VICH是指兽药注册技术要求国际协调合作组织。血药法生物等效性试验是兽药等效性研究的重要方法。VICH血药法生物等效性指导原则介绍了除多次采血困难的靶动物(如蜂、鱼)的动物血药法生物等效性的实验试验建议,使基本药代动力学试验、生物等效性试验设计和统计分析原则等在VICH地区得到互认。该指导原则2016年8月开始实施。
[Abstract]:VICH refers to the registration of veterinary drugs technical requirements for international coordination and cooperation organization. Blood drug bioequivalence test is an important method in the study of veterinary drug equivalence. The guiding principle of blood drug bioequivalence is introduced in this paper. The experimental recommendations on the bioequivalence of blood drug method for target animals (such as bees and fish) which are difficult to collect blood from many times are introduced. The basic pharmacokinetic test, bioequivalence test design and statistical analysis principles are recognized in VICH region. The guidelines were implemented in August 2016.
【作者单位】： 中国兽医药品监察所;中国农业大学动物医学院;
【分类号】：S851.66
本文编号：2224761
[Abstract]:VICH refers to the registration of veterinary drugs technical requirements for international coordination and cooperation organization. Blood drug bioequivalence test is an important method in the study of veterinary drug equivalence. The guiding principle of blood drug bioequivalence is introduced in this paper. The experimental recommendations on the bioequivalence of blood drug method for target animals (such as bees and fish) which are difficult to collect blood from many times are introduced. The basic pharmacokinetic test, bioequivalence test design and statistical analysis principles are recognized in VICH region. The guidelines were implemented in August 2016.
【作者单位】： 中国兽医药品监察所;中国农业大学动物医学院;
【分类号】：S851.66
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