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

研究及相关其他项目信息： 第七节项目总结/摘要 这项关键的疗效研究是FDA中心要求进行的两项疗效研究之一 兽医完成新动物功效技术科 药物申请。这项研究是为了证明雌二醇在以下情况下的疗效 在饲料中(5ppm)给予美洲鳗(Anguilla Rostrata)，以提高 重量。雌二醇将被加入饲料预混料(A类药物制品)中 这一比率为0.1%。预混料将在鱼饲料上涂上一层。鳗鱼将被喂给 每天服用含雌二醇的饲料，在整个过程中持续服用 治疗期从野生捕获的玻璃鳗开始，每条重0.2至0.5克。这个 研究将包括12个实验单位；6个未经处理的对照单位和6个 接受含雌二醇的饲料。每个实验单位最初将由300人组成 玻璃鳗鱼放入1个水箱。鳗鱼将每隔35天称重一次，因为它们 生长，鳗鱼的放养密度将通过a)添加更多的水来保持在最佳水平 进入水箱，b)将鳗鱼数量分解到额外的水箱(S)，c)分级，使鳗鱼的 差不多大小的房子都放在一起。每辆最多分配4辆坦克 实验单位。所有鳗鱼在服用雌二醇315天后称重。 加药饲料或非加药饲料和每组的增重率分别为 统计分析。初步实验表明，连续 为了生产市场体重的鳗鱼，需要添加雌二醇的饲料 在商业上可行的不到一年的时间内。

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.