兽用化学药品血药浓度法生物等效性试验技术指导原则简述  

Overview of Guideline of Bioequivalence: Blood Level Bioequivalence Study for Veterinary Pharmaceutical Products

作　　者：李丹[1] 董义春[1] 苏富琴[1] 徐倩[1] 杨大伟[1] 刘艳华[1] 汪霞[1] 梁先明[1] LI Dan;DONG Yi-chun;SU Fu-qin;XU Qian;YANG Da-wei;LIU Yan-hua;WANG Xia;LIANG Xian-ming(China Institute of Veterinary Drug Control,Beijing 100081,CHINA)

机构地区：[1]中国兽医药品监察所,北京100081

出　　处：《中国兽药杂志》2022年第12期69-74,共6页Chinese Journal of Veterinary Drug

基　　金：中国兽医药品监察所兽药行业公益性重点专项“兽药评审技术规范研究”(GY202023)。

摘　　要：血药浓度法生物等效性试验是兽药生物等效性研究的重要方法。为科学规范兽用化学药品生物等效性研究,保障兽药安全、有效、质量可控,在已发布实施的《兽用化学药品生物等效性试验指导原则》基础上,农业农村部兽药评审中心参考相关最新技术指导原则,结合国内兽药研究现状,修订发布了《兽用化学药品血药浓度法生物等效性试验技术指导原则》。本文针对该指导原则的适用范围、试验设计的内容进行阐述,旨在加强企业或相关临床试验机构对此指导原则的理解,对生物等效性试验的有效开展提供指导与帮助。Blood level bioequivalence study is one of the key method in veterinary medicine comparison test. In order to scientifically standardize the research on bioequivalence of veterinary chemicals and ensure the safety, effectiveness and quality control of veterinary drugs, the Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs referred to relevant latest technical guidelines and combined with the research status of veterinary drugs in China on the basis of the published and implemented Guidelines on Bioequivalence Test of Veterinary Chemical Drugs. The Technical Guidelines for bioequivalence Test of Veterinary Chemicals by blood drug concentration method were revised and published. In this paper, the scope of application of the guidelines and the content of trial design were described, aiming to strengthen the understanding of the guidelines by enterprises or relevant clinical trial institutions, and to provide guidance and help for the effective development of bioequivalence tests.

关 键 词：药代动力学 血药浓度法 生物等效性 兽药 

分 类 号：S851.66[农业科学—预防兽医学]