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
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
Journal title :
Advanced Drug Delivery Reviews
