ArticleJournal of pharmaceutical sciences2006
Stability profiles of drug products extended beyond labeled expiration dates.
Article in Journal of pharmaceutical sciences, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Stability and Efficacy of Medicines Beyond Their Expiration Dates: A Systematic Review.Therapeutic innovation & regulatory science · 2026Pooled it
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- Selection of Solubility Enhancement Technologies for S-892216, a Novel COVID-19 Drug Candidate.Pharmaceutics · 2025Article
- The use of expired resuscitation medications for life-threatening first aid conditions: a systematic search and narrative review.Resuscitation plus · 2025Review
- Pharmacological Innovations in Space: Challenges and Future Perspectives.Pharmaceutical research · 2024Review
- Stability of Epinephrine in a Normal Saline Solution.Anesthesia progress · 2024Article
- Symphony of planetary health and prescription medicine for a sustainable future.Indian journal of pharmacology · 2024Article
- Debate-Pro: manufacturers should assess the long-term stability of their antivenoms.Emergency medicine journal : EMJ · 2024Article
- Expiration analysis of the International Space Station formulary for exploration mission planning.NPJ microgravity · 2024Article
- Efficacy of Expired Antibiotics: A Real Debate in the Context of Repeated Drug Shortages.Antibiotics (Basel, Switzerland) · 2024Review
- Assessment of Directional-Hemispherical Reflectance of Tablets with Cefuroxime during Storage under Elevated Temperature and Ultraviolet Radiation.Sensors (Basel, Switzerland) · 2024Article
- Use of Expired Drugs: Patients Benefits versus Industry Interest.JMA journal · 2024Review
- Quality evaluation of selected expired fluoroquinolones medicines obtained from the public hospitals in Jimma zone, Oromia regional state, Ethiopia.Frontiers in medicine · 2024Article
- "Monitoring inflammatory, immune system mediators, and mitochondrial changes related to brain metabolism during space flight".Frontiers in immunology · 2024Review
- The effect of long-term spaceflight on drug potency and the risk of medication failure.NPJ microgravity · 2023Article
- To infinity and beyond: Strategies for fabricating medicines in outer space.International journal of pharmaceutics: X · 2022Article
- A study to investigate the chemical potency, physical stability, and efficacy of analgesic agents over a period of two years post their expiry date.Medical journal, Armed Forces India · 2022Article
- An Overview of Pharmaceutical Production in Thai Hospitals.Hospital pharmacy · 2021Article
- Filling the Gaps in the Pharmacy Workforce in Post-Conflict Areas: Experience from Four Countries in Sub-Saharan Africa.International journal of environmental research and public health · 2021Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
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. This report summarizes extended stability profiles for 122 different drug products (3,005 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.
Indexed as
Identifiers
16721796What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.