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Intrinsic and Extrinsic Pharmacokinetic Variability of Small Molecule Targeted Cancer Therapy.

Reyner E, Lum B, Jing J, Kagedal M, Ware JA, Dickmann LJ.

Clin Transl Sci. 2019 Nov 15. doi: 10.1111/cts.12726. [Epub ahead of print]


Investigation of the absolute bioavailability and human mass balance of navoximod, a novel IDO1 inhibitor.

Ma S, Suchomel J, Yanez E, Yost E, Liang X, Zhu R, Le H, Siebers N, Joas L, Morley R, Royer-Joo S, Pirzkall A, Salphati L, Ware JA, Morrissey KM.

Br J Clin Pharmacol. 2019 Aug;85(8):1751-1760. doi: 10.1111/bcp.13961. Epub 2019 Jun 14.


ITC Commentary on Metformin Clinical Drug-Drug Interaction Study Design That Enables an Efficacy- and Safety-Based Dose Adjustment Decision.

Zamek-Gliszczynski MJ, Chu X, Cook JA, Custodio JM, Galetin A, Giacomini KM, Lee CA, Paine MF, Ray AS, Ware JA, Wittwer MB, Zhang L; International Transporter Consortium.

Clin Pharmacol Ther. 2018 Nov;104(5):781-784. doi: 10.1002/cpt.1082. Epub 2018 May 15.


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 Nov;104(5):900-915. doi: 10.1002/cpt.1115. Epub 2018 Jul 12.


A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Pictilisib in Combination with Erlotinib in Patients with Advanced Solid Tumors.

Leong S, Moss RA, Bowles DW, Ware JA, Zhou J, Spoerke JM, Lackner MR, Shankar G, Schutzman JL, van der Noll R, Voest EE, Schellens JHM.

Oncologist. 2017 Dec;22(12):1491-1499. doi: 10.1634/theoncologist.2017-0090. Epub 2017 Aug 10.


Combining "Bottom-up" and "Top-down" Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics.

Lu T, Fraczkiewicz G, Salphati L, Budha N, Dalziel G, Smelick GS, Morrissey KM, Davis JD, Jin JY, Ware JA.

CPT Pharmacometrics Syst Pharmacol. 2017 Nov;6(11):747-755. doi: 10.1002/psp4.12228. Epub 2017 Oct 17.


Commentary on: "Influence of OATP1B1 Function on the Disposition of Sorafenib-β-D-Glucuronide".

Morrissey KM, Benet LZ, Ware JA.

Clin Transl Sci. 2017 Jul;10(4):240-241. doi: 10.1111/cts.12476. Epub 2017 Jun 29. No abstract available.


Phase I Dose-Escalation Study of Taselisib, an Oral PI3K Inhibitor, in Patients with Advanced Solid Tumors.

Juric D, Krop I, Ramanathan RK, Wilson TR, Ware JA, Sanabria Bohorquez SM, Savage HM, Sampath D, Salphati L, Lin RS, Jin H, Parmar H, Hsu JY, Von Hoff DD, Baselga J.

Cancer Discov. 2017 Jul;7(7):704-715. doi: 10.1158/2159-8290.CD-16-1080. Epub 2017 Mar 22. Erratum in: Cancer Discov. 2018 Nov;8(11):1491.


Pharmacogenomics in the age of personalized medicine.

Dickmann LJ, Ware JA.

Drug Discov Today Technol. 2016 Sep - Dec;21-22:11-16. doi: 10.1016/j.ddtec.2016.11.003. Review.


A multicenter, single-arm, open-label, phase 2 study of apitolisib (GDC-0980) for the treatment of recurrent or persistent endometrial carcinoma (MAGGIE study).

Makker V, Recio FO, Ma L, Matulonis UA, Lauchle JO, Parmar H, Gilbert HN, Ware JA, Zhu R, Lu S, Huw LY, Wang Y, Koeppen H, Spoerke JM, Lackner MR, Aghajanian CA.

Cancer. 2016 Nov 15;122(22):3519-3528. doi: 10.1002/cncr.30286. Epub 2016 Sep 7.


Corrigendum to "Simultaneous determination of itraconazole, hydroxy itraconazole, keto itraconazole and N-desalkyl itraconazole concentration in human plasma using liquid chromatography with tandem mass spectrometry" [J. Chromatogr. B 1020 (2016) 111-119].

