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VICH血药法生物等效性指导原则概述
苏富琴,徐倩,梁先明,曹兴元
0
(中国兽医药品监察所 北京)
摘要:
血药法生物等效性试验是开展兽药比对试验工作的重要手段之一。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。
关键词:  兽药注册技术要求国际协调合作组织  药代动力学  生物等效性  兽药
DOI:
投稿时间:2017-05-24修订日期:2017-11-30
基金项目:
Overview of VICH Guaidline of Bioequivalence: Blood Level Bioequivalence Study for Veterinary Pharmacetical Products
(China Institute of Veterinary Drug Control)
Abstract:
Blood level bioequivalence study is one of the key methord in veterinary 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), study design considerations and statistical principles have been described in detail in order to unify the harmonized guideline 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.
Key words:  International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)  pharmacokinetics  bioequivalence(BE)  veterinary pharmacetical products

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