Christensen C N
Pediatr Pharmacol (New York). 1980;1(1):15-9.
There is broad agreement that drugs to be used by children should be evaluated in children. Dosage and side effect information, in particular, cannot be reliably extrapolated from data derived from studies in adults. Few problems are encountered in obtaining adequate studies in children of drugs such as antibiotics which have a high potential for use in the pediatric age group. A large number of drugs will have limited use in children. They should be studied in children but the relative scarcity of qualified investigators, the limited patient population available for study, and ethical considerations dictate that the studies will be completed long after studies are completed in adults. These drugs should be allowed on the market before pediatric studies are completed, but there should be a commitment by the sponsor to complete the studies so that all drugs used by children will have adequate directions for use.
人们普遍认为，供儿童使用的药物应该在儿童身上进行评估。尤其是剂量和副作用信息，不能从成人研究数据中可靠地推断出来。在获得足够的针对抗生素等在儿科年龄组有高使用可能性的药物的儿童研究方面，几乎没有遇到问题。大量药物在儿童中的使用将受到限制。它们应该在儿童身上进行研究，但合格研究者相对稀缺、可供研究的患者群体有限以及伦理考量表明，这些研究将在成人研究完成很久之后才能完成。这些药物在儿科研究完成之前应该被允许上市，但申办者应该承诺完成研究，以便所有儿童使用的药物都有足够的使用说明。
