BIOLOGICAL TESTING FACILITY

生物测试设施

• 批准号: 8937275
• 负责人: KAREN STEINMETZ
• 金额: $ 65万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-28 至 2015-09-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8937275
• 关键词: Androgens; Animal Testing; Animals; Apidae; Apis; Biological; Biological Testing; Castor Oil; Clinical; Clinical Trials; Contraceptive Agents; Development; Devices; Documentation; Dosage Forms; Drug Formulations; Endocrine; Evaluation; Fertility; Human; Investigation; Nandrolone; Particle Size; Pharmaceutical Preparations; Placebos; Powder dose form; Preparation; Quality Control; Regulation; Route; Safety; Services; Shipping; Ships; System; Testing; Validation; Work; analytical method; capsule; design; human subject; improved; pre-clinical; stability testing; uptake

Biological Testing Facility is designed to permit rapid evaluation of new compositions of matter, drug formulations, delivery systems, and devices for anti-fertility or contraceptive and endocrine activity. The task will support preclinical activities as described in the background. Further, animal support, clinical formulation, clinical batch preparation and release, safety and stability services necessary to provide GMP APis that can be evaluated in the CCTN, including all documentation pursuant to filing an IND that would support batch release and testing in clinical trials will be supported by this task.

生物测试设施旨在快速评估新的物质成分， 用于抗生育或避孕和内分泌活性的药物制剂、输送系统和装置。 该任务将支持背景中描述的临床前活动。进一步地，动物 支持、临床制剂、临床批次制备和放行、安全性和稳定性服务 需要提供可在 CCTN 中评估的 GMP API，包括所有文档 根据提交支持批次发布和临床试验测试的 IND 的规定， 受此任务的支持。