FDA对磷结合剂的体外等效性评价要求

FDA recommendation for in vitro bioequivalence studies of phosphate binding agents

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.