Development and Application of an Interactive Physiologically Based Pharmacokinetic (iPBPK) Model to Predict Oxytetracycline Tissue Distribution and Withdrawal Intervals in Market-Age Sheep and Goats

Toxicological Sciences - Tập 183 Số 2 - Trang 253-268 - 2021
Mahbubul H. Riad1,2,3, Ronald E. Baynes4, Lisa A. Tell5, Jennifer L. Davis6, Fiona P. Maunsell7, Jim E. Riviere4,3, Zhoumeng Lin1,2,3
1Center for Environmental and Human Toxicology, University of Florida , Florida 32608, USA
2Department of Environmental and Global Health, College of Public Health and Health Professions, University of Florida , Gainesville, Florida 32610, USA
3Institute of Computational Comparative Medicine (ICCM), Department of Anatomy and Physiology, College of Veterinary Medicine, Kansas State University , Manhattan, Kansas 66506, USA
4Center for Chemical Toxicology Research and Pharmacokinetics, Department of Population Health and Pathobiology, College of Veterinary Medicine, North Carolina State University , Raleigh, North Carolina 27606, USA
5Department of Medicine and Epidemiology, School of Veterinary Medicine, University of California–Davis , Davis, California 95616, USA
6Department of Biomedical Sciences and Pathobiology, Virginia–Maryland College of Veterinary Medicine , Blacksburg, Virginia 24060, USA
7Department of Large Animal Clinical Sciences, College of Veterinary Medicine, University of Florida , Gainesville, Florida 32608, USA

Tóm tắt

AbstractOxytetracycline (OTC) is a widely used antibiotic in food-producing animals. Extralabel use of OTC is common and may lead to violative residues in edible tissues. It is important to have a quantitative tool to predict scientifically based withdrawal intervals (WDIs) after extralabel use in food animals to ensure human food safety. This study focuses on developing a physiologically based pharmacokinetic (PBPK) model for OTC in sheep and goats. The model included 7 compartments: plasma, lung, liver, kidneys, muscle, fat, and rest of the body. The model was calibrated with serum and tissue (liver, muscle, kidney, and fat) concentration data following a single intramuscular (IM, 20 mg/kg) and/or intravenous (IV, 10 mg/kg) administration of a long-acting formulation in sheep and goats. The model was evaluated with independent datasets from Food Animal Residue Avoidance Databank (FARAD). Results showed that the model adequately simulated the calibration datasets with an overall estimated coefficient of determination (R2) of 0.95 and 0.92, respectively, for sheep and goat models and had acceptable accuracy for the evaluation datasets. Monte Carlo sampling technique was applied to predict the time needed for drug concentrations in edible tissues to fall below tolerances for the 99th percentiles of the population. The model was converted to a web-based interactive PBPK (iPBPK) interface to facilitate model applications. This iPBPK model provides a useful tool to estimate WDIs for OTC after extralabel use in small ruminants to ensure food safety and serves as a basis for extrapolation to other tetracycline drugs and other food animals.

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Toxicological Sciences

Tập 183 Số 2

253-268

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