Title of article
Impurities in generic pharmaceutical development
Author/Authors
Kovaleski، نويسنده , , John and Kraut، نويسنده , , Bela and Mattiuz، نويسنده , , Annette and Giangiulio، نويسنده , , Michael and Brobst، نويسنده , , Geoffrey and Cagno، نويسنده , , Wayne and Kulkarni، نويسنده , , Prakash and Rauch، نويسنده , , Taylor، نويسنده ,
Issue Information
روزنامه با شماره پیاپی سال 2007
Pages
8
From page
56
To page
63
Abstract
The current practice of characterization and control of impurities in pharmaceuticals is reviewed with emphasis on issues specific to the generic industry. Case studies are discussed to demonstrate that generic pharmaceuticals are therapeutically equivalent to the branded product, even though the color, size, shape, and excipients utilized may not be identical.
Keywords
Degradation , formulation , characterization , specification , Pre-formulation , stability
Journal title
Advanced Drug Delivery Reviews
Serial Year
2007
Journal title
Advanced Drug Delivery Reviews
Record number
1761979
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