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