North Carolina Collaborative PPRU Network

描述（由申请人提供）： 北卡罗来纳州儿科药理学合作研究单位（NCC-PPRU）将由杜克大学和北卡罗来纳州大学（University Of North Carolina，简称北卡罗来纳）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。教师领导将确保两个机构的基础设施的整合。 NCC-PPRU计划将有6个具体目标： 1)进行新药及许可药物的生物利用度、代谢药代动力学、药效学、安全性及有效性的研究。这些研究由Pollack博士领导，将依赖于药学定量色谱和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批准新的和以前许可的药物的儿科适应症。由PPRU网络开发的合作研究的患者招募将由McKinney博士（杜克）领导，并将从杜克大学儿科临床研究计划的成熟跨学科临床试验组发展而来。麦金尼博士将在本杰明（杜克）和雷奇-博加特（Retsch-Bogart）博士的协助下，整合两家机构的临床部门。舒尔曼博士（杜克）和Retsch-Bogart将领导协调综合临床研究中心资源的工作。本杰明博士和李博士（杜克）将整合杜克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（高级顾问，辛辛那提）将促进与治疗学教育和研究中心的伙伴关系，以实现这一目标。 4)进行药物代谢酵素、转运蛋白及受体发育特性之研究。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)在儿科临床研究中应用药物基因组学和蛋白质组学工具。Mangum博士（杜克）将与杜克和IJNC的基因组学研究所一起领导这项合作。 6)培养临床和发展药理学方面的医生和药理学家：中心将是一个为期3年的儿科药理学奖学金。Brouwer和Lindley博士将领导这个项目。

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.