Pediatric Pharmacology Research Unit

儿科药理研究室

基本信息

批准号：
7345486
负责人：
JEFFREY L. BLUMER
金额：
$ 39.77万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
1994
资助国家：
美国
起止时间：
1994-09-29 至 2009-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7345486
关键词：
Academic Medical Centers Adopted Adverse drug effect Age Antihypertensive Agents Area Award Biological Availability Biological Markers Characteristics Chemicals Child Childhood Class Clinical Clinical Data Clinical Pharmacology Clinical Trials Complex Critical Illness Data Dependence Development Drug Formulations Drug Kinetics Drug Labeling Drug effect disorder Drug toxicity Drug usage Effectiveness Enrollment Enzymes Ethotoin Evaluation Funding Genetic Determinism Genetic Polymorphism Goals Head Health Professional Health system Infant Intervention Invasive Label Lead Leadership Legal patent Location Marketing Metabolism Mission National Institute of Child Health and Human Development Numbers Participant Patients Pediatric Hospitals Pharmaceutical Preparations Pharmacodynamics Pharmacogenetics Pharmacologic Substance Pharmacology Phenytoin Population Printing Progress Reports Protocols documentation Reaction Request for Proposals Research Research Design Research Personnel Role Safety Secure Series Site Sleep Disorders Staging Technology Therapeutic Therapeutic Agents Training Programs Translational Research United States Food and Drug Administration United States National Institutes of Health Universities University Hospitals base design developmental genetics drug development hypnotic injured innovation member novel novel strategies novel therapeutics pediatric department pediatric pharmacology pharmacodynamic model programs receptor response symposium translational study zolpidem

Academic Medical Centers Adopted Adverse drug effect Age Antihypertensive Agents Area Award Biological Availability Biological Markers Characteristics Chemicals Child Childhood Class Clinical Clinical Data Clinical Pharmacology Clinical Trials Complex Critical Illness Data Dependence Development Drug Formulations Drug Kinetics Drug Labeling Drug effect disorder Drug toxicity Drug usage Effectiveness Enrollment Enzymes Ethotoin Evaluation Funding Genetic Determinism Genetic Polymorphism Goals Head Health Professional Health system Infant Intervention Invasive Label Lead Leadership Legal patent Location Marketing Metabolism Mission National Institute of Child Health and Human Development Numbers Participant Patients Pediatric Hospitals Pharmaceutical Preparations Pharmacodynamics Pharmacogenetics Pharmacologic Substance Pharmacology Phenytoin Population Printing Progress Reports Protocols documentation Reaction Request for Proposals Research Research Design Research Personnel Role Safety Secure Series Site Sleep Disorders Staging Technology Therapeutic Therapeutic Agents Training Programs Translational Research United States Food and Drug Administration United States National Institutes of Health Universities University Hospitals base design developmental genetics drug development hypnotic injured innovation member novel novel strategies novel therapeutics pediatric department pediatric pharmacology pharmacodynamic model programs receptor response symposium translational study zolpidem

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项目摘要

DESCRIPTION (provided by applicant): This is an application for continuation of funding for the Cleveland Pediatric Pharmacology Research Unit (PPRU). Our unit was first funded in 1994, one year after the establishment of the PPRU and has been funded since then at a level one-half to two thirds that of the other units in the network. Despite this funding bias, Cleveland has been an active member of the Network. During the first four years we participated in 13 network protocols contributing 298 patients. The last five years have seen this trajectory in activity maintained. We have been the lead site on 28 protocols and participated overall in 69 network studies enrolling more than 657 children. We have also completed two major multisite studies designed and coordinated by the Cleveland PPRU that have subsequently been adopted by the drugs' innovators to support SNDA filings. In support of ongoing PPRU activities we have developed two print symposia, one dealing with the evaluation of antihypertensive agents in children and the other dealing with the treatment of sleep disorders in children, designed to set the stage for further clinical trials. Finally we are the lead site on the first PPRU-exclusive multisite R01 application submitted to NIH. Our renewal application both details our accomplishments as a member of the PPRU Network and outlines our plans to expand our research base into several new therapeutic areas. To compliment our demonstrated expertise in pharmacokinetic/ pharmacodynamic modeling we propose a study to evaluate new approaches to study design that should add parsimony to our efforts at pediatric drug development. These approaches will be essential in support of the upcoming PPRU initiatives in response to the Best Pharmaceuticals for Children Act. We will also bring to the network a series of trials in the area of pediatric sleep disorders. We will also present approaches to the integration of pharmacogenetic approaches into the elucidation of novel mechanisms of adverse drug reactions in children. Finally, we will discuss our expanded training program in pediatric pharmacology research.

描述（由申请人提供）：这是为克利夫兰儿科药理学研究部（PPRU）延续资金的申请。我们的部门在PPRU成立一年后，于1994年首次资助，此后已获得资助，该级别的级别是网络中其他单位的三分之二至三分之二。尽管存在这种资金偏见，但克利夫兰还是该网络的活跃成员。在最初的四年中，我们参加了13种贡献298名患者的网络方案。在过去的五年中，维持活动中的这一轨迹。我们一直是28个协议的领先地点，并总体参加了69项网络研究，其中有657多名儿童。我们还完成了两项由Cleveland PPRU设计和协调的主要多站点研究，随后被药物的创新者通过了支持SNDA申请。为了支持正在进行的PPRU活动，我们开发了两次印刷研讨会，一种涉及儿童降压药的评估，另一种处理儿童睡眠障碍的治疗，旨在为进一步的临床试验奠定基础。最后，我们是提交给NIH的第一个PPRU超级列表R01应用程序的领先地点。我们的续签应用程序详细介绍了我们作为PPRU网络成员的成就，并概述了我们将研究基础扩展到几个新的治疗领域的计划。为了补充我们在药代动力学/药效学建模方面具有的专业知识，我们提出了一项研究，以评估研究设计的新方法，以增加我们在儿科药物开发方面的努力。这些方法对于支持即将到来的PPRU计划，以应对最佳儿童制药法案至关重要。我们还将在小儿睡眠障碍领域进行一系列试验。我们还将介绍将药物遗传学方法整合到阐明儿童不良药物反应机制的新机制中的方法。最后，我们将讨论我们在儿科药理学研究方面扩展的培训计划。