PubMed · 17196702
Impurities in generic pharmaceutical development.
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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John Kovaleski, Bela Kraut, Annette Mattiuz, Michael Giangiulio, Geoffrey Brobst, Wayne Cagno, Prakash Kulkarni, Taylor Rauch. 2006-11-15. Impurities in generic pharmaceutical development.. https://doi.org/10.1016/j.addr.2006.10.009
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