Non-invasive Assessment of Opiate Analgesia in Children with Sickle Cell Disease

描述（由申请人提供）：我们正在提交一份申请儿科药理学理学硕士学位的提案，以支持Yewande J. Johnson， M.D.的培训和职业发展。Johnson博士是一名初级儿科麻醉师，她希望将她的培训和职业生涯投入到儿科临床药理学领域。她已经参与了几项儿童镇痛药物的临床试验，并希望培养设计、执行和解释儿科药物试验的技能。此外，Johnson博士想了解与儿科药品标签有关的监管问题。重要的机构和部门的承诺，包括财政支持，已经提供了建立一个一流的学术儿科临床药理学研究项目在儿童国家医学中心（CNMC）和约翰逊博士将完全嵌入到这个现有的项目。Dr. van den Anker是本提案的私家医生，也是Dr. Johnson的主要导师，他已经获得了大量的nih资助（U10， K24和R01），以保证Dr. Johnson在临床药理学培训期间的资源和专用时间。此外，van den Anker博士是乔治城大学（GU） nigms资助的临床药理学培训补助金（T32）的核心教员之一，这将保证Johnson博士参加这个完全认可的临床药理学培训计划，并允许她参加美国临床药理学委员会的认证考试。此外，她还将参加CNMC/GU的临床研究人员培训计划。她的研究计划是开发镰状细胞病儿童阿片类镇痛的无创评估，这不仅是她培训的一个组成部分，也是根据她的需要量身定制的临床研究课题。她的项目涉及药代动力学，药代动力学/药效学（PK/PD）建模，药物遗传学以及开发可靠的儿童友好的非侵入性药效学评估工具。约翰逊博士的研究将产生一种评估工具，可能对所有年龄段的急性和慢性疼痛的儿科患者都有用，因此代表了一个非常重要和及时的研究课题。除了在药物基因组学/药物遗传学/蛋白质组学和PK/PD建模方面的一般培训外，她还将在儿科药物遗传学和儿科PK-PD建模方面进行为期四周的轮转，以进一步优化她的培训经验。

DESCRIPTION (provided by applicant): We are submitting a proposal for a MSCIDA in Pediatric Pharmacology to support the training and career development of Yewande J. Johnson, M.D. Dr. Johnson is a junior pediatric anesthesiologist who wants to dedicate her training and career to the field of Pediatric Clinical Pharmacology. She has already participated in several clinical trials with analgesic drugs in children and wants to develop skills in designing, executing, and interpreting pediatric drug trials. In addition, Dr. Johnson wants to understand regulatory issues dealing with pediatric labeling of drugs. Significant institutional and departmental commitments, including financial support have been provided to build a premier academic pediatric clinical pharmacology research program at Children's National Medical Center (CNMC) and Dr. Johnson will fully be embedded in this existing program. Dr. van den Anker, the P.I. of this proposal and primary mentor of Dr. Johnson, has received substantial NIH-funding (U10, K24 and R01) to guarantee resources and dedicated time to Dr. Johnson during her clinical pharmacology training period. In addition, Dr. van den Anker is one of the core faculty members of the NIGMS-funded Clinical Pharmacology Training Grant (T32) at Georgetown University (GU) that will guarantee Dr. Johnson with participation in this fully accredited Training Program in Clinical Pharmacology and will allow her to sit for the Certification Exam of the American Board of Clinical Pharmacology. Additionally she also will participate in the training program for clinical researchers available at CNMC/GU. Her research proposal to develop a non-invasive assessment of opiate analgesia in children with sickle cell disease will not only be an integral part of her training but also be a clinical research topic tailored to her needs. Her project involves pharmacokinetics, pharmacokinetic/pharmacodynamic (PK/PD) modeling, pharmacogenetics in addition to the development of a reliable child friendly non-invasive pharmacodynamic assessment tool. Dr. Johnson's research will result in an assessment tool that probably will be useful for pediatric patients of all ages with acute and chronic pain and therefore represent a very important and timely research topic. In addition to her general training in pharmacogenomics/pharmacogenetics/proteomics and PK/PD modeling she will have a 4-week rotation in pediatric pharmacogenetics and a 4-week rotation in pediatric aspects of PK-PD modeling to further optimize her training experience.