Modern approaches to quality evaluation of generic drugs for their registration (a review)

被引：0
|
作者：
G. V. Ramenskaya
I. E. Shokhin
机构：
[1] Sechenov Medical Academy,
来源：
Pharmaceutical Chemistry Journal | 2009年 / 43卷
关键词：
generic drug; biopharmaceutical classification system; dissolution test; biowaiver;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
At present the quality of generic drugs for registration in the Russian Federation is checked by studying their bioequivalence. According to FDA and WHO guidelines, some generic drugs can be registered on the basis of only in vitro data (dissolution test) without testing for the bioequivalence in vivo. A biowaiver procedure that is based on a biopharmaceutical classification system is developed for such a simplified registration scheme.
引用
收藏
页码：512 / 515
页数：3
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