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New Frontiers: Approaches to Understand the Mechanistic Basis of Renal Toxicity.

Nabity MB, Polli JW, Vaidya V, Krolewski A, Glaab WE.

Toxicol Pathol. 2018 Sep 6:192623318798599. doi: 10.1177/0192623318798599. [Epub ahead of print]


Can BSEP Inhibition Testing In Drug Discovery And Development Reduce Liver Injury Risk? - An International Transporter Consortium Perspective.

Kenna JG, Taskar KS, Battista C, Bourdet DL, Brouwer KLR, Brouwer KR, Dai D, Funk C, Hafey MJ, Lai Y, Maher J, Anne Pak Y, Pedersen JM, Polli JW, David Rodrigues A, Watkins PB, Yang K, Yucha RW.

Clin Pharmacol Ther. 2018 Aug 23. doi: 10.1002/cpt.1222. [Epub ahead of print] Review.


Disease-Associated Changes in Drug Transporters May Impact the Pharmacokinetics and/or Toxicity of Drugs: A White Paper From the International Transporter Consortium.

Evers R, Piquette-Miller M, Polli JW, Russel FGM, Sprowl JA, Tohyama K, Ware JA, de Wildt SN, Xie W, Brouwer KLR; International Transporter Consortium.

Clin Pharmacol Ther. 2018 May 14. doi: 10.1002/cpt.1115. [Epub ahead of print] Review.


Hepatobiliary Disposition of Atovaquone: A Case of Mechanistically Unusual Biliary Clearance.

Patel M, Johnson M, Sychterz CJ, Lewis GJ, Watson C, Ellens H, Polli JW, Zamek-Gliszczynski MJ.

J Pharmacol Exp Ther. 2018 Jul;366(1):37-45. doi: 10.1124/jpet.117.247254. Epub 2018 Apr 13.


Toxicokinetics and toxicity of atorvastatin in dogs.

Herron CE, Brueckner CC, Chism JP, Kemp DC, Prescott JS, Smith GA, Melich DH, Oleas N, Polli JW.

Toxicol Appl Pharmacol. 2015 Nov 15;289(1):117-23. doi: 10.1016/j.taap.2015.09.008. Epub 2015 Sep 16.


Drug interaction profile of the HIV integrase inhibitor cabotegravir: assessment from in vitro studies and a clinical investigation with midazolam.

Reese MJ, Bowers GD, Humphreys JE, Gould EP, Ford SL, Webster LO, Polli JW.

Xenobiotica. 2016;46(5):445-56. doi: 10.3109/00498254.2015.1081993. Epub 2015 Sep 4.


Breast cancer resistance protein (ABCG2) in clinical pharmacokinetics and drug interactions: practical recommendations for clinical victim and perpetrator drug-drug interaction study design.

Lee CA, O'Connor MA, Ritchie TK, Galetin A, Cook JA, Ragueneau-Majlessi I, Ellens H, Feng B, Taub ME, Paine MF, Polli JW, Ware JA, Zamek-Gliszczynski MJ.

Drug Metab Dispos. 2015 Apr;43(4):490-509. doi: 10.1124/dmd.114.062174. Epub 2015 Jan 13. Review.


Understanding the transport properties of metabolites: case studies and considerations for drug development.

Zamek-Gliszczynski MJ, Chu X, Polli JW, Paine MF, Galetin A.

Drug Metab Dispos. 2014 Apr;42(4):650-64. doi: 10.1124/dmd.113.055558. Epub 2013 Dec 17. Review.


First human dose-escalation study with remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2 (SGLT2), in healthy subjects and in subjects with type 2 diabetes mellitus.

Kapur A, O'Connor-Semmes R, Hussey EK, Dobbins RL, Tao W, Hompesch M, Smith GA, Polli JW, James CD Jr, Mikoshiba I, Nunez DJ.

BMC Pharmacol Toxicol. 2013 May 13;14:26. doi: 10.1186/2050-6511-14-26.


Safety, pharmacokinetics and pharmacodynamics of remogliflozin etabonate, a novel SGLT2 inhibitor, and metformin when co-administered in subjects with type 2 diabetes mellitus.

Hussey EK, Kapur A, O'Connor-Semmes R, Tao W, Rafferty B, Polli JW, James CD Jr, Dobbins RL.

BMC Pharmacol Toxicol. 2013 Apr 30;14:25. doi: 10.1186/2050-6511-14-25.


Intracellular drug concentrations and transporters: measurement, modeling, and implications for the liver.

Chu X, Korzekwa K, Elsby R, Fenner K, Galetin A, Lai Y, Matsson P, Moss A, Nagar S, Rosania GR, Bai JP, Polli JW, Sugiyama Y, Brouwer KL; International Transporter Consortium.

