摘要
本文主要以FDA,EMA和NMPA相关溶出度指导原则为基础,对仿制药溶出度质量标准建立的目的、内涵、一般过程以及特殊考虑进行了论述。提出目前国内研发单位还需进行更加深入的研究,以保证建立更能反映药物内在质量的溶出度质量标准。
Referring to relevant guidelines of FDA,EMA and NMPA,this paper mainly discusses the purpose,meaning,common procedures and special considerations of establishing dissolution specification.It is pointed out that further in-depth study is still needed in establishing dissolution specification,so that we can truly find a golden criterion that can reflect the intrinsic quality of drugs.
作者
李飞
LI Fei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100038,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第22期2698-2701,共4页
Chinese Journal of New Drugs
关键词
溶出度
质量标准
仿制药
口服固体制剂
dissolution
specification
generic drug
oral solid preparation
