PEDIATRIC PHARMACOLOGY RESEARCH UNIT

儿科药理学研究室

• 批准号: 6666200
• 负责人: JACOB V ARANDA
• 金额: $ 18万
• 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/6666200
• 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.

这项建议是对RFA编号HD-98-002的回应，该中心将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，从这些中心产生关于药物以及新生儿和儿科人口的必要数据，以支持FDA批准的药物标签，以应对这些人口中开出和使用的越来越多的药物。由于缺乏数据，这些药物大多没有贴上标签，也没有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，并批准在婴儿和儿童身上使用。具体目标是：1)开发儿科药理研究单位网络的新生儿临床药物试验部分，重点是早产儿和足月新生儿的药物评估，包括对这些婴儿目前使用的新分子和旧药物的药效学、生物利用度、配方、动力学、安全性和有效性的研究；2)整合多国新生儿临床药物试验小组，以增强PPRU以最少的时间对大量新生儿进行药物研究的能力。3)与PPRU其他网络单位和NICHD工作人员合作，确定要在新生儿和儿童中研究的药物，并制定方案和进行这些研究；4)与各种制药公司签约并合作，赞助和执行必要的新生儿和儿童药物试验，从而为赞助者的药物贴上标签；5)通过在方案制定、研究绩效和进行这些药物研究的基础设施方面提供援助，促进各儿科次级专科进行药物研究；6)为临床药理学研究员、住院医师、药剂师和其他保健人员的教育和培训创造和提供一个创新、激励、富有成效和严谨的环境，以获得新生儿和儿科药理学方面的专门知识。该中心拥有庞大的新生儿和儿科患者群体，拥有成熟的临床药理学计划和实验室，在新生儿和儿童药物研究方面的传统、承诺和专业知识，以及由药剂师、药理学家、新生儿专家、强化医生和其他子专业人员组成的强大团队，该中心可以领导、参与并对各种治疗类别的许多药物研究做出重大贡献。