References
Franco C. Billions for biodefense: federal agency biodefense funding, FY2009-FY2010. Biosecurity Bioterrorism. 2009;7:291–309.
HHS Public Health Emergency Medical Countermeasure Enterprise, “Implementation plan for chemical, biological, radiological and nuclear threats,” April 2007; https://www.medicalcountermeasures.gov/BARDA/documents/phemce_implplan_041607final.pdf.
Lyon RC et al. Stability profiles of drug products extended beyond labeled expiration dates. J Pharm Sci. 2006;95:1549–60.
Khan SR et al. United States Food and Drug Administration and Department of Defense Shelf-Life Extension Program of Pharmaceutical Products: progress and promise. J Pharm Sci. 2014;103:1331–6.
Namba T, Hiraki K. PAM (pyridine-2-aldoxime methiodide) therapy for alkyl-phosphate poisoning. J Am Med Assoc. 1958;166:1834–9.
Gunderson CH, Lehmann CR, Sidell FR, Jabbari B. Nerve agents: a review. Neurology. 1992;42:946–50.
Vijayaraghavan R, Jain N, Gautam A, Sharma M, Singh S, Kumar D, et al. Evaluation of the antidotal efficacy of atropine sulphate and pralidoxime chloride given by autoinjectors against nerve agent (Sarin) toxicity. J Med CBR Def. 2007;5:1–12.
Vijayaraghavan R, Bhaskar ASB, Gautam A, Gopalan N, Singh AK, Singh B, et al. A convenient first aid kit for chemical and biological agents and radiation exposure. J Environ Biol. 2012;33:673–81.
Monograph on atropine, international programme on chemical safety evaluation. http://www.inchem.org/documents/antidote/antidote/atropine.htm. Accessed Sept 6 2013.
Schier JG et al. Preparing for chemical terrorism: stability of injectable atropine sulfate. Acad Emerg Med. 2004;11:329–34.
Hasmukh P. Usability of duodote auto injector, FDA Internal Report 2013.
Collombet JM. Nerve agent intoxication: recent neuropathophysiological findings and subsequent impact on medical management prospects. Toxicol Appl Pharm. 2011;255:229–41.
Lamson MJ, Sitki-Green D, Wannarka GL, Mesa M, Andrews P, Pellock J. Pharmacokinetics of diazepam administered intramuscularly by autoinjector versus rectal gel in healthy subjects: a phase I, randomized, open-label, single-dose, crossover, single-center study. Clin Drug Investig. 2011;31:585–97.
Author information
Authors and Affiliations
Corresponding author
Additional information
This article reflects the views of the author and should not be construed to represent FDA’s views or policies.
Rights and permissions
About this article
Cite this article
Khan, S.R., Mohammad, A., Khan, M.A. et al. Critical Importance and Quality Evaluation of Drug Delivery Autoinjectors in the FDA-DOD Shelf Life Extension Program (SLEP). AAPS J 18, 801–803 (2016). https://doi.org/10.1208/s12248-016-9910-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1208/s12248-016-9910-5