Center for Pediatric Clinical Pharmacology Research

儿科临床药理学研究中心

• 批准号: 6727317
• 负责人: JANICE E SULLIVAN
• 金额: $ 35.39万
• 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/6727317
• 关键词: biomarker; chemotherapy; clinical research; clinical trials; cooperative study; developmental genetics; diagnosis; human subject; human therapy evaluation; patient oriented research; pediatric pharmacology; pharmacokinetics; prognosis; proteomics

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）： 该提案是为了响应RFA HD-O3-O01而提交的，以获得NICHD PPRU网络中的KCPCRU，肯塔基州路易斯维尔的KCPCRU。 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致力于进行翻译研究，重点是表征人类发展对儿童药理反应的生物学靶标，关键的病原体介质和生理替代物的影响3）3）通过开发多学科培训计划来实现教育使命，从而在该计划中开发医生，药剂师和护士可以在该计划中获得培养精神病学培训的专业知识。这些目标将通过以下具体目的来实现：1）在PPRU网络，NICI-ID，NIH和FDA中设计和进行协作临床试验，涉及药代动力学，新生和非partent newert in New New，销售和不利的药理药物的新生儿和新生儿，PRETUS，PRETUS，PRETUS，PRETUS，PRETUS，PRETUS，PRETUS，PRETUS，PRETUS，PRETUS，PRETUS的优先级别，新生儿的药物学，安全性，安全性和功效 "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使用转化科学方法对儿童的药理学反应的生物学靶标，关键致病介质和生理替代的归因学5）在儿科临床药理学学科中促进学生，居民，研究员和初级教师的发展，通过为多方面的培训经验提供多种培训的临床服务，研究临床服务，研究，研究，研究，研究，研究和培训。研究人员和申请人机构可以基于以下方面的基础：1）支持我们计划的临床和实验室研究组成部分的良好基础设施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，包括与现有网络和现有网络的协作研究，包括与现有网络的协作和当前的研究成果，以及乘以PPRU网站的协作，并在现有网络中进行协作4）临床研究科学家致力于在儿童中进行临床药理学研究5）介绍了4项新型研究建议，这些建议直接符合计划目标，并且非常适合PPRU网络中的行为。