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）： 北卡罗来纳州协作儿科药理学研究部（NCC-PPRU）将由杜克大学和北卡罗来纳大学（UNC）的人员组成。 NCC-PPRU将有助于开发带有儿科适应症的新药物，并增加小儿药代动力学数据的可用性。教师领导将确保将两个机构的基础设施整合在一起。 NCC-PPRU计划将具有6个具体目标： 1）进行有关生物利用度，代谢药代动力学，药效学以及新药物和许可药物的安全性和功效的研究。这些研究由Pollack博士（UNC）领导，将依靠UNC药房定量色谱学和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批准新的和以前有执照的药物的儿科指示。 PPRU网络开发的患者应计入的患者将由McKinney博士（DUKE）领导，并将从杜克大学（Duke University） - 儿科临床研究计划的成熟跨学科临床试验小组中发展。麦金尼博士，由博士协助。本杰明（杜克大学）和Retsch-Bogart（UNC）将整合两个机构的临床部门。博士。舒尔曼（杜克大学）和Retsch-Bogart将领导协调一般诊所研究中心资源的努力。博士。本杰明（Benjamin）和李（Li）（杜克大学（Duke））将在杜克临床研究所内将协调中心资源整合在一起。 3）开发新的方法和儿科药理学的创新技术。 Pollack博士将领导这些努力；沃尔森（Walson）博士（辛辛那提（Cincinnati）高级顾问）将促进与治疗和研究中心的合作伙伴关系，以实现这一目标。 4）对药物代谢酶，转运蛋白和受体的发育特征进行研究。 Lecluyse博士（UNC）将领导这些努力在药物代谢/运输实验室中。 5）在小儿临床研究中应用药物基因组和蛋白质组学工具。 Mangum博士（杜克大学）将与杜克和IJNC的基因组学院结合进行这项合作。 6）培训临床和发育药理学的医师和药理学家：核心将是一项为期3年的儿科药理学研究金。博士。 Brouwer和Lindley（UNC）将领导该计划。