Clin Pharmacol Ther. 2013 Jul;94(1):126-41. doi: 10.1038/clpt.2013.78. Epub 2013 Apr 10. Review.


Transporter studies in drug development: experience to date and follow-up on decision trees from the International Transporter Consortium.

Tweedie D, Polli JW, Berglund EG, Huang SM, Zhang L, Poirier A, Chu X, Feng B; International Transporter Consortium.

Clin Pharmacol Ther. 2013 Jul;94(1):113-25. doi: 10.1038/clpt.2013.77. Epub 2013 Apr 10. Review.


Why clinical modulation of efflux transport at the human blood-brain barrier is unlikely: the ITC evidence-based position.

Kalvass JC, Polli JW, Bourdet DL, Feng B, Huang SM, Liu X, Smith QR, Zhang LK, Zamek-Gliszczynski MJ; International Transporter Consortium.

Clin Pharmacol Ther. 2013 Jul;94(1):80-94. doi: 10.1038/clpt.2013.34. Epub 2013 Feb 14. Review.


Conference report: a hitchhiker's guide to outsourcing ADME studies: the inside of outsourcing.

Pritchard JF, Anderson SR, Breuckner C, Premkumar ND, Polli JW.

Bioanalysis. 2013 Feb;5(4):403-5. doi: 10.4155/bio.12.328.


Evaluation of drug interactions of GSK1292263 (a GPR119 agonist) with statins: from in vitro data to clinical study design.

Polli JW, Hussey E, Bush M, Generaux G, Smith G, Collins D, McMullen S, Turner N, Nunez DJ.

Xenobiotica. 2013 Jun;43(6):498-508. doi: 10.3109/00498254.2012.739719. Epub 2012 Dec 21.


Central nervous system disposition and metabolism of Fosdevirine (GSK2248761), a non-nucleoside reverse transcriptase inhibitor: an LC-MS and Matrix-assisted laser desorption/ionization imaging MS investigation into central nervous system toxicity.

Castellino S, Groseclose MR, Sigafoos J, Wagner D, de Serres M, Polli JW, Romach E, Myer J, Hamilton B.

Chem Res Toxicol. 2013 Feb 18;26(2):241-51. doi: 10.1021/tx3004196. Epub 2012 Dec 20.


In vitro investigations into the roles of drug transporters and metabolizing enzymes in the disposition and drug interactions of dolutegravir, a HIV integrase inhibitor.

Reese MJ, Savina PM, Generaux GT, Tracey H, Humphreys JE, Kanaoka E, Webster LO, Harmon KA, Clarke JD, Polli JW.

Drug Metab Dispos. 2013 Feb;41(2):353-61. doi: 10.1124/dmd.112.048918. Epub 2012 Nov 6.


Assessment of the drug interaction risk for remogliflozin etabonate, a sodium-dependent glucose cotransporter-2 inhibitor: evidence from in vitro, human mass balance, and ketoconazole interaction studies.

Sigafoos JF, Bowers GD, Castellino S, Culp AG, Wagner DS, Reese MJ, Humphreys JE, Hussey EK, O'Connor Semmes RL, Kapur A, Tao W, Dobbins RL, Polli JW.

Drug Metab Dispos. 2012 Nov;40(11):2090-101. doi: 10.1124/dmd.112.047258. Epub 2012 Jul 30.


Lapatinib distribution in HER2 overexpressing experimental brain metastases of breast cancer.

Taskar KS, Rudraraju V, Mittapalli RK, Samala R, Thorsheim HR, Lockman J, Gril B, Hua E, Palmieri D, Polli JW, Castellino S, Rubin SD, Lockman PR, Steeg PS, Smith QR.

Pharm Res. 2012 Mar;29(3):770-81. doi: 10.1007/s11095-011-0601-8. Epub 2011 Oct 20.


Membrane transporters in drug development.

International Transporter Consortium, Giacomini KM, Huang SM, Tweedie DJ, Benet LZ, Brouwer KL, Chu X, Dahlin A, Evers R, Fischer V, Hillgren KM, Hoffmaster KA, Ishikawa T, Keppler D, Kim RB, Lee CA, Niemi M, Polli JW, Sugiyama Y, Swaan PW, Ware JA, Wright SH, Yee SW, Zamek-Gliszczynski MJ, Zhang L.

Nat Rev Drug Discov. 2010 Mar;9(3):215-36. doi: 10.1038/nrd3028. Review.


Toxicity and toxicokinetics of metformin in rats.

Quaile MP, Melich DH, Jordan HL, Nold JB, Chism JP, Polli JW, Smith GA, Rhodes MC.

