药学研究2017，Vol.36Issue(5)：305-307,3.DOI:10.13506/j.cnki.jpr.2017.05.016
浅析仿制药一致性评价程序及内容的相关政策
Analysis the policies about the procedures and contents on generic drug quality equivalence assessment
张立颖 1刘旭亮 2张丽宝2
作者信息
- 1. 山东理工大学,山东 淄博 255049
- 2. 山东新华制药股份有限公司,山东 淄博 255086
- 折叠
摘要
Abstract
In order to develop the generic drug quality equivalence assessment,China Food and Drug Administration (CFDA) introduce a lot of policies and technical guidelines.Based on the induction summary,this review discussed the procedures and contents of generic drug quality equivalence assessment to provide reference for evaluation of the consistency.关键词
仿制药/一致性评价/体外溶出曲线Key words
Generic drug/Consistency evaluation/In vitro dissolution curves分类
管理科学引用本文复制引用
张立颖,刘旭亮,张丽宝..浅析仿制药一致性评价程序及内容的相关政策[J].药学研究,2017,36(5):305-307,3.
