PEDIATRIC PHARMACOLOGY RESEARCH UNITS COORD CTR

NICHD的儿科药理学研究单位（PPRU）协调中心为研究所的13个临床站点的PPRU网络提供全方位的行政支持。PPRU临床站点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（FDA批准）。目前，美国开具的婴儿和儿童处方药中有很大一部分是“标签外”使用的，因为缺乏或不充分关于其安全性和有效性的数据，以及适合儿童的剂量和配方。对于儿童标签，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，都必须进行调查。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努力。协调中心作为各参与地点的中心联络点，促进沟通和响应。

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.