IMPROVEMENT OF METHODOLOGICAL APPROACHES TO THE STANDARDIZATION OF MEDICINES IN THE PHARMACEUTICAL DOSAGE FORM OF TABLETS

被引：0
|
作者：
Kovaleva, E. L. [1 ]
Bagirova, V. L. [1 ]
Mit'kina, L. I. [1 ]
Matveeva, O. A. [1 ]
Akopova, E. R. [1 ]
Vinogradova, N. A. [1 ]
机构：
[1] Minist Publ Hlth Russian Federat, State Sci Ctr Drug Expertise & Control, Moscow, Russia
来源：
PHARMACEUTICAL CHEMISTRY JOURNAL | 2009年 / 43卷 / 12期
关键词：
tablets; standardization; quality tests; methods of analysis; interpretation of results;
D O I：
10.1007/s11094-010-0378-9
中图分类号：
R914 [药物化学];
学科分类号：
100701 ;
摘要：
The status of "observer" received by Russia in the European Pharmacopoeia Commission provides an opportunity to use materials of Ph. Eur. However, there is no description of finished pharmaceutical dosage forms in Ph. Eur. Therefore, it is necessary to develop national approaches to evaluation of the quality, efficacy, and safety of medicines that conform to the international level of requirements. The article is dedicated to the problem of standardization of medicines in the pharmaceutical dosage form "tablets" that are intended for oral administration.
引用
收藏
页码：668 / 676
页数：9
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