title: 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.
authors.affiliation: Teva Pharmaceuticals USA, 650 Cathill Road, P.O. Box 904, Sellersville, PA 18960, USA. john.kovaleski@tevausa.com
authors.forename: John
authors.initials: J
authors.lastname: Kovaleski
authors.forename: Bela
authors.initials: B
authors.lastname: Kraut
authors.forename: Annette
authors.initials: A
authors.lastname: Mattiuz
authors.forename: Michael
authors.initials: M
authors.lastname: Giangiulio
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Brobst
authors.forename: Wayne
authors.initials: W
authors.lastname: Cagno
authors.forename: Prakash
authors.initials: P
authors.lastname: Kulkarni
authors.forename: Taylor
authors.initials: T
authors.lastname: Rauch
mesh_terms: D004340:Drug Contamination; D004355:Drug Stability; D016568:Drugs, Generic / Q000592:standards*; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic