仿制药产品开发中的多态性
Polymorphism in generic drug product development.
作者信息
Snider Daniel A, Addicks William, Owens Walter
机构信息
Mylan Pharmaceuticals Incorporated, 781 Chestnut Ridge Road, P.O. Box 4310, Morgantown, WV 26504-4310, USA.
出版信息
Adv Drug Deliv Rev. 2004 Feb 23;56(3):391-5. doi: 10.1016/j.addr.2003.10.010.
PMID:14962588
Abstract
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.
摘要
讨论了多晶型对仿制药产品开发的影响。根据生产生物等效产品的能力使用所需的多晶型形式。关键问题是原料药多晶型形式的控制以及药品的溶出行为。
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