| 摘要: |
| 抗蠕虫药是指能杀灭或驱除人和动物寄生蠕虫的药物，市场需求巨大。为满足兽药行业发展和寄生虫病防控的实际需要，农业农村部兽药评审中心根据抗蠕虫药临床有效性试验评审现状，充分借鉴兽用药品注册技术要求国际协调会（International Coordination on Harmonization of Technical Requirements for Registration of Veterinary Medical Products, VICH）的兽药研究指导原则和技术评审要求，组织制订了《猪/牛/羊/禽抗蠕虫药临床有效性试验技术指导原则》，科学指导抗蠕虫药研发和评审工作，促进兽药行业高质量发展。本文从《猪/牛/羊/禽抗蠕虫药临床有效性试验技术指导原则》的制订思路和主要内容，科学、系统阐述猪/牛/羊/禽抗蠕虫药临床有效性研究的要点，以期为抗蠕虫药物的研发、申报注册和技术评审提供科学指导和依据。 |
| 关键词: 抗蠕虫药 临床有效性 评审要点 猪/牛/羊/禽 |
| DOI： |
| 投稿时间：2024-02-26修订日期：2024-03-15 |
| 基金项目:“十四五”国家重点研发计划项目“抗寄生虫药缓/控释新工艺研究与产品创制”课题（2023YFD1800904）；公益性重点专项“兽用化学药品注册法规与指导原则研究”（GY202106） |
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| Key points in clinical effectiveness research of anthelmintics in livestock and poultry: A focus on pigs, cattle, sheep, and poultry |
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| (China institute of Veterinary Drug Control) |
| Abstract: |
| Antihelminths are drugs that can kill or expel parasitic worms in humans and animals, and the market demand is huge. In order to meet the actual needs of the development of the veterinary drug industry and the prevention and control of parasitic diseases, the Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs has formulated the Technical Guidelines for Clinical Effectiveness Tests of antihelminths in Pigs/Cattle/Sheep/Poultry according to the current situation of clinical effectiveness test evaluation of antihelminths and fully drawing on the Veterinary drug Research guidelines and technical review requirements of the International Coordination on Harmonization of Technical Requirements for Registration of Veterinary Medical Products（VICH）. Scientific guidance for the research and development and evaluation of anti-helminthic drugs to promote the high-quality development of the veterinary drug industry. Based on the formulation and main contents of Technical Guidelines for Clinical Effectiveness Tests of antihelminths in Pigs/cattle/sheep/poultry, this paper scientifically and systematically expounds the main points of clinical effectiveness studies of antihelminths in pigs/cattle/sheep/poultry, in order to provide scientific guidance and basis for the research and development, registration and technical review of antihelminths. |
| Key words: Antihelminths clinical effectiveness key points for evaluation pigs cattle sheep poultry. |
