PEDIATRIC PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF

儿科药代动力学和药效学研究

• 批准号: 8356695
• 负责人: ALOYSIA SCHWABE
• 金额: $ 0.44万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356695
• 关键词: Age; Childhood; Clinical Research; Dose; Drug Kinetics; Enrollment; Funding; Grant; National Center for Research Resources; Pharmacodynamics; Principal Investigator; Research; Research Infrastructure; Resources; Site; Source; Titrations; United States National Institutes of Health; age group; cost; experience; open label

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT This is an open-label, multiple-dose, ascending dose study in approximately 85 subjects in 3 age groups (ages greater than 2 to less than 6 years, 6 to less than 12 years and 12 to 16 years), to be conducted at approximately nine investigative sites with access to general clinical research centers (GCRCs) with pediatric experience. Each of these sites will enroll approximately 12 subjects (total of approximately 108 subjects) to allow for discontinuation of subjects prior to study completion and titration of a sufficient number of subjects to each dose level.

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 摘要 这是一项开放标签、多次给药、剂量递增研究，在3个年龄组（年龄大于2岁至小于6岁、6岁至小于12岁和12岁至16岁）约85例受试者中进行，将在约9家可访问具有儿科经验的一般临床研究中心（GCRC）的研究中心进行。每个研究中心将入组约12例受试者（总计约108例受试者），以允许在研究完成前中止受试者并滴定足够数量的受试者 每个剂量水平的受试者数量。