PEDIATRIC PHARMOCOLOGY RESEARCH UNIT

这是一份为克利夫兰儿科药理学研究单位（PPRU）申请继续资助的申请。该单位于1994年9月，即美国国立卫生研究院建立PPRU网络一年后首次获得资助，从那时起，该单位的资助水平仅为该网络中其他单位的一半。尽管存在资金上的偏见，克利夫兰PPRU在过去的3年半里一直是该网络的积极成员，参与了13个网络协议，招募了298名患者。事实上，克利夫兰PPRU已经成为5个已完成或正在进行的网络协议的创新站点；3 .有行业资助和赞助。我们单位还策划、获得赞助并举办了PPRU/欧洲发育生物学学会联合研讨会，题为“治疗孤儿- 30年后”。会议记录将在不久的将来提交出版。为了继续为我们的PPRU寻求资金，我们打算该单位继续与凯斯西储大学儿科药物研究中心保持密切关系。在过去的15年里，该中心参与了几乎所有婴幼儿药物和疫苗的NDA前评估。克利夫兰PPRU不仅准备好了参与当前和未来的网络协议，因为其人员和患者资源，而且，随着这次重新拨款的请求，将为网络带来额外的资产。首先，这一申请将PPRU和儿科临床试验的机构承诺提升到了一个新的水平，在儿科研究副主任的领导下建立了药物研究咨询委员会中心。该委员会将确保所有儿童保健专业人员参与这项临床研究计划。通过与Drusano博士及其团队的合作，我们的单位也大大扩展了药代动力学和建模能力，并通过将我们的PPRU生物统计学/药代动力学核心合并为儿科内新的临床流行病学部门，我们的数据管理和分析能力。最后，通过所包括的研究建议，我们打算建立一个基础，将网络的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在婴儿和儿童中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。所有这些技术将是至关重要的未来儿科治疗和药物标签的婴儿和儿童。

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.