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Research Article

A novel method for deriving thresholds of toxicological concern for vaccine constituents

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Pages 270-275 | Received 01 Feb 2016, Accepted 21 Mar 2016, Published online: 21 Apr 2016

References

  • Benigni R, Bossa C, Jeliazkova N, et al. (2008). The Benigni/Bossa rulebase for mutagenicity and carcinogenicity – a module of Toxtree. European Commission Report. EUR 23241 EN.
  • Cramer GM, Ford RA, Hall RL. (1978). Estimation of toxic hazard – a decision tree approach. Food Cosmet Toxicol 16:255–76.
  • DeSosso JM. (1987). Hazard ranking system issue analysis: toxicity as a ranking factor. U.S. Environmental Protection Agency, 44 p.
  • Dolan DG, Naumann BD, Sargent EV, et al. (2005). Application of threshold of toxicological concern concept to pharmaceutical manufacturing operations. Regul Toxicol Pharmacol 43:1–9.
  • EURL-EVCAM. (2012). Available from: https://eurl-ecvam.jrc.ec.europa.eu/laboratories-research/predictive_toxicology/qsar_tools/toxtree.
  • European Medicines Agency (EMA). (2006). Guideline on the limits of genotoxic impurities. London: EMA. EMEA/CHMP/QWP/251344/2006.
  • Food and Drug Administration (FDA). (1995). Food additives: threshold of regulation of substances used in food-contact articles: final rule. Fed Regist 60:36582–96.
  • International Live Sciences Institute (ILSI). (1999). Threshold of toxicological concern for chemical substances present in the diet. ILSI Europe Threshold of Toxicological Concern Task Force Report.
  • Joint FAO/WHO Expert Committee on Food Additives (JEFCA). (1999). Evaluation of certain food additives and contaminants. Procedure for the safety evaluation of flavouring agents. WHO Technical Report Series 884. Geneva: World Health Organization.
  • Kroes R, Renwick AG, Cheeseman M, et al. (2004). Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem Toxicol 42:65–83.
  • McDonald S. (2002). Science and the regulation of biological products. The Center for Biologics Evaluation and Research. Dept. of Health and Human Services. Available from: http://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/100YearsofBiologicsRegulation/UCM070313.pdf.
  • Müller L, Mauthe R, Riley C, et al. (2006). A rational for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul Toxicol Pharmacol 44:198–211.
  • Munro IC, Ford RA, Kennepohl E, Sprenger JG. (1996). Correlation of structural class with no-observed-effect-levels: a proposal for establishing a threshold of concern. Food Chem Toxicol 34:829–67.
  • Offit PA. (2005). The Cutter incident, 50 years later. N Eng J Med 352:1411–2.

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