PODS - LORAZEPAM - STATUS EPILEPTICUS PEDIATRIC DRUGS

PODS - 劳拉西泮 - 癫痫持续状态儿科药物

• 批准号: 7692543
• 金额: $ 166.47万
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7692543
• 关键词: PODS; LORAZEPAM; STATUS; EPILEPTICUS; PEDIATRIC

The NICHD, as delegated by the NIH, is responsible for implementing the Congressionally-mandated Best Pharmaceuticals for Children Act of 2002, as reauthorized in 2007. The NICHD is responsible for the performance of clinical trials of priority, ¿off patent¿ drugs that are used in children but that lack sufficient pediatric labeling. NICHD responsibility includes administrative activities as well as support, and coordinating support and participation of other ICs in BPCA activities.. In 2003, NICHD awarded a five (5) year contract to Premier Research of Philadelphia PA to provide services for a BPCA Data Coordinating Center (DCC). The purpose of the contract is to establish and support an infrastructure for the coordination of the BPCA pediatric clinical trials. The function of this DCC is to provide regulatory, technical (including statistical and information technology), administrative and logistical support to maintain, coordinate and manage a multi-site network of clinical centers which will conduct pharmacology studies in children.

受美国国立卫生研究院委托，NICHD负责实施国会授权的2002年儿童最佳药品法案，该法案于2007年重新授权。NICHD负责优先的、非专利的、用于儿童但缺乏足够儿科标签的药物的临床试验。NICHD的职责包括行政活动和支持，以及协调支持和参与BPCA活动的其他国际组织。2003年，NICHD与费城的Premier Research公司签订了一份为期5年的合同，为BPCA数据协调中心（DCC）提供服务。该合同的目的是建立和支持协调BPCA儿科临床试验的基础设施。DCC的职能是提供监管、技术（包括统计和信息技术）、行政和后勤支持，以维持、协调和管理一个多站点的临床中心网络，这些临床中心将在儿童中进行药理学研究。