The Safety of AQUAFLOR (50% florfenicol; Type A Medicated Article) Administered in Feed to Marine Finfish Species

%20Safety%20of%20AQUAFLOR%20(50%%20氟苯尼考；%20Type%20A%20Medicated%20Article)%20Administered%20in%20Feed%20to%20Marine%20Finfish%20Species

• 批准号: 10562359
• 负责人: Rodman G Getchell
• 金额: $ 20.47万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10562359
• 关键词: Safety; AQUAFLOR; 50; florfenicol; Type

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 therapeutics to sectors of the aquaculture industry not covered by the original approval. 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. Trials will be conducted with Florfenicol (AQUAFLOR®), which is used to treat specified diseases of fish. Cornell University’s Aquatic Animal Health Program brings a long history of conducting research on fish therapeutants and was funded by 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 AQUAFLOR® to saltwater-reared marine finfish administered in feed to marine finfish species at 0× (0 mg), 1× (15 mg), 3× (45 mg), or 5× (75 mg) the maximum proposed therapeutic dose of 15 mg florfenicol/kg fish/day for 20 consecutive days (2× the proposed therapeutic treatment duration of 10 consecutive days). The target animal safety study of AQUAFLOR® will be conducted with juvenile marine finfish species. 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 AQUAFLOR® for the control of mortality in seawater-reared finfish due to yellowmouth associated with Tenacibaculum maritimum.

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）。该项目解决了增加治疗可用性的需求 水产养殖业的部门未得到原始批准。缺乏批准的海洋药物 Finfish生产商威胁着这些集体行业的增长和长期生存能力和安全性 尽管已经将一些新的水产养殖药物添加到集体鳍鱼中。 在过去的10 - 15年中，水上动物的FDA批准药物的总数仍然非常有限。 康奈尔大学水上动物健康计划和USFWS水上动物药物的研究人员 批准合作伙伴关系（AADAP）计划提议继续进行协作以进行研究以增加 可用于使美国水产养殖社区受益的安全有效药物的数量。试验将 用佛罗里芬酸（Aquaflor®）进行，用于治疗指定的鱼类疾病。康奈尔 大学的水生动物健康计划带来了有关鱼类治疗研究的悠久历史 并在过去两年中由NIFA资助。此赠款申请提案将完成 与研究人员，病理学家，统计学家和质量保证人员合作 康奈尔大学兽医学院和AADAP。这项研究将评估 Aquaflor®至盐水饲养的海洋鳍，在0×（0 mg）的饲料中给予海洋鳍鱼类，1× （15毫克），3×（45 mg）或5×（75 mg）最大拟议的治疗剂量为15 mg florfenicol/kg鱼/天/天 连续20天（2倍连续10天提出的治疗持续时间）。目标动物 Aquaflor®的安全研究将与青少年海洋鳍鱼类进行。这些安全的结果 研究，如果被FDA/CVM接受，将用于完成TAS技术部分数据要求 海洋鳍鱼并支持向FDA/CVM提出新的动物药物申请，以批准使用Aquaflor®用于 由于黄嘴与替纳氏杆菌相关的海水饲养鳍鱼死亡率的控制。