PEDIATRIC PHARMACOLOGY RESEARCH UNITS COORD CTR

NICHD的儿科药理研究单位(PPRU)协调中心为研究所的PPRU网络提供全方位的行政支持，该网络由13个临床站点组成。PPRU临床站点和协调中心通过开展儿科治疗的临床试验和相关翻译研究，促进和促进新药和已上市药物的儿科标签(FDA批准)。目前，在美国，很大比例的婴儿和儿童处方药都是在标签外使用的，因为关于它们的安全性和有效性的数据，以及适合儿童的剂量和配方，缺乏或不充分。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，药物处置和药效的特定年龄变化的影响，或者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努力。协调中心作为参与地点的中心联络点，以促进沟通和反应。

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.