Toxicol Appl Pharmacol. 2010 Mar 15;243(3):340-7. doi: 10.1016/j.taap.2009.11.026. Epub 2010 Jan 13.


Use of cassette dosing in sandwich-cultured rat and human hepatocytes to identify drugs that inhibit bile acid transport.

Wolf KK, Vora S, Webster LO, Generaux GT, Polli JW, Brouwer KL.

Toxicol In Vitro. 2010 Feb;24(1):297-309. doi: 10.1016/j.tiv.2009.08.009. Epub 2009 Aug 23.


Oral sulfasalazine as a clinical BCRP probe substrate: pharmacokinetic effects of genetic variation (C421A) and pantoprazole coadministration.

Adkison KK, Vaidya SS, Lee DY, Koo SH, Li L, Mehta AA, Gross AS, Polli JW, Humphreys JE, Lou Y, Lee EJ.

J Pharm Sci. 2010 Feb;99(2):1046-62. doi: 10.1002/jps.21860.


Biopharmaceutics classification system: validation and learnings of an in vitro permeability assay.

Thiel-Demby VE, Humphreys JE, St John Williams LA, Ellens HM, Shah N, Ayrton AD, Polli JW.

Mol Pharm. 2009 Jan-Feb;6(1):11-8. doi: 10.1021/mp800122b.


PhRMA white paper on ADME pharmacogenomics.

Williams JA, Andersson T, Andersson TB, Blanchard R, Behm MO, Cohen N, Edeki T, Franc M, Hillgren KM, Johnson KJ, Katz DA, Milton MN, Murray BP, Polli JW, Ricci D, Shipley LA, Vangala S, Wrighton SA.

J Clin Pharmacol. 2008 Jul;48(7):849-89. doi: 10.1177/0091270008319329. Epub 2008 Jun 4. Review.


The ABCG2 C421A polymorphism does not affect oral nitrofurantoin pharmacokinetics in healthy Chinese male subjects.

Adkison KK, Vaidya SS, Lee DY, Koo SH, Li L, Mehta AA, Gross AS, Polli JW, Lou Y, Lee EJ.

Br J Clin Pharmacol. 2008 Aug;66(2):233-9. doi: 10.1111/j.1365-2125.2008.03184.x. Epub 2008 Apr 22.


The role of efflux and uptake transporters in [N-{3-chloro-4-[(3-fluorobenzyl)oxy]phenyl}-6-[5-({[2-(methylsulfonyl)ethyl]amino}methyl)-2-furyl]-4-quinazolinamine (GW572016, lapatinib) disposition and drug interactions.

Polli JW, Humphreys JE, Harmon KA, Castellino S, O'Mara MJ, Olson KL, John-Williams LS, Koch KM, Serabjit-Singh CJ.

Drug Metab Dispos. 2008 Apr;36(4):695-701. doi: 10.1124/dmd.107.018374. Epub 2008 Jan 23.


Kinetic identification of membrane transporters that assist P-glycoprotein-mediated transport of digoxin and loperamide through a confluent monolayer of MDCKII-hMDR1 cells.

Acharya P, O'Connor MP, Polli JW, Ayrton A, Ellens H, Bentz J.

Drug Metab Dispos. 2008 Feb;36(2):452-60. Epub 2007 Oct 29.


P-Glycoprotein (P-gp) expressed in a confluent monolayer of hMDR1-MDCKII cells has more than one efflux pathway with cooperative binding sites.

Acharya P, Tran TT, Polli JW, Ayrton A, Ellens H, Bentz J.

Biochemistry. 2006 Dec 26;45(51):15505-19. Epub 2006 Nov 30.


In vitro p-glycoprotein inhibition assays for assessment of clinical drug interaction potential of new drug candidates: a recommendation for probe substrates.

Rautio J, Humphreys JE, Webster LO, Balakrishnan A, Keogh JP, Kunta JR, Serabjit-Singh CJ, Polli JW.

Drug Metab Dispos. 2006 May;34(5):786-92. Epub 2006 Feb 2.


Multiple mechanisms are involved in the biliary excretion of acetaminophen sulfate in the rat: role of Mrp2 and Bcrp1.

Zamek-Gliszczynski MJ, Hoffmaster KA, Tian X, Zhao R, Polli JW, Humphreys JE, Webster LO, Bridges AS, Kalvass JC, Brouwer KL.

Drug Metab Dispos. 2005 Aug;33(8):1158-65. Epub 2005 Apr 28.


The elementary mass action rate constants of P-gp transport for a confluent monolayer of MDCKII-hMDR1 cells.

Tran TT, Mittal A, Aldinger T, Polli JW, Ayrton A, Ellens H, Bentz J.

