North Carolina Collaborative PPRU Network

北卡罗来纳州合作 PPRU 网络

• 批准号: 6728117
• 负责人: ROSS E MCKINNEY
• 金额: $ 36.52万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-03-08 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6728117
• 关键词: children; clinical research; clinical trials; cooperative study; drug design /synthesis /production; drug metabolism; drug receptors; drug screening /evaluation; human subject; human therapy evaluation; membrane transport proteins; patient oriented research; pediatrics; pharmacogenetics; pharmacokinetics; pharmacology; proteomics; technology /technique development; training

DESCRIPTION (provided by applicant): The North Carolina Collaborative Pediatric Pharmacology Research Unit (NCC-PPRU) will be composed of personnel from Duke University and the University Of North Carolina (UNC). The NCC-PPRU will help develop new medications with pediatric indications and increase the availability of pediatric pharmacokinetic data. Faculty leadership will ensure the integration of the infrastructure of the 2 institutions. The NCC-PPRU program will have 6 specific aims: 1) To conduct studies in bioavailability, metabolism pharmacokinetics, pharmacodynamics, and the safety and efficacy of new and licensed drugs. These studies, led by Dr. Pollack (UNC), will rely on the infrastructure of the UNC School of Pharmacy Quantitative Chromatography and PKIPD Laboratories. 2) To form partnerships with industry and gather the necessary clinical data to support FDA approval of pediatric indications for new and previously licensed medications. The accrual of patients into collaborative studies developed by the PPRU Network will be led by Dr. McKinney (Duke) and will grow from a mature interdisciplinary clinical trials group at Duke University-the Pediatric Clinical Research Program. Dr. McKinney, assisted by Drs. Benjamin (Duke) and Retsch-Bogart (UNC), will integrate the clinical departments of both institutions. Drs. Schulman (Duke) and Retsch-Bogart will lead the effort to coordinate the General Clinic Research Centers' resources. Drs. Benjamin and Li (Duke) will integrate the coordinating center resources within the Duke Clinical Research institute. 3) To develop novel approaches and innovative technique in pediatric pharmacology. Dr. Pollack will lead these efforts; Dr. Walson (Senior Consultant, Cincinnati) will facilitate a partnership with the Center for Education and Research in Therapeutics to achieve this aim. 4) To conduct studies on the developmental characteristics of drug-metabolizing enzymes, transporters, and receptors. Dr. LeCluyse (UNC) will lead these efforts in the Drug Metabolism/Transport Laboratory. 5) To apply pharmacogenomic and proteomic tools in pediatric clinical studies. Dr. Mangum (Duke) will lead this collaborative effort in conjunction with the genomics institutes of Duke and IJNC. 6) To train physicians and pharmacologists in clinical and developmental pharmacology: the centerpiece will be a 3-year pediatric pharmacology fellowship. Drs. Brouwer and Lindley (UNC) will lead this program.

描述（由申请人提供）： 北卡罗来纳州儿科药理学合作研究小组（NCC-PPRU）将由杜克大学和北卡罗来纳大学（UNC）的人员组成。 NCC-PPRU 将帮助开发具有儿科适应症的新药物，并增加儿科药代动力学数据的可用性。教师领导将确保两个机构基础设施的整合。 NCC-PPRU 计划有 6 个具体目标： 1) 开展新药和许可药物的生物利用度、代谢药代动力学、药效学以及安全性和有效性研究。这些研究由 Pollack 博士（北卡罗来纳大学）领导，将依赖北卡罗来纳大学药学院定量色谱和 PKIPD 实验室的基础设施。 2) 与行业建立合作伙伴关系并收集必要的临床数据，以支持 FDA 批准新的和先前许可的药物的儿科适应症。 PPRU 网络开发的合作研究项目将由麦金尼博士（杜克大学）领导，并将由杜克大学成熟的跨学科临床试验小组——儿科临床研究项目发展而来。麦金尼博士，由博士协助。本杰明（杜克大学）和雷奇-博加特（北卡罗来纳大学）将整合两个机构的临床部门。博士。 Schulman（杜克大学）和 Retsch-Bogart 将领导协调普通临床研究中心资源的工作。博士。本杰明和李（杜克大学）将整合杜克大学临床研究所内的协调中心资源。 3）开发儿科药理学的新方法和创新技术。波拉克博士将领导这些工作；沃尔森博士（辛辛那提高级顾问）将促进与治疗学教育和研究中心的合作，以实现这一目标。 4) 开展药物代谢酶、转运蛋白和受体发育特征的研究。 LeCluyse 博士（北卡罗来纳大学）将领导药物代谢/转运实验室的这些工作。 5) 将药物基因组学和蛋白质组学工具应用于儿科临床研究。 Mangum 博士（杜克大学）将与杜克大学和 IJNC 的基因组学研究所共同领导这项合作工作。 6) 培训临床和发育药理学方面的医生和药理学家：核心内容是为期 3 年的儿科药理学奖学金。博士。 Brouwer 和 Lindley（北卡罗来纳大学）将领导该项目。