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EPA uncertainty factor workshop

Scientific basis for uncertainty factors used to establish occupational exposure limits for pharmaceutical active ingredients

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Pages 590-613 | Published online: 02 Dec 2008

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Emma Arnesdotter, Vera Rogiers, Tamara Vanhaecke & Mathieu Vinken. (2021) An overview of current practices for regulatory risk assessment with lessons learnt from cosmetics in the European Union. Critical Reviews in Toxicology 51:5, pages 395-417.
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Lisa Wiesner, Maarten Prause & Ester Lovsin Barle. (2018) Topical otic drugs in a multi-purpose manufacturing facility: a guide on determination and application of permitted daily exposure (PDE). Pharmaceutical Development and Technology 23:3, pages 261-264.
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Ester Lovsin Barle, Jean-Claude Bizec, Milica Glogovac, Kamila Gromek & Gian Christian Winkler. (2018) Determination and application of the permitted daily exposure (PDE) for topical ocular drugs in multipurpose manufacturing facilities. Pharmaceutical Development and Technology 23:3, pages 225-230.
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D. A. Dankovic, B. D. Naumann, A. Maier, M. L. Dourson & L. S. Levy. (2015) The Scientific Basis of Uncertainty Factors Used in Setting Occupational Exposure Limits. Journal of Occupational and Environmental Hygiene 12:sup1, pages S55-S68.
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Randa N. Haddadin, Suhair A. Saleh, Manal A. Ayyash & Phillip J. Collier. (2013) Occupational exposure of pharmaceutical workers to drug actives and excipients and their effect on Staphylococcus spp. nasal carriage and antibiotic resistance. International Journal of Occupational and Environmental Health 19:3, pages 207-214.
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A.M.J. Ragas. (2011) Trends and challenges in risk assessment of environmental contaminants. Journal of Integrative Environmental Sciences 8:3, pages 195-218.
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BruceD. Naumann, DavidG. Dolan & EdwardV. Sargent. (2004) Rationale for the Chemical-Specific Adjustment Factors Used to Derive an Occupational Exposure Limit for Timolol Maleate. Human and Ecological Risk Assessment: An International Journal 10:1, pages 99-111.
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A. G. Renwick. (2000) The use of safety or uncertainty factors in the setting of acute reference doses. Food Additives & Contaminants 17:7, pages 627-635.
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DuckH. Suh & MohamedS. Abdel‐Rahman. (1997) Assessing human health risks of chemicals and drugs: An overview. Human and Ecological Risk Assessment: An International Journal 3:4, pages 599-615.
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AbdelrazakM. Kadry, DuckH. Suh & MohamedS. Abdel‐Rahman. (1997) Kinetic and dynamic data of analgesics and NSAIDs drugs reduce 10X uncertainty factors. Human and Ecological Risk Assessment: An International Journal 3:4, pages 567-578.
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BruceD. Naumann, PatriciaA. Weideman, Rakesh Dixit, ScottJ. Grossman, C. Frank Shen & EdwardV. Sargent. (1997) Use of toxicokinetic and toxicodynamic data to reduce uncertainties when setting occupational exposure limits for pharmaceuticals. Human and Ecological Risk Assessment: An International Journal 3:4, pages 555-565.
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Jiayang Kong, Yun Lu, Yunru Ren, Menghao Chen, Gang Liu & Liangliang Shi. (2024) The risk factors and threshold level of subchronic inhalation exposure of reclaimed water. Journal of Environmental Sciences 137, pages 639-650.
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Aishwarya Ray, Patrick Forrestal, Chikere Nkwonta, Niharika Rahman, Pilar Byrne, Martin Danaher, Karl Richards, Sean Hogan & Enda Cummins. (2023) Modelling potential human exposure to the urease inhibitor NBPT through the environment-food pathway. Environment International 179, pages 108149.
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Natália Bernardi Videira, Vijayalekshmi Nair, Valérie Paquet & Dean Calhoun. (2023) The changing outlook of psychedelic drugs: The importance of risk assessment and occupational exposure limits. Journal of Applied Toxicology.
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Gunnar Johanson, Tshepo Paulsen Moto & Linda Schenk. (2022) A scoping review of evaluations of and recommendations for default uncertainty factors in human health risk assessment. Journal of Applied Toxicology 43:1, pages 186-194.
