大环内酯类抗生素申报肠溶制剂立题合理性评述

Perspectives on the evaluation of the rationality in the application of the enteric-coated macrolides antibiotics preparations

针对大环内酯类抗生素申报肠溶制剂时立题依据方面存在的问题,通过比较国内外已上市大环内酯类抗生素肠溶制剂现状,结合新药审评中的思考和实例分析,对该类抗菌药物开发肠溶制剂立题合理性进行评述。

As many issues existed in the application and preparations, we present our insights into the rationality in and offer the essential principles in the evaluation in this the registration of enteric-coated macrolides antibiotics this type of the preparations, provide case discussions, paper.