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PEDIATRIC PHARMACOLOGY RESEARCH UNIT

儿科药理学研究室

基本信息

批准号：
6627399
负责人：
JACOB V ARANDA
金额：
$ 26.92万
依托单位：
WAYNE STATE UNIVERSITY
依托单位国家：
美国
项目类别：
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/6627399
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

项目摘要

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.

本提案是对RFA编号HD-98-002的回应，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，从中产生有关药物和新生儿和儿科人群的必要数据，以支持FDA批准的药物标签，用于这些人群中越来越多的处方和使用药物。由于缺乏数据，这些药物中的大多数没有标签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部分，重点是早产儿和足月新生儿的药物评价，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，以提高PPRU在最短时间内对大量新生儿进行药物研究的能力。 3)与其他PPRU网络单位和NICHD工作人员合作，以确定在新生儿和儿童中研究的药物，并制定方案和执行这些研究; 4）与各种制药公司签订合同和合作，以赞助并在新生儿和儿童中执行必要的药物试验，从而为赞助商的药物贴上标签; 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，促进各个儿科亚专业的药物研究，以及6）创建并提供创新的、刺激的，为临床药理学研究员、住院医师、药剂师和其他医疗保健提供者的教育和培训提供了富有成效和严格的环境，以获得新生儿和儿科药理学方面的专业知识。该中心拥有庞大的新生儿和儿科患者群体，成熟的临床药理学计划和实验室，新生儿和儿童药物研究的传统，承诺和专业知识，以及强大的药剂师，药理学家，药物学家，重症监护医师和其他亚专业团队，可以领导，参与并为各种治疗类别的许多药物研究做出实质性贡献。

项目成果

期刊论文数量（12）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

PGE2/TXB2 imbalance in neonatal hypoxemic respiratory failure.

PGE2/TXB2 失衡导致新生儿低氧性呼吸衰竭。

DOI：
10.1111/j.1651-2227.2007.00237.x
发表时间：
2007
期刊：
Acta paediatrica (Oslo, Norway : 1992)
影响因子：
0
作者：
Sood,BG;Delaney-Black,V;Glibetic,M;Aranda,JV;Chen,X;Shankaran,S
通讯作者：
Shankaran,S

Randomized placebo-controlled trial of sucrose analgesia on neonatal skin blood flow and pain response during heel lance.

蔗糖镇痛对新生儿皮肤血流和足跟刺痛反应的随机安慰剂对照试验。

DOI：
10.1097/ajp.0000000000000126
发表时间：
2015
期刊：
The Clinical journal of pain
影响因子：
0
作者：
TutagLehr,Victoria;Cortez,Josef;Grever,William;Cepeda,Eugene;Thomas,Ron;Aranda,JacobV
通讯作者：
Aranda,JacobV

Recurring BALB/c mouse lung inflammatory responses to episodic allergen exposure.

DOI：
10.1080/15287394.2013.752323
发表时间：
2013
期刊：
Journal of toxicology and environmental health. Part A
影响因子：
0
作者：
Wilson SJ;Harmer MJ;Lee RL;Rigden HM;Doyon-Reale NM;Forman KM;Gao X;Lieh-Lai MW;Bassett DJ
通讯作者：
Bassett DJ

Pharmacokinetics of buspirone in autistic children.

丁螺环酮在自闭症儿童中的药代动力学。

DOI：
10.1177/0091270006286903
发表时间：
2006
期刊：
Journal of clinical pharmacology
影响因子：
2.9
作者：
Edwards,DavidJ;Chugani,DianeC;Chugani,HarryT;Chehab,Jamal;Malian,Monica;Aranda,JacobV
通讯作者：
Aranda,JacobV

Effects of branching architecture and linker on the activity of hyperbranched polymer-drug conjugates.