PEDIATRIC PHARMOCOLOGY RESEARCH UNIT

儿科药理学研究室

• 批准号: 6138780
• 负责人: JEFFREY L. BLUMER
• 金额: $ 36.82万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-29 至 2003-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6138780
• 关键词: age difference; child (0-11); clinical research; clinical trials; cooperative study; drug adverse effect; drug metabolism; drug screening /evaluation; human subject; human therapy evaluation; pediatric pharmacology; pediatrics; pharmacogenetics; pharmacokinetics

This is an application for continuation of funding for the Cleveland Pediatric Pharmacology Research Unit (PPRU). The unit was first funded in September 1994, one year after the establishment of the PPRU Network by NIH and has been funded since that time at only one half the level of the other units in the Network. Despite this funding bias, the Cleveland PPRU has been an active member of the Network for the past 3 1/2 years, participating in 13 network protocols by enrolling 298 patients. In fact, the Cleveland PPRU has been the innovating site for 5 of the completed or ongoing network protocols; 3 with industry funding and sponsorship. Our unit also planned, obtained sponsorship and held the joint PPRU/European Society of Developmental Biology Symposium entitled "The Therapeutic Orphan - 30 Years Later." The proceedings are due to be submitted for publication in the near future. In seeking continued funding for our PPRU, we intend that the unit continue its intimate relationship with the Center for Drug Research of the Department of Pediatrics at Case Western Reserve University. This Center has been involved in the pre NDA evaluation of virtually every drug and vaccine labeled for infants and children in the past 15 years. The Cleveland PPRU is not only prepared because of its personnel and patient resources to participate in the current and future network protocols, but, with this request for renewed funding will bring additional assets to the Network. First, this application brings a new level of institutional commitment to the PPRU and pediatric clinical trials with the establishment of the Center for Drug Research Advisory Board under the leadership of the Department of Pediatrics Vice-Chair for Research. This Board will ensure participation of all of the child health specialties in this clinical research program. Our unit has also greatly expanded both is pharmacokinetic and modeling capabilities through collaboration with Dr. Drusano and his group, and our data management and analysis capabilities through amalgamation of our PPRU Biostatistics/Pharmacokinetics Core into a new Division of Clinical Epidemiology within the Department of Pediatrics. Lastly, through the research proposals included, we intend to develop a foundation that will further extend the Network capabilities into the areas of molecular pharmcoepidemiology, pharmacokinetic/pharmacodynamic modeling, translational research involving new molecular entity discovery and its clinical application to infants and children as well as the interface of pharmacogenetics with functional genomics. All these technologies will be crucial to the future of pediatric therapeutics and drug labeling for infants and children.

这是一份为克利夫兰儿科药理学研究中心 (PPRU) 继续提供资金的申请。 该单位于 1994 年 9 月首次获得资助，即 NIH 建立 PPRU 网络一年后，自那时起，该单位的资助水平仅为该网络其他单位的一半。 尽管存在资金偏见，克利夫兰 PPRU 在过去 3 1/2 年里一直是该网络的活跃成员，通过招募 298 名患者参与了 13 个网络协议。事实上，克利夫兰 PPRU 一直是 5 个已完成或正在进行的网络协议的创新地点； 3. 获得行业资助和赞助。 我单位还策划、获得赞助并举办了PPRU/欧洲发育生物学会联合研讨会，题为“治疗孤儿——30年后”。 会议记录将于近期提交出版。 在为我们的 PPRU 寻求持续资助时，我们希望该单位继续与凯斯西储大学儿科系药物研究中心保持密切关系。 在过去 15 年里，该中心参与了几乎所有针对婴儿和儿童的药物和疫苗的新药申请前评估。 克利夫兰 PPRU 不仅因其人员和患者资源而做好了参与当前和未来网络协议的准备，而且通过更新资金的请求将为网络带来额外的资产。 首先，随着儿科研究部副主席领导下的药物研究中心顾问委员会的成立，该申请将 PPRU 和儿科临床试验的机构承诺提升到了新的水平。 该委员会将确保所有儿童健康专业参与该临床研究计划。 通过与 Drusano 博士及其团队的合作，我们的部门还大大扩展了药代动力学和建模能力，并通过将 PPRU 生物统计/药代动力学核心合并到儿科内新的临床流行病学部门，大大扩展了我们的数据管理和分析能力。最后，通过所包括的研究提案，我们打算建立一个基础，将网络能力进一步扩展到分子药物流行病学、药代动力学/药效学建模、涉及新分子实体发现及其对婴儿和儿童的临床应用的转化研究以及药物遗传学与功能基因组学的接口等领域。 所有这些技术对于婴儿和儿童儿科治疗和药物标签的未来都至关重要。