Center for Pediatric Clinical Pharmacology Research

儿科临床药理学研究中心

• 批准号: 7169830
• 负责人: JANICE E SULLIVAN
• 金额: $ 35.52万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 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/7169830
• 关键词: Address; Adolescent; Adult; Age; Basic Science; Biological Markers; Child; Childhood; Clinical; Clinical Data; Clinical Pharmacology; Clinical Research; Clinical Services; Clinical Trials; Development; Diagnosis; Discipline; Disease; Drug Kinetics; Faculty; Health Services Research; Hereditary Disease; Human Development; Institution; Investigation; Label; Laboratories; Laboratory Research; Legal patent; Marketing; Mediator of activation protein; Metabolism; Mission; National Institute of Child Health and Human Development; Newborn Infant; Nurses; Pharmacists; Pharmacodynamics; Pharmacology; Physicians; Physiological; Proteomics; Purpose; Research; Research Infrastructure; Research Personnel; Research Proposals; Resources; Safety; Scientist; Site; Students; Techniques; Toxic effect; Training; Training Programs; Translational Research; United States Food and Drug Administration; United States National Institutes of Health; Universities; absorption; base; design; experience; novel; outcome forecast; pediatric pharmacology; programs; response

DESCRIPTION (provided by applicant): This proposal is submitted in response to RFA HD-O3-O01 to obtain support for the KCPCRU, Louisville, KY, as a sites in the NICHD PPRU Network. Long-term proqrammatic objectives of this proposal are: 1) To expand the active participation of the KCPCRU in multi-centered collaborative Clinical trials for the purpose of generating high-quality scientIfic and clinical data to support age-appropriate labeling of new, currently marketed and off-patent pharmacologic agents in newborns, infants and children 2) To further develop the interactive network of basic and clinical scientists at the University of Louisville dedicated to conducting translational research with a focus on characterizing the effect of human development on biologic targets, key pathogenic mediators and physiologic surrogates of pharmacologic response in children 3) To fulfill the educational mission through the development of a multi-disciplinary training program in which physicians, pharmacists and nurses can gain expertise in Pediatric Clinical Pharmacology. These objectives will be accomplished by the following specific aims: 1) To design and conduct collaborative clinical trials within the PPRU network, NICI-ID, NIH and FDA regarding pharmacokinetics, pharmacodynamics, safety, and efficacy of new, currently marketed and off-patent pharmacologic agents in preterm and term newborns, infants, children and adolescents Priority will be given to PPRU network studies 2) To develop an independent "mini-core" of the U of L Proteomics Laboratory that will serve as a complementary resource for network-sponsored trials and support the application of novel proteomic techniques in pediatric pharmacology studies 3) To apply proteomic techniques to identify, develop, validate andlor extrapolate from adult studies on biomarkers of diagnosis, prognosis, efficacy, toxicity and disease activity 4) To characterize the effects of development, disease and genetics on biologic targets, key pathogenic mediators and physiologic surrogates of pharmacologic response in children using a translational science approach 5) To promote the development of students, residents, fellows and junior faculty in the discipline of Pediatric Clinical Pharmacology by providing a multi-faceted training experience encompassing clinical service, research and didactic lectureship. The investigators and applicant institution are caoable of achieving these aims based upon: 1 )an excellent infrastructure to support the clinical and laboratory research components of our program 2)collective expertise in clinical and basic science aspects of pediatric clinical pharmacology research 3)previous and current research accomplishments including those resulting from collaborative investigations with existing PPRU network sites 4) the presence of a multi-disciplinary collaborative network of basic and clinical research scientists dedicated to the conduct of clinical pharmacology studies in children 5)presentation of 4 novel research proposals that speak directly to the program objectives and that are ideally suited for conduct within the PPRU network.

描述（由申请人提供）： 本建议书是为了响应RFA HD-O3-O 01而提交的，目的是为肯塔基州路易斯维尔的KCPCRU作为NICHD PPRU网络中的一个站点获得支持。本提案的长期方案目标是：1）扩大KCPCRU在多中心合作临床试验中的积极参与，以生成高质量的科学和临床数据，支持新生儿中新的、目前上市的和非专利药物的年龄适当标签，婴儿和儿童2）进一步发展路易斯维尔大学基础和临床科学家的互动网络，致力于开展转化研究，重点是表征效果3）通过制定多学科培训计划，使医生、药剂师和护士能够获得儿科临床药理学方面的专业知识，完成教育使命。这些目标将通过以下具体目标实现：1）在PPRU网络、NICI-ID、NIH和FDA内设计和进行关于新的、目前上市的和非专利药物在早产儿和足月新生儿、婴儿中的药代动力学、药效学、安全性和有效性的合作临床试验，儿童和青少年将优先考虑PPRU网络研究2）开发一个独立的“迷你核心”的L蛋白质组学实验室的U，将作为网络的补充资源-3）应用蛋白质组学技术从成人研究中鉴定、开发、验证和/或外推诊断、预后、疗效、毒性和疾病活动的生物标志物4）表征发育、疾病和遗传学对生物靶点的影响，使用转化科学方法研究儿童中药物反应的关键致病介质和生理替代物5）通过提供包括临床服务、研究和教学讲座在内的多方面培训经验，促进儿科临床药理学学科的学生、住院医生、研究员和初级教师的发展。研究者和申请机构能够实现这些目标，基于：1）支持我们计划的临床和实验室研究部分的优秀基础设施2）儿科临床药理学研究的临床和基础科学方面的集体专业知识3）先前和当前的研究成果，包括与现有PPRU网络站点合作研究的成果4）基础和临床研究科学家的多学科合作网络的存在，致力于在儿童中进行临床药理学研究5）介绍4种直接与计划目标相关的新颖研究提案，非常适合在PPRU网络内进行。