Children's Center for Clinical Pharmacology Studies

本提案是对RFA#HD-01-003继续资助儿科药理学的回应 密苏里州堪萨斯城儿童慈悲医院和诊所(CMH)的研究单位作为网站之一 在NICHD PPRU网络内。该股的总体目标是：1)继续和扩大 CMH PPRU在PPRU网络中的协作参与主要目的是生产 将通过创造新的信息和知识来支持为儿童贴标签的数据； 和2)开展发展药理学的基础和翻译研究，这将促进我们的 了解遗传-年龄和疾病相关差异对药物处置和作用的影响 (有利有弊)。具体目标包括：1)合作开展新的和 目前上市的药物优先考虑PPRU网络研究；2)鉴定、整理、 分析和解释来自儿科临床试验的数据，这些数据足以扩大儿科 标记；3)使用分子方法来确定儿童发育、疾病 表达，药物生物转化和药物作用；4)生物信息学，药物基因组学， 代谢组学探索和界定重要药物代谢发育调控的基础 酶和转运体；5)提供独特的教学环境，在这种环境中，儿科医生、医务人员 专科医生、临床药剂师、护士和专职医护人员可获得临床专业知识。 儿科临床药理学的研究与学科。调查人员的能力和 申请机构实现这些目标和具体目标表现为：1)有效 方案组成和管理；2)申请机构内的专门知识和资源；3) I与PPRU网络有关的以往和当前研究成果；4)预计方案 必要的扩展以满足未来五年对儿科临床试验预期增加的需求 并加强将翻译科学纳入药物开发进程；以及5) 提出两个新的研究建议，这两个建议直接与计划目标对话，并且是理想的 适合作为PPRU网络的一部分进行。

This proposal is a sent in response to RFA #HD-01-003 to continue funding of a Pediatric Pharmacology Research Unit at Children's Mercy Hospitals and Clinics (CMH) in Kansas City, Missouri as one of the sites within the NICHD Network of PPRU's. The overall obiectives of the Unit are: 1) to continue and expand collaborative participation of the CMH PPRU in the PPRU Network for the primary purpose of producing data that will support labeling of drugs for children through the creation of new information and knowledge; and 2) To conduct basic and translational research in developmental pharmacology that will advance our understanding of the impact of genetic- age- and disease-related differences in drug disposition and action (both beneficial and adverse). Specific Aims include: 1) The collaborative conduct of studies of new and currently marketed drugs with priority given to PPRU Network studies; 2) The identification, collation, analysis, and interpretation of data from pediatric clinical trials that are sufficient for expansion of pediatric labeling.; 3) Use of molecular approaches to define the "link" between childhood development, disease expressmn, drug biotransformation and drug action; 4) Use of bioinformatics, pharmacogenomics, metabolomics to explore and define the basis of developmental regulation of important drug metabolizing enzymes and transporters; 5) The provision of a unique teaching environment in which pediatricians, medical sub-specialists, clinical pharmacists, nurses and allied health care professionals can gain expertise in clinical investigation and the discipline of pediatric clinical pharmacology. The capability of the investigators and applicant institution to accomplish these objectives and specific aims is demonstrated by: 1) effective programmatic composition and administration; 2) expertise and resources within the applicant institution; 3) iprevious and current research accomplishments related to the PPRU Network; 4) projected programmatic expansion necessary to meet the anticipated increased demands for pediatric clinical trials over the next five years and also, to enhance the integration of translational science into the drug development process; and 5) presentation of two new research proposals which speak directly to the program objectives and are ideally suited for conduct as part of the PPRU Network.