Polymorphism in generic drug product development

被引：84

作者：

Snider, DA ^{[1
]}

Addicks, W ^{[1
]}

Owens, W ^{[1
]}

机构：

[1] Mylan Pharmaceut Inc, Morgantown, WV 26504 USA

来源：

ADVANCED DRUG DELIVERY REVIEWS | 2004年 / 56卷 / 03期

关键词：

polymorphism; generic; DSC; dissolution; compressibility; formulation; bioequivalence;

D O I：

10.1016/j.addr.2003.10.010

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The affect of polymorphism in the development of generic drug products is discussed. The desired polymorphic form is used based upon the ability to manufacture a bioequivalent product. The critical issues are control of the polymorphic form of the drug substance and the dissolution behavior of the drug product. (C) 2003 Published by Elsevier B.V.

引用

收藏

页码：391 / 395

页数：5

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