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.

项目摘要 /摘要 数据生成和传播数据，以进行安全有效的治疗应用，以较小 物种或用于次要物种是FDA/CVM次要使用和次要物种动物办公室的优先事项 药物开发（OMUMS）。该项目解决了增加鱼类镇静剂的需求 海洋鳍鱼。缺乏用于海洋鳍鱼类生产商的批准药物正在威胁增长和长期 这些集体行业的生存能力和我们的粮食供应的安全性。虽然有一些新的水产养殖药 在过去的10 - 15年中，已添加到集体鳍“药箱”中 水上动物的批准药物仍然非常有限。康奈尔大学水生动物的研究人员 健康计划和USFWS水上动物药物批准合作伙伴关系（AADAP）计划正在提议 继续进行协作以进行研究，以增加可以使用的安全有效药物的数量 使美国水产养殖社区受益。目标动物安全研究将使用基于欧生醇的 镇静剂（Aqui-S20E®）。康奈尔大学的水生动物健康计划带来了悠久的指导历史 关于鱼类治疗的研究，在过去的两年中由USDA NIFA资助。此赠款申请 提案任务将与研究人员，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对盐水饲养的海洋鳍鱼的安全性。 提出的最高有效剂量（1×）或1.5倍最高提议的有效剂量。目标动物安全 Aqui-S20E®的研究将与小丑鱼进行，这是培养的最流行的观赏物种之一 美国这些安全研究的结果，如果被FDA/CVM接受，将用于完成TAS技术 海洋鳍鱼的部分数据要求，并支持向FDA/CVM批准的新动物药物申请 使用Aqui-S20E®用作海洋鳍鱼的镇静剂。