publication . Article . 2006

Stability profiles of drug products extended beyond labeled expiration dates

Robbe C. Lyon; Jeb S. Taylor; Donna A. Porter; Hullahalli R. Prasanna; Ajaz S. Hussain;
Open Access
  • Published: 01 Jul 2006
Abstract
The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. This program probably contains the most extensive source of pharmaceutical stability data extant.Thisreportsummarizesextendedstabilityprofilesfor122differentdrugproducts (3005 different lots). The drug products were categorized into five groups based on incidence of initial exte...
Subjects
free text keywords: Pharmaceutical Science, Expiration, Pharmaceutical technology, Expiration date, Drug administration, Operations management, Chemistry, Drug, media_common.quotation_subject, media_common, Stability assessment, Chromatography, Periodic testing, Shelf life
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