North Carolina Collaborative PPRU Network

描述(由申请人提供)： 北卡罗来纳州合作儿科药理学研究单位(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，并增加儿科药代动力学数据的可用性。教师领导层将确保两所学院基础设施的整合。 NCC-PPRU计划将有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的研究。这些研究由波拉克博士(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学和PKIPD实验室的基础设施。 2)与业界建立合作伙伴关系，并收集必要的临床数据，以支持FDA批准新药和以前批准的药物的儿科适应症。由PPRU网络开发的合作研究将由McKinney博士(杜克大学)领导，并将从杜克大学一个成熟的跨学科临床试验小组--儿科临床研究计划--发展起来。麦金尼博士在本杰明博士(杜克大学)和Retsch-Bogart博士(北卡罗来纳大学)的协助下，将整合两家机构的临床部门。舒尔曼博士(杜克大学)和Retsch-Bogart博士将领导协调普通临床研究中心资源的工作。本杰明博士和李(杜克)博士将整合杜克临床研究所内的协调中心资源。 3)发展儿科药理学的新方法和新技术。波拉克博士将领导这些努力；沃尔森博士(辛辛那提高级顾问)将促进与治疗教育和研究中心的伙伴关系，以实现这一目标。 4)研究药物代谢酶、转运体和受体的发育特点。勒克鲁伊斯博士(北卡罗来纳大学)将在药物代谢/运输实验室领导这些工作。 5)药物基因组学和蛋白质组学工具在儿科临床研究中的应用。曼格姆博士(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：中心将是为期3年的儿科药理学奖学金。布劳威尔博士和林德利博士(北卡罗来纳大学)将领导这一项目。

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.