The Safety of AQUI-S 20E (10% Eugenol) as a Sedative on Clownfish at Cornell University

项目摘要/摘要 生成和传播数据，用于安全有效的治疗应用，供大、中、小剂量使用 物种或用于次要物种是FDA/CVM的次要使用和次要物种办公室的优先事项 药物开发(OMUMS)。该项目解决了增加鱼类镇静剂的供应的需要 海生鳍鱼。缺乏经批准的海洋鳍鱼生产商的药物正在威胁到鱼类的生长和长期 这些集体工业的生存能力和我们粮食供应的安全。尽管一些新的水产养殖药物 在过去的10-15年里被添加到集体鱼群的药箱里，FDA的总数-- 批准用于水生动物的药物仍然非常有限。康奈尔大学水生动物研究人员 健康计划和美国食品和药物管理局水生动物药物批准伙伴关系(AADAP)计划提议 继续合作进行研究，以增加可使用的安全有效药物的数量 以造福美国水产养殖界。将进行以丁香酚为基础的目标动物安全性研究 镇静剂(水-S 20E®)。康奈尔大学的水生动物健康项目带来了悠久的历史 在过去的两年里，美国农业部NIFA资助了鱼类疗法的研究。这项拨款申请 提出将与研究人员、病理学家、统计学家和 康奈尔大学兽医学院和AADAP的质量保证人员。这 研究将评估Aqui-S®20E对海水养殖的海水养殖鱼类的安全性，当过度暴露于 最高建议有效剂量(1倍)或1.5倍最高建议有效剂量。目标动物安全 AQI-S 20E®将以小丑鱼为研究对象，小丑鱼是中国最受欢迎的观赏物种之一 如果FDA/CVM接受这些安全性研究的结果，美国将用于完成TAS技术 部分数据要求海洋鳍鱼和支持新的动物药物申请到FDA/CVM批准 使用AQI-S 20E®作为海洋鱼类的镇静剂。

Project Summary / Abstract Generation and dissemination of data for safe and effective therapeutic applications for minor use in major species or for use in minor species is a priority of the FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS). This project addresses the need to increase the availability of fish sedatives for marine finfish. The lack of approved drugs for marine finfish producers is threatening the growth and long-term viability of these collective industries and the security of our food supply. Although some new aquaculture drugs have been added to the collective finfish “medicine chest” in the past 10-15 years, the total number of FDA- approved drugs for aquatic animals is still very limited. Researchers within the Cornell University Aquatic Animal Health Program and USFWS Aquatic Animal Drug Approval Partnership (AADAP) program are proposing to continue a collaboration to conduct studies to increase the number of safe and effective drugs that can be used to benefit the U.S. aquaculture community. A target animal safety study will be conducted with a eugenol-based sedative (AQUI-S 20E®). Cornell University’s Aquatic Animal Health Program brings a long history of conducting research on fish therapeutants and was funded by USDA NIFA during the last two years. This grant application proposes tasks that will be completed in partnership with the team of researchers, pathologists, statisticians, and quality assurance personnel at both the Cornell University College of Veterinary Medicine and AADAP. This study will evaluate the safety of AQUI-S®20E to saltwater-reared marine finfish when overexposed to either the highest proposed efficacious dose (1×) or 1.5× the highest proposed efficacious dose. The target animal safety study of AQUI-S 20E® will be conducted with clownfish, one of the most popular ornamental species cultured in the U.S. The results of these safety studies, if accepted by FDA/CVM, will be used to complete the TAS technical section data requirements for marine finfish and support a New Animal Drug Application to FDA/CVM to approve the use of AQUI-S 20E® as a sedative for marine finfish.