Pediatric Pharmacology Research Unit Network

儿科药理学研究单位网络

• 批准号: 7234853
• 负责人: Jeffrey Scott Barrett
• 金额: $ 50.53万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-01-07 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7234853
• 关键词: Age; Anticoagulation; Arts; Biological Markers; Child; Childhood; Clinical; Correlative Study; Coupled; Critical Illness; Depth; Development; Dexmedetomidine; Disease; Disease susceptibility; Drug Kinetics; Drug Labeling; Genetic Variation; Genotype; Growth; Heparin; Immunocompromised Host; Individual; Industry; Infant; Laboratories; Leadership; Methodology; Molecular; Numbers; Pain management; Patients; Pediatric Hospitals; Personal Satisfaction; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenetics; Pharmacogenomics; Pharmacologic Substance; Pharmacotherapy; Phase I Clinical Trials; Phenotype; Philadelphia; Population; Proteomics; Protocols documentation; Range; Research; Research Infrastructure; Role; Techniques; Toxic effect; Variant; analytical method; base; experience; improved; novel; novel therapeutics; pediatric pharmacology; pharmacokinetic model; programs; response

DESCRIPTION (provided by applicant): The recent advances in our understanding of the molecular basis for a broad range of pediatric diseases, coupled with the legislative changes culminating in the Best Pharmaceuticals for Children Act, has dramatically increased the potential for defining novel therapeutic approaches for a spectrum of childhood diseases. Further, it provides an important opportunity for improving our understanding of how best to utilize medications currently available for children. The Children's Hospital of Philadelphia (CHOP) has the necessary research infrastructure, patient population, and clinical and laboratory expertise to continue its participation and leadership in the Pediatric Pharmacology Research Unit (PPRU) Network. Under the PI leadership of a Board-certified clinical pharmacologist over the past 4 years, the CHOP PPRU experienced impressive growth both in patient accrual to studies and in the development of industry sponsored trials for Network participation. The CHOP PPRU's recruitment of an internationally renowned population pharmacokinetic modeler further increases the depth and strength of this program. The core laboratory has an in depth experience with state-of-the-art analytical techniques allowing for analysis of a broad spectrum of drugs in biologic matrices, each performed according to FDA's Good Laboratory Practices (GLP) specifications. Novel analytical methodologies developed by the CHOP PPRU will allow for ongoing genotype-phenotype correlative studies. The recent establishment of a proteomics core further expands upon these research capabilities. The CHOP PPRU will continue to emphasize clinical pharmacologic trials in the immunocompromised host, the critically ill infant and child, and in pediatric pain management. Two protocols developed for the PPRU Network, "A Pediatric Phase 1 Trial, and Pharmacokinetic, Pharmacogenetic and Pharmacodynamic Study of Dexmedetomidine" and "A Pediatric Population Pharmacokinetic Study of Heparin: Clinical Utility of Exposure and Biomarkers of Anticoagulation" are proposed and highlight CHOP's PPRU scientific focus. Our expertise in drug analytical methods, pharmacokinetic modeling, pharmacogenomics and proteomics, combined with unparalleled pediatric clinical expertise and access to a diverse pediatric population, assure the continued successful participation of the CHOP PPRU in collaborative Network research.

描述（由申请人提供）： 我们对各种儿科疾病的分子基础的理解的最新进展，再加上立法变化最终导致最佳儿童药物法案，这显着提高了定义新型治疗方法的潜力。此外，它为提高我们对如何最好地利用当前可用于儿童使用的药物的理解提供了一个重要的机会。费城儿童医院（CHOP）具有必要的研究基础设施，患者人群以及临床和实验室专业知识，以继续其参与和领导儿科药理学研究部（PPRU）网络。在过去四年中获得董事会认证的临床药物学家的PI领导下，CHOP PPRU在患者对研究的应计和行业赞助的试验进行网络参与方面的增长都令人印象深刻。 CHOP PPRU招募国际知名的人口药代动力学建模者进一步提高了该计划的深度和强度。 核心实验室在最先进的分析技术方面具有深入的经验，可以分析生物矩阵中的广泛药物，每种药物都根据FDA的良好实验室实践（GLP）规范进行。 CHOP PPRU开发的新分析方法将允许进行持续的基因型 - 表型相关研究。最近建立的蛋白质组学核心进一步扩展了这些研究能力。 PPRU将继续强调免疫功能低下的宿主，重症婴儿和儿童以及小儿疼痛管理中的临床药理试验。为PPRU网络开发的两个方案：“小儿1期试验以及右美托咪定的药代动力学，药物遗传学和药效学研究”和“肝素的儿科人群药代动力学研究：暴露和生物标记物的临床效用和抗癌的生物标志物”是抗癌的临床和生物标记的抗癌和强烈chop och Scops Scientix of Scientix of Scienticic and Ppru Scientix of Ppru Scientical ins Ppru Scienticals。我们在药物分析方法，药代动力学建模，药物基因组学和蛋白质组学方面的专业知识，结合了无与伦比的小儿临床专业知识，并获得了各种儿科人群的机会，并确保了CHOP PPRU在协作网络研究中的持续成功参与。