VICH血药法生物等效性指导原则概述

Overview of VICH Guaidline of Bioequivalence: Blood Level Bioequivalence Study for Veterinary Pharmacetical Products

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。

VICH is the abbreviation of International Cooperation on Harmonization of Technical Requirements forRegistration of Veterinary Medicinal Products. Blood level bioequivalence study is one of the key methord inveterinary medical comparison test. We summerized the key points of the VICH Guaidline of Bioequivalence：blood level bioequivalence study for veterinary pharmacetical products. The basic pharmacokinetics （PK）, studydesign considerations and statistical principles have been described in detail in order to unify the harmonizedguideline in the global veterinary community. Animal species from which multiple blood sampling is difficult （e.g.,fish, honeybee etc.） are outside the scope of this guideline which is implemented from August 2016.