PEDIATRIC CLINICAL RESEARCH PHARMACOLOGY FELLOWSHIP

描述(申请人？S逐字描述)：本报告的主要目标 奖学金是培养一名独立的临床药剂师，他可以 与儿科医生一起有效地从事临床药理学研究 重点是。该奖学金将提供课程作业、培训和研究。 成为临床研究药剂师所需的经验，由 美国临床药理学委员会(ABCP)。授课课程将会 包括应用流行病学、应用生物统计学、临床试验设计、 科学伦理，药品的研究和营销应用， 生物制品和医疗器械、S+基础知识和人口 药代动力学-NONMEM(非线性混合效应模型)。熟练掌握 软件程序SAS、S+、WINNONLIN、TDMS、InNAPHASE、ADAPT II、WINNONMIX、 NONMEM、RIDO和Pharsight将会实现。几个研究项目将是 在奖学金期间完成，将提供以下方面的培训 领域：1)儿科和妇科的标准药代动力学/药效学研究 成人患者；2)药代动力学药物相互作用研究；3)人群 儿童和成人的药代动力学/药效学研究；4)试验 模拟技术；5)儿科临床设计与协调 药理学试验。

DESCRIPTION (the applicant?s description verbatim): The primary goal of this fellowship is to produce an independent clinical pharmacologist who can effectively pursue a career in clinical pharmacology research with a pediatric emphasis. This fellowship will provide the coursework, training, and research experience necessary to become a clinical research pharmacologist certified by the American Board of Clinical Pharmacology (ABCP). Didactic courses will include Applied Epidemiology, Applied Biostatistics, Design of Clinical Trials, Scientific Ethics, Investigational and Marketing Applications for Drugs, Biologics and Medical Devises, S-PLUS Fundamentals, and Population Pharmacokinetics-NONMEM (non-linear mixed-effects modeling). Proficiency in the software programs SAS, S-PLUS, WinNonLin, TDMS, Innaphase, Adapt II, WinNonMix, NONMEM, RIDO and Pharsight will be achieved. Several research projects will be completed during the fellowship that will provide training in the following areas: 1) standard pharmacokinetic/pharmacodynamic studies in pediatric and adult patients; 2) pharmacokinetic drug interaction studies; 3) population pharmacokinetic/ pharmacodynamic studies in children and adults; 4) trial simulation techniques; and 5) design and coordination of pediatric clinical pharmacology trial.