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Adv Drug Deliv Rev. 2007 Jan 10;59(1):56-63. Epub 2006 Nov 15.

Impurities in generic pharmaceutical development.

Author information

  • 1Teva Pharmaceuticals USA, 650 Cathill Road, P.O. Box 904, Sellersville, PA 18960, USA. john.kovaleski@tevausa.com

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.

PMID:
17196702
DOI:
10.1016/j.addr.2006.10.009
[PubMed - indexed for MEDLINE]
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