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Human clearance prediction: shifting the paradigm

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Pages 1039-1048 | Published online: 17 Jul 2009

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Mario Pellegatti. (2013) Dogs and monkeys in preclinical drug development: the challenge of reducing and replacing. Expert Opinion on Drug Metabolism & Toxicology 9:9, pages 1171-1180.
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Peter Ballard, Patrick Brassil, Khanh H. Bui, Hugues Dolgos, Carl Petersson, Anders Tunek & Peter J. H. Webborn. (2012) The right compound in the right assay at the right time: an integrated discovery DMPK strategy. Drug Metabolism Reviews 44:3, pages 224-252.
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Hannah M Jones, Maurice Dickins, Kuresh Youdim, James R Gosset, Neil J Attkins, Tanya L Hay, Ian K Gurrell, Y Raj Logan, Peter J Bungay, Barry C Jones & Iain B Gardner. (2012) Application of PBPK modelling in drug discovery and development at Pfizer. Xenobiotica 42:1, pages 94-106.
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Bo Feng, Jennnifer L LaPerle, George Chang & Manthena VS Varma. (2010) Renal clearance in drug discovery and development: molecular descriptors, drug transporters and disease state. Expert Opinion on Drug Metabolism & Toxicology 6:8, pages 939-952.
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Kenneth H. Grime, Patrick Barton & Dermot F. McGinnity. (2013) Application of In Silico, In Vitro and Preclinical Pharmacokinetic Data for the Effective and Efficient Prediction of Human Pharmacokinetics. Molecular Pharmaceutics 10:4, pages 1191-1206.
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Franco Lombardo, Nigel J. Waters, Upendra A. Argikar, Michelle K. Dennehy, Jenny Zhan, Mithat Gunduz, Shawn P. Harriman, Giuliano Berellini, Ivana Liric Rajlic & R. Scott Obach. (2013) Comprehensive Assessment of Human Pharmacokinetic Prediction Based on In Vivo Animal Pharmacokinetic Data, Part 2: Clearance. The Journal of Clinical Pharmacology 53:2, pages 178-191.
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Jian YinHongxia QiuJing DaiYanhua LuRong ZhaoLi ChenQin Meng. (2013) Prediction of hepatic plasma clearance in vivo from gel-entrapped rat and human hepatocytes. Canadian Journal of Physiology and Pharmacology 91:2, pages 178-186.
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Ken Grime & Stuart W. Paine. (2013) Species Differences in Biliary Clearance and Possible Relevance of Hepatic Uptake and Efflux Transporters Involvement. Drug Metabolism and Disposition 41:2, pages 372-378.
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Sibylle Neuhoff, Lu Gaohua, Howard Burt, Masoud Jamei, Linzhong Li, Geoffrey T. Tucker & Amin Rostami-Hodjegan. 2013. Transporters in Drug Development. Transporters in Drug Development 155 177 .
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Helena Anna Thörn, Erik Sjögren, Paul Alfred Dickinson & Hans Lennernäs. (2012) Binding Processes Determine the Stereoselective Intestinal and Hepatic Extraction of Verapamil in Vivo . Molecular Pharmaceutics 9:11, pages 3034-3045.
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Giuliano Berellini, Nigel J. Waters & Franco Lombardo. (2012) In silico Prediction of Total Human Plasma Clearance. Journal of Chemical Information and Modeling 52:8, pages 2069-2078.
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Manthena V. S. Varma, George Chang, Yurong Lai, Bo Feng, Ayman F. El-Kattan, John Litchfield & Theunis C. Goosen. (2012) Physicochemical Property Space of Hepatobiliary Transport and Computational Models for Predicting Rat Biliary Excretion. Drug Metabolism and Disposition 40:8, pages 1527-1537.
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Kevin Beaumont, Iain Gardner, Kathryn Chapman, Michael Hall & Malcolm Rowland. (2011) Toward an integrated human clearance prediction strategy that minimizes animal use. Journal of Pharmaceutical Sciences 100:10, pages 4518-4535.
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James A. McLure, Donald J. Birkett, David J. Elliot, J. Andrew Williams, Andrew Rowland & John O. Miners. (2011) Application of the Fluorescent Probe 1-Anilinonaphthalene-8-Sulfonate to the Measurement of the Nonspecific Binding of Drugs to Human Liver Microsomes. Drug Metabolism and Disposition 39:9, pages 1711-1717.
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Malcolm RowlandCarl Peck & Geoffrey Tucker. (2011) Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science. Annual Review of Pharmacology and Toxicology 51:1, pages 45-73.
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P Zhao, L Zhang, J A Grillo, Q Liu, J M Bullock, Y J Moon, P Song, S S Brar, R Madabushi, T C Wu, B P Booth, N A Rahman, K S Reynolds, E Gil Berglund, L J Lesko & S-M Huang. (2010) Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review. Clinical Pharmacology & Therapeutics 89:2, pages 259-267.
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Hans V. Westerhoff, Malkhey Verma, Frank J. Bruggeman, Alexey Kolodkin, Maciej Swat, Neil Hayes, Maria Nardelli, Barbara M. Bakker & Jacky L. Snoep. 2011. BetaSys. BetaSys 437 458 .
Michael S. Roberts. (2010) Drug structure–transport relationships. Journal of Pharmacokinetics and Pharmacodynamics 37:6, pages 541-573.
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Takahide Uchimura, Motohiro Kato, Tomohisa Saito & Haruki Kinoshita. (2010) Prediction of human blood-to-plasma drug concentration ratio. Biopharmaceutics & Drug Disposition, pages n/a-n/a.
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