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Lisa Wiesner, Selene Araya & Ester Lovsin Barle. (2022) Identifying nonhazardous substances in pharmaceutical manufacturing and setting default health‐based exposure limits (HBELs). Journal of Applied Toxicology 42:9, pages 1443-1457.
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Varun Ahuja & Mohan Krishnappa. (2021) Approaches for setting occupational exposure limits in the pharmaceutical industry. Journal of Applied Toxicology 42:1, pages 154-167.
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Zhen Wang, Yolina Yu Lin Wang, W. Casan Scott, E. Spencer Williams, Michael Ciarlo, Paul DeLeo & Bryan W. Brooks. (2021) Comparative influences of dermal and inhalational routes of exposure on hazards of cleaning product ingredients among mammalian model organisms. Environment International 157, pages 106777.
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Mohammad Charehsaz, Gulcin Tugcu & Ahmet Aydin. (2020) Filling data gap for nicotinic acid, nicotinate esters and nicotinamide for the determination of permitted daily exposure by a category approach. Toxicological Research 37:3, pages 337-344.
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Dennis J. Paustenbach & William D. Cyrs. 2001. Patty's Industrial Hygiene. Patty's Industrial Hygiene 1 51 .
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Zhen Wang, Dan Dinh, W. Casan Scott, E. Spencer Williams, Michael Ciarlo, Paul DeLeo & Bryan W. Brooks. (2019) Critical review and probabilistic health hazard assessment of cleaning product ingredients in all-purpose cleaners, dish care products, and laundry care products. Environment International 125, pages 399-417.
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Camille Jandard, Helena Hemming, Maarten Prause, Claudia Sehner, Markus Schwind, Marc Abromovitz & Ester Lovsin Barle. (2018) Applicability of surface sampling and calculation of surface limits for pharmaceutical drug substances for occupational health purposes. Regulatory Toxicology and Pharmacology 95, pages 434-441.
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Zhen Wang, W. Casan Scott, E. Spencer Williams, Michael Ciarlo, Paul C. DeLeo & Bryan W. Brooks. (2018) Identification of novel uncertainty factors and thresholds of toxicological concern for health hazard and risk assessment: Application to cleaning product ingredients. Environment International 113, pages 357-376.
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E.V. Sargent, B.D. Naumann & C.S. Schwartz. 2018. Comprehensive Toxicology. Comprehensive Toxicology 44 63 .
Anthony J. Streeter & Ellen C. Faria. (2017) Analysis of the variability of the pharmacokinetics of multiple drugs in young adult and elderly subjects and its implications for acceptable daily exposures and cleaning validation limits. International Journal of Hygiene and Environmental Health 220:4, pages 659-672.
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John F. Reichard, M. Andrew Maier, Bruce D. Naumann, Alison M. Pecquet, Thomas Pfister, Reena Sandhu, Edward V. Sargent, Anthony J. Streeter & Patricia A. Weideman. (2016) Toxicokinetic and toxicodynamic considerations when deriving health-based exposure limits for pharmaceuticals. Regulatory Toxicology and Pharmacology 79, pages S67-S78.
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Robert G. Sussman, Anthony R. Schatz, Tracy A. Kimmel, Allan Ader, Bruce D. Naumann & Patricia A. Weideman. (2016) Identifying and assessing highly hazardous drugs within quality risk management programs. Regulatory Toxicology and Pharmacology 79, pages S11-S18.
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Robert G. Sussman, Bruce D. Naumann, Thomas Pfister, Claudia Sehner, Christopher Seaman & Patricia A. Weideman. (2016) A harmonization effort for acceptable daily exposure derivation – Considerations for application of adjustment factors. Regulatory Toxicology and Pharmacology 79, pages S57-S66.
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Ester Lovsin Barle, Gian Christian Winkler, Peter Ulrich, Christopher Perino, Martin Kuster, Alessandro Probst, Silke Thielen & Rudolf Bechter. (2014) Cancer risk of immunosuppressants in manufacturing. Regulatory Toxicology and Pharmacology 70:1, pages 122-124.
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Edward V. Sargent, Ellen Faria, Thomas Pfister & Robert G. Sussman. (2013) Guidance on the establishment of acceptable daily exposure limits (ADE) to support Risk-Based Manufacture of Pharmaceutical Products. Regulatory Toxicology and Pharmacology 65:2, pages 242-250.
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Bruce D. Naumann, Patricia A. Weideman, Ramesh Sarangapani, Shu-Cheih Hu, Rakesh Dixit & Edward V. Sargent. (2009) Investigations of the Use of Bioavailability Data to Adjust Occupational Exposure Limits for Active Pharmaceutical Ingredients. Toxicological Sciences 112:1, pages 196-210.
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