PEDIATRIC CLINICAL RESEARCH PHARMACOLOGY FELLOWSHIP

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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.