摘要
口服磷酸盐结合剂是终末期慢性肾脏病者高磷酸盐血症的重要治疗手段之一。由于其口服不吸收,等效性的研究方法和要求与普通的口服固体制剂不同。作者查阅FDA近年来发布的已上市的常见磷结合制剂的个药指南和体外评价研究文章,对此类制剂的体外等效性评价要求进行了综述,并结合文献数据和审评情况总结了需要关注的问题,以期为此类产品的开发提供有益的参考。
Phosphate binding agents are one of the most effective methods for the treatment of hyperphos- phatemia in patients with chronic kidney disease. Since binding agents are locally-acting gastrointestinal drugs, the design of bioequivalence studies are quite different from normal solid oral dosage forms. The author reviewed the bioequivalence guidance issued by FDA and some published articles for phosphate binding agents and summarized the important considerations for in vitro bioequivalence studies of these products in order to provide some references for the development of phosphate binding agents.
作者
石靖
SHI Jing(Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2018年第21期2588-2592,共5页
Chinese Journal of New Drugs
关键词
磷结合剂
生物等效性
醋酸钙
碳酸镧
司维拉姆
phosphate binding agent
bioequivalence
calcium acetate
lanthanum carbonate
sevelamer