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

%20安全%20of%20AQUI-S%2020E%20(10%%20丁香酚)%20as%20a%20镇静%20on%20小丑鱼%20at%20康奈尔%20大学

• 批准号: 10329055
• 负责人: Rodman G Getchell
• 金额: $ 13.71万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2022-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10329055
• 关键词: Safety; AQUI; 20E; 10; Eugenol

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.

项目总结/摘要 生成和传播安全和有效的治疗应用数据，供少数人在主要疾病中使用 FDA/CVM的次要用途和次要种属动物办公室优先考虑 药物开发（OMUMS）。该项目解决了增加鱼类镇静剂供应的需要， 海洋鳍鱼海洋鱼类生产者缺乏批准的药物， 这些集体工业的可行性和我们的粮食供应安全。虽然一些新的水产养殖药物 在过去的10-15年里，FDA- 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所的研究人员 健康计划和USFWS水生动物药物批准伙伴关系（AADAP）计划建议， 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。靶动物安全性研究将使用基于丁香酚的 镇静剂（AQUI-S 20 E ®）。康奈尔大学的水生动物健康计划带来了悠久的历史， 在过去的两年里，美国农业部NIFA资助了鱼类治疗剂的研究。这份资助申请 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® 20 E对海水养殖的海洋鱼类的安全性， 最高拟定有效剂量（1×）或1.5×最高拟定有效剂量。靶动物安全性 AQUI-S 20 E ®的研究将与小丑鱼进行，小丑鱼是中国最受欢迎的观赏鱼种之一。 如果FDA/CVM接受这些安全性研究的结果，则将用于完成TAS技术 海洋鳍鱼的数据要求，并支持向FDA/CVM批准的新兽药申请 使用AQUI-S 20 E ®作为海洋鱼类的镇静剂。