Liang X, Van Parys M, Ding X, Zeng N, Bi L, Dorshorst D, McKnight J, Milanowski D, Mao J, Chen Y, Ware JA, Dean B, Hop CECA, Deng Y.

J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Sep 1;1029-1030:239. doi: 10.1016/j.jchromb.2016.06.023. Epub 2016 Jul 16. No abstract available.


Validation and determination of taselisib, a β-sparing phosphoinositide 3-kinase (PI3K) inhibitor, in human plasma by LC-MS/MS.

Ding X, Faber K, Shi Y, McKnight J, Dorshorst D, Ware JA, Dean B.

J Pharm Biomed Anal. 2016 Jul 15;126:117-23. doi: 10.1016/j.jpba.2016.04.030. Epub 2016 Apr 20.


Simultaneous determination of itraconazole, hydroxy itraconazole, keto itraconazole and N-desalkyl itraconazole concentration in human plasma using liquid chromatography with tandem mass spectrometry.

Liang X, Van Parys M, Ding X, Zeng N, Bi L, Dorshort D, McKnight J, Milanowski D, Mao J, Chen Y, Ware JA, Dean B, Hop CE, Deng Y.

J Chromatogr B Analyt Technol Biomed Life Sci. 2016 May 1;1020:111-9. doi: 10.1016/j.jchromb.2016.03.039. Epub 2016 Mar 26. Erratum in: J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Sep 1;1029-1030:239.


Randomized Open-Label Phase II Trial of Apitolisib (GDC-0980), a Novel Inhibitor of the PI3K/Mammalian Target of Rapamycin Pathway, Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma.

Powles T, Lackner MR, Oudard S, Escudier B, Ralph C, Brown JE, Hawkins RE, Castellano D, Rini BI, Staehler MD, Ravaud A, Lin W, O'Keeffe B, Wang Y, Lu S, Spoerke JM, Huw LY, Byrtek M, Zhu R, Ware JA, Motzer RJ.

J Clin Oncol. 2016 May 10;34(14):1660-8. doi: 10.1200/JCO.2015.64.8808. Epub 2016 Mar 7.


Phase I Study of Apitolisib (GDC-0980), Dual Phosphatidylinositol-3-Kinase and Mammalian Target of Rapamycin Kinase Inhibitor, in Patients with Advanced Solid Tumors.

Dolly SO, Wagner AJ, Bendell JC, Kindler HL, Krug LM, Seiwert TY, Zauderer MG, Lolkema MP, Apt D, Yeh RF, Fredrickson JO, Spoerke JM, Koeppen H, Ware JA, Lauchle JO, Burris HA 3rd, de Bono JS.

Clin Cancer Res. 2016 Jun 15;22(12):2874-84. doi: 10.1158/1078-0432.CCR-15-2225. Epub 2016 Jan 19.


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.


First-in-human phase I study of pictilisib (GDC-0941), a potent pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor, in patients with advanced solid tumors.

Sarker D, Ang JE, Baird R, Kristeleit R, Shah K, Moreno V, Clarke PA, Raynaud FI, Levy G, Ware JA, Mazina K, Lin R, Wu J, Fredrickson J, Spoerke JM, Lackner MR, Yan Y, Friedman LS, Kaye SB, Derynck MK, Workman P, de Bono JS.

Clin Cancer Res. 2015 Jan 1;21(1):77-86. doi: 10.1158/1078-0432.CCR-14-0947. Epub 2014 Nov 4.


Breast cancer resistance protein substrate and inhibition evaluation: why, when, and how?

Ware JA, Urquhart BL, Sugiyama Y, Zamek-Gliszczynski MJ.

Drug Metab Dispos. 2014 Dec;42(12):1979-80. doi: 10.1124/dmd.114.060970. No abstract available.


The use of betaine HCl to enhance dasatinib absorption in healthy volunteers with rabeprazole-induced hypochlorhydria.

Yago MR, Frymoyer A, Benet LZ, Smelick GS, Frassetto LA, Ding X, Dean B, Salphati L, Budha N, Jin JY, Dresser MJ, Ware JA.

AAPS J. 2014 Nov;16(6):1358-65. doi: 10.1208/s12248-014-9673-9. Epub 2014 Oct 2.


