Joint DIA/HESI/SAPS Conference on Environmental Assessment of Human Medicines
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Joint DIA/HESI/SAPS Conference on Environmental Assessment of Human Medicines May 22 to 23, Stockholm, Sweden
Accepted Abstracts Human Pharmaceuticalsin US Surface Waters: A Human Health Risk Assessment Frank J. Mastrocco,' Paul D. Anderson? David Cragin,' Vincent J. DAco,' Eileen €! Hayes,' Roger D. Meyerhoff," Nicholas M. Roden' 'Pfizer Inc., New York, New York 'AMEC Earth and Environmental, Westford, Massachusetts 3Merckand Co., Whitehouse Station, New Jersey 4Quantum Management Group, Clifton, NJ 'Bristol-Myers Squibb Company, New Brunswick, New Jersey 6Eli Lilly and Company, Indianapolis, Indiana 'Schering-Plough, Union, New Jersey The detection of low levels of pharmaceuticals in rivers and streams, drinking water, and groundwater has raised questions as to whether these levels may affect human health. This work presents human health risk assessments for 26 active pharmaceutical ingredients (APIs) and/or their metabolites, representing 14 different drug classes, for which environmental monitoring data are available for the United States. Acceptable daily intakes (ADIs) are derived using the considerable data that are available for APls. The resulting ADIs are designed to protect potentially exposed populations, including sensitive subpopulations. The ADls are then used to estimate predicted no effect concentrations (PNECs) for two sources of potential human exposure: drinking water and fish ingestion. The PNECs are compared to measured environmental concentrations (MECs) from the published literature and to maximum predicted environmental concentrations (PECs) generated using the PMTE model. The PhATE model predictions are made under conservative assumptions of low river flow and no depletion (ie, no metabolism, no removal during wastewater or drinking water treatment, and no instream depletion). Ratios of MECs to PNECs are typically very low and consistent with PEC to PNEC ratios. For all 26 compounds, these low ratios indicate that no appreciable human health risk exists from the presence oftrace concentrations of these APIs in surface water and drinking water. ~
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Use of MathematicalModelingto Estimate Mineralization Half-Life: Application to the Veterinary Pharmaceuticals MGA, Spectinomycin,Lincomycin,and Ceftiofur in AerobicallyIncubated Soil W. J. Smolenski, R. C. Greening, B. D. Hummel, S. P.Lesman, J. A. Robinson Pfizer Animal Health, Kalamazoo, Michigan
Veterinary drug residues excreted by livestock typically enter soil systems. If the residue persists, the possibility of environmental effects (ie, bioaccumulation, antibiotic resistance development, toxicity) may increase. Rapid degradation may reduce the likelihood of detrimental environmental effects. Modeling applications typically use half-life (DT,) to predict environmental concentrations. If transformation data are not available, conservative DT, estimates based on mineralization to CO, may be used. Some countries' regulatory authorities use the time to reach 50% mineralization as an estimate of DT,,. When xenobiotics are trans
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