PEDIATRIC PHARMACOLOGY RESEARCH UNIT

儿科药理学研究室

• 批准号: 6873060
• 负责人: GEORGE H MCCRACKEN
• 金额: $ 33.33万
• 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/6873060
• 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）： 为了响应 RFA-HD-03-D01，我们提议在德克萨斯大学西南医学中心 (UTSWMC) 和达拉斯儿童医学中心 (CMC) 设立儿科药理学研究中心 (PPRU)。我们在新生儿、婴儿和较大儿童的临床试验设计和实施方面拥有超过 35 年的经验。 CMC 是德克萨斯州北部一家拥有 350 张床位的主要儿科初级和三级护理机构，患者群体多样化，并拥有全国最繁忙的儿科急诊室和重症监护室之一。其新生儿托儿所位于邻近的帕克兰纪念医院内，是该县最大的新生儿托儿所之一，每年有超过 16,000 名活产婴儿。它配备了住院和门诊监护装置。 CMC药房参与了500多项研究，并拥有全职研究药剂师。我们可以使用专门开发和验证新的药物监测分析方法的分析实验室。我们拥有美国历史最悠久、规模最大的儿科传染病奖学金培训项目之一，并参与药学博士住院医师培训。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理学研究，包括药代动力学、药效学、安全性和功效研究。 单位具体情况如下： 1- 成为 PPRU 中心，进行儿科药代动力学、药物生物利用度、配方、安全性、耐受性和有效性试验 2- 收集儿科药物特定年龄标签的数据 3- 在儿科药理学新领域进行研究 4- 应用药物基因组学更好地了解和治疗婴儿和儿童疾病 5- 开发和应用蛋白质组学进行发病机制和儿科药理学研究 6- 将 PPRU 开发为教学和培训药学学生、药学博士住院医师和研究员、儿科亚专业研究员和副儿科药理学家的资源 我们将积极与网络合作，提供可由网络中的中心执行的协议并参与其他单位提出的试验。