Pivotal Study to Demonstrate the Effectiveness of Estradiol Administered in Feed to American Eels (Anguilla rostrata) for Increased Rate of Weight Gain, Protocol No. NE-002

证明在美国鳗鱼（Anguilla rostrata）饲料中添加雌二醇可提高体重增加率的有效性的关键研究，方案编号 NE-002

• 批准号: 9750312
• 负责人: Neil Ross
• 金额: $ 15万
• 依托单位: NOVAEEL, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-20 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9750312
• 关键词: Pivotal; Study; Demonstrate; Effectiveness; Estradiol

Research & Related Other Project Information: Section 7 Project Summary/Abstract This pivotal efficacy study is one of two efficacy studies required by the FDA Center for Veterinary Medicine to complete the effectiveness technical section of the new animal drug application. This study is to demonstrate the efficacy of estradiol when administered in feed (5 ppm) to American eels (Anguilla rostrata) to increase the rate of weight. Estradiol will be incorporated into a feed premix (Type A Medicated Article) at the rate of 0.1%. The premix will be top-coated onto fish feed. Eels will be fed to satiation daily with estradiol-medicated feed administered continuously throughout the treatment period starting with wild-caught glass eels that weigh 0.2 to 0.5 g each. The study will consist of 12 experimental units; 6 untreated control units and 6 units that receive estradiol-medicated feed. Each experimental unit will initially consist of 300 glass eels stocked into 1 tank. Eels will be weighed at 35-day intervals and as they grow, eel stocking density will be maintained at optimal levels by a) adding more water into the tank, b) splitting eel numbers into additional tank(s), c) grading so that eels of similar sizes are housed together. A maximum of 4 tanks will be assigned to each experimental unit. All eels will be weighed after 315 days of receiving either estradiol medicated feed or unmedicated feed and the rate of weight gain for each group will be statistically analyzed. Preliminary experiments have shown that continuous administration of estradiol-medicated feed is necessary to produce market weight eels in a commercially feasible period of less than one year.

研究及相关其他项目信息： 第 7 节 项目概要/摘要 这项关键功效研究是 FDA 中心要求的两项功效研究之一 兽医完成新动物功效技术部分 药物应用。本研究旨在证明雌二醇在以下情况下的功效： 在美国鳗鱼（Anguilla rostrata）饲料中施用（5 ppm），以提高 重量。雌二醇将被纳入饲料预混料（A 类药物制品）中 0.1%的税率。预混料将被涂在鱼饲料上。鳗鱼将被喂给 每天连续喂食含雌二醇的饲料以达到饱腹感 治疗期从野生捕获的玻璃鳗开始，每条重 0.2 至 0.5 克。这 研究将由12个实验单位组成； 6 个未经处理的对照单元和 6 个经处理的单元 接受含雌二醇的饲料。每个实验单元最初将由 300 个 玻璃鳗鱼放入 1 个水箱中。鳗鱼将每隔 35 天称重一次，因为它们 生长时，鳗鱼放养密度将通过 a) 添加更多水保持在最佳水平 放入水箱中，b) 将鳗鱼数量分成额外的水箱，c) 分级，以便 相似尺寸的安装在一起。每个最多可分配 4 辆坦克 试点。所有鳗鱼将在接受雌二醇 315 天后称重 加药饲料或不含药饲料以及每组的体重增加率 进行统计分析。初步实验表明，连续 为了生产上市重量的鳗鱼，需要使用含雌二醇的饲料 在商业上可行的时间内少于一年。