Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2072367 | Advanced Drug Delivery Reviews | 2007 | 8 Pages |
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.
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Authors
John Kovaleski, Bela Kraut, Annette Mattiuz, Michael Giangiulio, Geoffrey Brobst, Wayne Cagno, Prakash Kulkarni, Taylor Rauch,