Biophys J. 2005 Jan;88(1):715-38. Epub 2004 Oct 22.


Steady-state brain concentrations of antihistamines in rats: interplay of membrane permeability, P-glycoprotein efflux and plasma protein binding.

Mahar Doan KM, Wring SA, Shampine LJ, Jordan KH, Bishop JP, Kratz J, Yang E, Serabjit-Singh CJ, Adkison KK, Polli JW.

Pharmacology. 2004 Oct;72(2):92-8.


Exact kinetic analysis of passive transport across a polarized confluent MDCK cell monolayer modeled as a single barrier.

Tran TT, Mittal A, Gales T, Maleeff B, Aldinger T, Polli JW, Ayrton A, Ellens H, Bentz J.

J Pharm Sci. 2004 Aug;93(8):2108-23.


The systemic exposure of an N-methyl-D-aspartate receptor antagonist is limited in mice by the P-glycoprotein and breast cancer resistance protein efflux transporters.

Polli JW, Baughman TM, Humphreys JE, Jordan KH, Mote AL, Webster LO, Barnaby RJ, Vitulli G, Bertolotti L, Read KD, Serabjit-Singh CJ.

Drug Metab Dispos. 2004 Jul;32(7):722-6.


Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities.

Polli JE, Yu LX, Cook JA, Amidon GL, Borchardt RT, Burnside BA, Burton PS, Chen ML, Conner DP, Faustino PJ, Hawi AA, Hussain AS, Joshi HN, Kwei G, Lee VH, Lesko LJ, Lipper RA, Loper AE, Nerurkar SG, Polli JW, Sanvordeker DR, Taneja R, Uppoor RS, Vattikonda CS, Wilding I, Zhang G.

J Pharm Sci. 2004 Jun;93(6):1375-81. No abstract available.


Predicting P-glycoprotein substrates by a quantitative structure-activity relationship model.

Gombar VK, Polli JW, Humphreys JE, Wring SA, Serabjit-Singh CS.

J Pharm Sci. 2004 Apr;93(4):957-68.


P-glycoprotein influences the brain concentrations of cetirizine (Zyrtec), a second-generation non-sedating antihistamine.

Polli JW, Baughman TM, Humphreys JE, Jordan KH, Mote AL, Salisbury JA, Tippin TK, Serabjit-Singh CJ.

J Pharm Sci. 2003 Oct;92(10):2082-9.


Midazolam exhibits characteristics of a highly permeable P-glycoprotein substrate.

Tolle-Sander S, Rautio J, Wring S, Polli JW, Polli JE.

Pharm Res. 2003 May;20(5):757-64.


Passive permeability and P-glycoprotein-mediated efflux differentiate central nervous system (CNS) and non-CNS marketed drugs.

Mahar Doan KM, Humphreys JE, Webster LO, Wring SA, Shampine LJ, Serabjit-Singh CJ, Adkison KK, Polli JW.

J Pharmacol Exp Ther. 2002 Dec;303(3):1029-37.


Rational use of in vitro P-glycoprotein assays in drug discovery.

Polli JW, Wring SA, Humphreys JE, Huang L, Morgan JB, Webster LO, Serabjit-Singh CS.

J Pharmacol Exp Ther. 2001 Nov;299(2):620-8.


Influence of passive permeability on apparent P-glycoprotein kinetics.

Lentz KA, Polli JW, Wring SA, Humphreys JE, Polli JE.

Pharm Res. 2000 Dec;17(12):1456-60.


Induction of P-glycoprotein and cytochrome P450 3A by HIV protease inhibitors.

Huang L, Wring SA, Woolley JL, Brouwer KR, Serabjit-Singh C, Polli JW.

Drug Metab Dispos. 2001 May;29(5):754-60.


Prospective CYP2D6 genotyping as an exclusion criterion for enrollment of a phase III clinical trial.

Murphy MP, Beaman ME, Clark LS, Cayouette M, Benson L, Morris DM, Polli JW.

Pharmacogenetics. 2000 Oct;10(7):583-90. Erratum in: Pharmacogenetics 2001 Mar;11(2):185.


P-glycoprotein-mediated transport of morphine in brain capillary endothelial cells.

Letrent SP, Polli JW, Humphreys JE, Pollack GM, Brouwer KR, Brouwer KL.

Biochem Pharmacol. 1999 Sep 15;58(6):951-7.


Role of P-glycoprotein on the CNS disposition of amprenavir (141W94), an HIV protease inhibitor.

Polli JW, Jarrett JL, Studenberg SD, Humphreys JE, Dennis SW, Brouwer KR, Woolley JL.

Pharm Res. 1999 Aug;16(8):1206-12.


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