PEDIATRIC PHARMACOLOGY RESEARCH UNIT

儿科药理学研究室

• 批准号: 6490453
• 负责人: JACOB V ARANDA
• 金额: $ 26.17万
• 依托单位: WAYNE STATE UNIVERSITY
• 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 2003-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6490453
• 关键词: age difference; child (0-11); clinical research; clinical trials; cooperative study; dosage; drug adverse effect; drug metabolism; drug screening /evaluation; human subject; human therapy evaluation; infant human (0-1 year); pediatric pharmacology; pediatrics; pharmacokinetics

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.

该建议是对RFA编号HD-98-002的回应，以在韦恩州立大学医学院和密歇根州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，对新生婴儿，婴儿和儿童的药物进行临床研究，从中，将生成有关药物以及新生儿和儿科人群的必要数据，以支持FDA批准的药物标记药物，以供越来越多的药物进行规定并在这些人群中使用。 由于缺乏数据，这些药物中的大多数未被标记和批准新生儿和儿童。 长期目标是将所有药物都被标记和批准用于婴儿和儿童。 具体目的是：1）开发儿科药理学研究单元（PPRU）网络的新生儿临床药物试验组成部分，重点介绍早产和新生儿的药物评估，包括有关药物学，生物利用度，配方，配方，动力学，动力学，动力学，动力学，动力学，旧药物和旧药物和旧药物的安全性的研究； 2）整合跨国新生儿临床药物试验组，以增强PPRU在大量新生儿人群上进行最少时间进行药物研究的能力。 3）与其他PPRU网络单位和NICHD员工合作，以确定要在新生儿和儿童中研究的药物，并制定协议并进行这些研究； 4）与各种制药公司合作并合作，以赞助并在新生儿和儿童中进行必要的药物试验，从而标记赞助商的毒品； 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. 拥有大量的新生儿和儿科患者人群，一项既定的临床药理学计划以及新生儿和儿童药物研究的传统，承诺和专业知识，以及强大的药剂师，药理学家，药理学家，新生儿学家，强化学家和其他亚科群体，该中心可以领导，参与，参与许多药物研究，并为各种药物研究做出了贡献。