Reference
Center for Drug Evaluation and Research, et al. Guidance for Industry -- Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products. Internet Document : [7 pages], 18 Mar 2014. Available from: URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM389069.pdf
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FDA draft guidelines released on injectable drug vial volume. Reactions Weekly 1494, 3 (2014). https://doi.org/10.1007/s40278-014-9658-6
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DOI: https://doi.org/10.1007/s40278-014-9658-6