PEDIATRIC PHARMACOLOGY RESEARCH UNIT

本提案是为了响应RFA号HD-98-002，即在韦恩州立大学医学院和密歇根儿童医院建立儿科和新生儿临床药理学中心。该中心将与其他网络中心合作，对新生儿、婴儿和儿童的药物进行临床研究，从中产生药物、新生儿和儿科人群的必要数据，以支持fda批准的药物标签，以满足这些人群中越来越多的药物处方和使用。由于缺乏数据，这些药物中的大多数没有标记和批准用于新生儿和儿童。长期目标是让所有药物都贴上标签并被批准用于婴儿和儿童。具体目标是：1)开发儿科药理学研究单位（PPRU）网络的新生儿临床药物试验组成部分，重点关注早产儿和足月新生儿的药物评估，包括目前用于这些婴儿的新分子和旧药物的药效学，生物利用度，配方，动力学，安全性和有效性研究；2)整合跨国新生儿临床药物试验小组，提高PPRU在大量新生儿人群中以最短时间开展药物研究的能力。3)与其他药物预防和药品股网络单位和NICHD工作人员合作，确定新生儿和儿童的研究药物，制定方案并进行这些研究；4)与各制药公司签订合同并进行合作，在新生儿和儿童中进行必要的药物试验，并为赞助商的药物贴上标签；5)通过在方案制定、研究表现和进行这些药物研究的基础设施方面提供援助，促进各种儿科亚专科的药物研究；6)为临床药理学研究员、住院医师、药剂师和其他卫生保健提供者的教育和培训创造和提供一个创新的、激励的、富有成效的和严格的环境，以获得新生儿和儿科药理学的专业知识。该中心拥有庞大的新生儿和儿科患者群体、已建立的临床药理学项目和实验室、新生儿和儿童药物研究的传统、承诺和专业知识，以及一支由药剂师、药理学家、新生儿学家、重症医学家和其他亚专科组成的强大团队，可以领导、参与并实质性地为各种治疗类别的许多药物研究做出贡献。

This proposal is in response to RFA number HD-98-002 to establish a Pediatric and Newborn Center for Clinical Pharmacology at Wayne State University School of Medicine and the Children's Hospital of Michigan. The Center will perform clinical studies on drugs in newborn babies, infants and children, in collaboration with other Network Centers from which requisite data on drugs and the neonatal and pediatric population will be generated to support FDA-approved labeling of drugs for the increasing numbers of drugs being prescribed and used in these populations. Due to the lack of data, the majority of these drugs are not labeled and approved for newborns and children. The long term goal is to have all drugs be labeled and approved for use in babies and children. The specific aims are: 1) to develop a neonatal clinical drug trials component of the Pediatric Pharmacology Research Units (PPRU) Network, focusing on drug evaluation in the preterm and term newborns including studies on pharmacodynamics, bioavailability, formulations, kinetics, safety and efficacy of new molecules and old drugs currently used in these babies; 2) To integrate a multinational neonatal clinical Drug Trials group to enhance the capability of the PPRU to conduct drug studies with the least time on a large neonatal population. 3) To collaborate with other PPRU network units and NICHD staff to identify drugs to be studied in newborns and children and to develop protocols and perform these studies; 4) To contract and collaborate with various pharmaceutical companies to sponsor and to perform requisite drug trials in newborns and children leading to labeling of the sponsor's drugs; 5) to foster drug research by various pediatric subspecialties thru provision of assistance in protocol development, study performance and the infrastructure to conduct these drug studies and 6) to create and provide an innovative, stimulating, productive and rigorous environment for the education and training of clinical pharmacology fellows, residents, pharmacists and other health care givers to attain expertise in neonatal and pediatric pharmacology. With a large newborn and pediatric patient population, an established clinical pharmacology program and laboratories, tradition, commitment and expertise on drug studies in newborns and children, and a strong team of pharmacists, pharmacologists, neonatologists, intensivists and other subspecialties, the Center can lead, participate and substantially contribute to many drug studies in various therapeutic categories.