Nahata M C
Ann Pharmacother. 1999 Feb;33(2):247-9. doi: 10.1345/aph.18154.
Lack of pediatric drug formulations for both currently marketed and new drugs continues to be a challenge. Marketing of commercial products, along with pediatric indications, would be the ultimate solution to the lack of pediatric drug formulations. However, until that occurs, funding of research on extemporaneous formulations proposed by scientists should be a high priority. Government, academia, industry, the USPC, and professional associations should collaborate in developing the best policies and an action plan. Infants and children should not be expected to wait for stable extemporaneous formulations of important drugs until an unrealistic goal of having all generic and new drugs available commercially in suitable formulations has been realized.
目前市售药品和新药均缺乏儿科剂型,这仍然是一项挑战。商业产品的上市以及儿科适应症,将是解决儿科药物剂型短缺的最终办法。然而,在实现这一目标之前,资助科学家提出的临时配方研究应成为高度优先事项。政府、学术界、产业界、美国药典委员会和专业协会应合作制定最佳政策和行动计划。在实现所有仿制药和新药都能以合适剂型上市这一不切实际的目标之前,不应期望婴幼儿等待重要药物稳定的临时配方。