PEDIATRIC PHARMACOLOGY RESEARCH UNITS COORD CTR

儿科药理学研究单位协调 CTR

• 批准号: 7920485
• 负责人: Rene C. Kozloff
• 金额: $ 96.91万
• 依托单位: KAI RESEARCH, INC
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-01-02 至 2010-01-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7920485
• 关键词: PEDIATRIC; PHARMACOLOGY; RESEARCH; UNITS; COORD

The NICHD's Pediatric Pharmacology Research Units (PPRU) coordinating center provides a full range of administrative support for the Institute's the PPRU network of 13 clinical sites. The PPRU clinical sites and the coordinating center facilitate and promote pediatric ¿labeling¿ (Food and Drug Administration (FDA) approval) of new drugs and drugs already on the market, by conducting clinical trials and related translational research in pediatric therapeutics. Currently, a large percentage of drugs prescribed in the U.S. for infants and children are used ¿off label,¿ because data on their safety and efficacy, and appropriate dosages and formulations for children, are lacking or inadequate. For pediatric labeling, the effects of child development on the pharmacokinetics of drugs, the influence of age-specific changes in drug disposition and pharmacodynamics, or the interplay between disease states in children and their stage of development, must all be investigated. Network consultation and coordinating with the FDA is ongoing and the PPRU also strives to foster cooperative research efforts among academia, industry, and health professionals. The coordinating center serves as a central point of contact for participating sites, to facilitate communication and responsiveness.

NICHD的儿科药理学研究单位（PPRU）协调中心为该研究所的13个临床站点的PPRU网络提供全方位的行政支持。PPRU临床研究中心和协调中心通过开展儿科治疗学的临床试验和相关转化研究，促进和促进新药和已上市药物的儿科标签（食品药品监督管理局（FDA）批准）。目前，美国为婴儿和儿童开的处方药中有很大一部分是标签外使用的，因为有关其安全性和有效性以及儿童适当剂量和配方的数据缺乏或不足。对于儿科标签，必须研究儿童发育对药物药代动力学的影响，药物处置和药效学的年龄特异性变化的影响，或儿童疾病状态与其发育阶段之间的相互作用。与FDA的网络咨询和协调正在进行中，PPRU还努力促进学术界，工业界和卫生专业人员之间的合作研究。协调中心作为参与研究中心的联系中心点，以促进沟通和响应。