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ZENODO; Journal of Pharmaceutical Sciences
Article . 2006 . Peer-reviewed
License: Elsevier TDM
Data sources: ZENODO; Crossref
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Journal of Pharmaceutical Sciences
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Stability profiles of drug products extended beyond labeled expiration dates

Authors: Lyon, Robbe C.; Taylor, Jeb S.; Porter, Donna A.; Prasanna, Hullahalli R.; Hussain, Ajaz S.;

Stability profiles of drug products extended beyond labeled expiration dates

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 extension failures and termination failures (extended lot eventually failed upon re-testing). Based on testing and stability assessment, 88% of the lots were extended at least 1 year beyond their original expiration date for an average extension of 66 months, but the additional stability period was highly variable. The SLEP data supports the assertion that many drug products, if properly stored, can be extended past the expiration date. Due to the lot-to-lot variability, the stability and quality of extended drug products can only be assured by periodic testing and systematic evaluation of each lot. 2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 95:1549-1560, 2006

Subjects by Vocabulary

Microsoft Academic Graph classification: Drug Periodic testing Computer science media_common.quotation_subject Stability (learning theory) Expiration date Stability assessment Food and drug administration Extensive data Operations management Expiration media_common

Keywords

United States Food and Drug Administration, Pharmaceutical Science, United States, United States Government Agencies, Drug Stability, Pharmaceutical Preparations

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popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
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influence
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impulse
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