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7节项目总结/摘要 这项关键疗效研究是FDA中心要求的两项疗效研究之一， 兽医完成新动物的有效性技术部分 药物应用。本研究旨在证明雌二醇的疗效， 在饲料中施用（5 ppm）给美国鳗鱼（Anguilla rostrata），以增加 重量.将依地平掺入饲料预混物（A型含药制品）中， 率为0.1%。预混物将被顶部涂覆在鱼饲料上。鳗鱼将被喂给 每天饱食，在整个过程中连续给予雌二醇加药饲料， 处理期从野生捕获的玻璃鳗鱼开始，每条重0.2至0.5 g。的 研究将包括12个实验单元; 6个未处理的对照单元和6个 接受含雌二醇的饲料。每个实验单位最初将由300名 玻璃鳗鱼储存在一个坦克。鳗鱼每隔35天称重一次， 生长，鳗鱼放养密度将保持在最佳水平，通过a）增加水 B）将多条鳗鱼分成另外的一个或多个罐， 类似的尺寸被容纳在一起。最多4个坦克将分配给每个 实验单位所有鳗鱼将在接受雌二醇或雌二醇后315天称重。 给药饲料或未给药饲料，每组的体重增加率将 统计分析。初步实验表明， 为了生产出市场重量的鳗鱼，必须施用含雌二醇的饲料 在不到一年的商业可行期内。

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.