PEDIATRIC PHARMACOLOGY RESEARCH UNIT

儿科药理学研究室

• 批准号: 6729572
• 负责人: GEORGE H MCCRACKEN
• 金额: $ 33.76万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-03-15 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6729572
• 关键词: adolescence (12-20); blood chemistry; child (0-11); clinical research; clinical trial phase I; clinical trial phase II; clinical trial phase III; clinical trial phase IV; computational biology; cooperative study; dosage; drug adverse effect; drug interactions; drug metabolism; drug screening /evaluation; drug tolerance; enzyme linked immunosorbent assay; high performance liquid chromatography; human subject; microarray technology; pathologic process; pediatric pharmacology; pharmacogenetics; pharmacokinetics; polymerase chain reaction; proteomics; therapy design /development

DESCRIPTION (provided by applicant): We propose a Pediatric Pharmacology Research Unit (PPRU) at University of Texas Southwestern Medical Center (UTSWMC) and Children's Medical Center of Dallas (CMC) in response to the RFA-HD-03-D01. We have more than 35 years of experience in designing and conducting clinical trials in newborns, infants and older children. CMC is a 350 bed, major pediatric primary and tertiary care facility in North Texas with a diverse patient population, and with one of the busiest pediatric emergency rooms and intensive care units in the country. Its newborn nursery located within the adjacent Parkland Memorial Hospital is one of the largest in the county, with over 16,000 live births annually. It is equiped with in-patient and out-patient monitoring units. The CMC pharmacy has participated in more than 500 research studies and has full time research pharmacists. We have access to an analytical laboratory that specializes in developing and validating new assays for drug monitoring. We have one of the oldest and largest pediatric infectious disease fellowship training programs in the US and also participate in training PharmD residents. Because of these extensive resources and experienced support services, a PPRU at Dallas will help advance the overall pediatric pharmacologic research including pharmacokinetics, pharmacodynamics, safety and efficacy studies. The specific of the unit are the following: 1- To be a PPRU center to conduct pharmcokinetics, drug-bioalvailability, formulation, safety, tolerability and efficiacy trials in pediatrics 2- To gather data for age-specific labeling of drugs in pediatrics 3- To conduct research in novel areas of pediatric pharmacology 4- To apply pharmacogenoflhics to better understand and treat diseases of infants and children 5- To develop and apply proteomics for pathogenesis and pediatric pharmacology studies 6- To develop the PPRU as a resource for teaching and training pharmacy students, PharmD residents and fellows, pediatric sub-specialty fellows., and the Associate Pediatric Pharmacologist We will actively collaborate with the network by providing protocols that could be conducted by centers in the network and by participating in trials brought forward by other units.

描述（由申请人提供）： 我们建议在德克萨斯大学西南医学中心（UTSWMC）和达拉斯儿童医疗中心（CMC）的儿科药理学研究部（PPRU），以响应RFA-HD-03-D01。我们在新生儿，婴儿和大儿童的设计和进行临床试验方面拥有超过35年的经验。 CMC是北德克萨斯州的一张350张病床，主要的儿科初级和三级护理设施，患者人数多样化，并且是该国最繁忙的儿科急诊室和重症监护病房之一。它的新生儿托儿所位于邻近的帕克兰纪念医院内，是该县最大的托儿所之一，每年有超过16,000个活产。它配备了住院和门诊监测单元。 CMC药房已参加了500多项研究，并拥有全职研究药剂师。我们可以使用一个分析实验室，该实验室专门开发和验证用于药物监测的新测定法。我们是美国最古老，最大的小儿传染病研究金培训计划之一，还参加了培训PharmD居民。由于这些广泛的资源和经验丰富的支持服务，达拉斯的PPRU将有助于推进整体儿科药物研究，包括药代动力学，药效学，安全和效力研究。 该单元的特定是以下内容： 1-成为PPRU进行PPRU的中心，用于儿科中的药物，制药，配方，安全性，耐受性和有效性试验 2-收集数据以特定年龄在儿科中的药物标记 3-在小儿药理学的新领域进行研究 4-应用Pharmacogenoflhics以更好地理解和治疗婴儿和儿童的疾病 5-开发和应用蛋白质组学进行发病机理和小儿药理学研究 6-开发PPRU作为教学和培训药房学生，PharmD居民和研究员的资源 我们将通过提供网络中心可以进行的协议来积极与网络合作，并参与其他单位进行的试验。