CLINICAL TRIAL OPERATIONS

临床试验操作

• 批准号: 6358847
• 负责人: JOHN D ROACHE
• 金额: $ 97.09万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2004-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6358847
• 关键词: clinical trials; cocaine; drug abuse; drug abuse therapy; health science research support; pharmacokinetics

This contract will provide a network of three clinical trial sites that will provide clinical trials services for the conduct of Phase I and II clinical trials and clinical pharmacology studies. University of Cincinnati is one of three sites in this network. The clinical sites will evaluate systematically the clinical utility of potential pharmacotherapeutic compounds in order to develop effective medications for the treatment of drug abuse and addiction. Specifically. Pharmacotherapeutic compounds to reduce the use of cocaine and other stimulants will be investigated. The results of these clinical trials will be the basis to advance the candidate compounds for further medication development (i.e., Phase III clinical trial) and ultimately submitted to the FDA in support of a New Drug Application (NDA) submission. The major emphasis of this contract shall be on clinical trials to evaluate the clinical pharmacology and efficacy and safety profiles of the candidate compounds.

该合同将提供一个由三个临床试验地点组成的网络，为进行第一阶段和第二阶段临床试验和临床药理学研究提供临床试验服务。辛辛那提大学是这个网络的三个站点之一。临床站点将系统地评估潜在的药物治疗化合物的临床效用，以开发治疗药物滥用和成瘾的有效药物。具体地说。将对减少可卡因和其他兴奋剂使用的药物治疗化合物进行调查。这些临床试验的结果将作为进一步药物开发(即第三阶段临床试验)的候选化合物的基础，并最终提交给FDA以支持新药申请(NDA)的提交。本合同的主要重点应放在临床试验上，以评估候选化合物的临床药理学和有效性和安全性。