Pediatric licensing status and the availability of suitable formulations for new medical entities approved in the United States between 1998 and 2002
Pediatric licensing status and the availability of suitable formulations for new medical entities approved in the United States between 1998 and 2002
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DOI：
10.1177/0091270006290509
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发表时间：
2006-09-01
影响因子：
2.9
通讯作者：
Reith, David
中科院分区：
文献类型：
--
作者：
Balakrishnan, Komathi;Grieve, Joanne;Reith, David
在上市批准时和3年后，对美国儿童新医疗实体的可用性进行了检查。1998年至2002年每年在美国批准的新医疗实体使用药物评价和研究中心网站进行识别。对1998年至2005年出版的每一份《医生案头参考》进行了审查，以确定配方和许可信息。1998年至2002年期间获得上市许可的133家新医疗实体中，注册后3年内获得儿童许可的数量从5家（4%）增加到39家（29%）。上市3年后，79种（59%）药物的配方适合儿童，27个（20%）新医疗实体获得许可，并有适合儿童的配方。改善儿童获得药品机会的激励措施应更多地侧重于证明改善了获得药品的机会。
The availability of new medical entities for children in the United States was examined at the time of marketing approval and 3 years later. New medical entities approved in the United States in each of the years 1998 to 2002 were identified using the Center for Drug Evaluation and Research Web site. Each Physicians' Desk Reference published in the years 1998 to 2005 was examined to determine formulations and licensing information. For the 133 new medical entities licensed to be marketed in the period 1998 to 2002, the number licensed for children increased from 5 (4%) to 39 (29%) in the 3 years after registration. After 3 years' marketing, 79 (59%) drugs were in formulations suitable for children, and 27 (20%) of the newmedical entities were licensed and had a suitable formulation for children. Incentives to improve access for children to medicines should focus more on demonstration of improved access.