Document Detail


Impurities in generic pharmaceutical development.
MedLine Citation:
PMID:  17196702     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
John Kovaleski; Bela Kraut; Annette Mattiuz; Michael Giangiulio; Geoffrey Brobst; Wayne Cagno; Prakash Kulkarni; Taylor Rauch
Publication Detail:
Type:  Journal Article; Review     Date:  2006-11-15
Journal Detail:
Title:  Advanced drug delivery reviews     Volume:  59     ISSN:  0169-409X     ISO Abbreviation:  Adv. Drug Deliv. Rev.     Publication Date:  2007 Jan 
Date Detail:
Created Date:  2007-02-12     Completed Date:  2007-04-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8710523     Medline TA:  Adv Drug Deliv Rev     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  56-63     Citation Subset:  IM    
Affiliation:
Teva Pharmaceuticals USA, 650 Cathill Road, P.O. Box 904, Sellersville, PA 18960, USA. john.kovaleski@tevausa.com
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MeSH Terms
Descriptor/Qualifier:
Drug Contamination*
Drug Stability
Drugs, Generic / standards*
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Drugs, Generic

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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