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