A supported liquid extraction-LC-MS/MS method for determination of GDC-0980 (Apitolisib), a dual small-molecule inhibitor of class 1A phosphoinositide 3-kinase and mammalian target of rapamycin, in human plasma.

Ding X, Li F, McKnight J, Schmidt C, Strooisma K, Shimizu H, Faber K, Ware JA, Dean B.

J Pharm Biomed Anal. 2014 Nov;100:150-156. doi: 10.1016/j.jpba.2014.08.001. Epub 2014 Aug 10.


Physical chemical drug-drug interactions from drug discovery to registration: new opportunities for the pharmaceutical scientist to impact drug development.

Ware JA, Dalziel G.

Mol Pharm. 2013 Nov 4;10(11):3967-9. doi: 10.1021/mp4005639. No abstract available.


Impact of food and the proton pump inhibitor rabeprazole on the pharmacokinetics of GDC-0941 in healthy volunteers: bench to bedside investigation of pH-dependent solubility.

Ware JA, Dalziel G, Jin JY, Pellett JD, Smelick GS, West DA, Salphati L, Ding X, Sutton R, Fridyland J, Dresser MJ, Morrisson G, Holden SN.

Mol Pharm. 2013 Nov 4;10(11):4074-81. doi: 10.1021/mp4005595. Epub 2013 Oct 24.


Prevalence of acid-reducing agents (ARA) in cancer populations and ARA drug-drug interaction potential for molecular targeted agents in clinical development.

Smelick GS, Heffron TP, Chu L, Dean B, West DA, Duvall SL, Lum BL, Budha N, Holden SN, Benet LZ, Frymoyer A, Dresser MJ, Ware JA.

Mol Pharm. 2013 Nov 4;10(11):4055-62. doi: 10.1021/mp400403s. Epub 2013 Oct 24.


Gastric reacidification with betaine HCl in healthy volunteers with rabeprazole-induced hypochlorhydria.

Yago MR, Frymoyer AR, Smelick GS, Frassetto LA, Budha NR, Dresser MJ, Ware JA, Benet LZ.

Mol Pharm. 2013 Nov 4;10(11):4032-7. doi: 10.1021/mp4003738. Epub 2013 Sep 10.


Pharmacokinetics and absorption of the anticancer agents dasatinib and GDC-0941 under various gastric conditions in dogs--reversing the effect of elevated gastric pH with betaine HCl.

Pang J, Dalziel G, Dean B, Ware JA, Salphati L.

Mol Pharm. 2013 Nov 4;10(11):4024-31. doi: 10.1021/mp400356m. Epub 2013 Sep 11.


Evaluation of metabolism and disposition of GDC-0152 in rats using 14C labeling strategy at two different positions: a novel formation of hippuric acid from 4-phenyl-5-amino-1,2,3-thiadiazole.

Yue Q, Mulder T, Rudewicz PJ, Solon E, Budha N, Ware JA, Lyssikatos J, Hop CE, Wong H, Khojasteh SC.

Drug Metab Dispos. 2013 Feb;41(2):508-17. doi: 10.1124/dmd.112.047019. Epub 2012 Dec 4.


Response to "Drug interactions produced by proton pump inhibitors: not simply a pH effect".

Budha NR, Benet LZ, Ware JA.

Clin Pharmacol Ther. 2013 Feb;93(2):151. doi: 10.1038/clpt.2012.206. Epub 2012 Oct 12. No abstract available.


Dogs are more sensitive to antagonists of inhibitor of apoptosis proteins than rats and humans: a translational toxicokinetic/toxicodynamic analysis.

Wong H, Budha NR, West K, Blackwood E, Ware JA, Yu R, Darbonne WC, Gould SE, Steigerwalt R, Erickson R, Hop CE, LoRusso P, Eckhardt SG, Wagner A, Chan IT, Mamounas M, Flygare JA, Fairbrother WJ.

Toxicol Sci. 2012 Nov;130(1):205-13. doi: 10.1093/toxsci/kfs235. Epub 2012 Jul 28.


Drug absorption interactions between oral targeted anticancer agents and PPIs: is pH-dependent solubility the Achilles heel of targeted therapy?

Budha NR, Frymoyer A, Smelick GS, Jin JY, Yago MR, Dresser MJ, Holden SN, Benet LZ, Ware JA.

Clin Pharmacol Ther. 2012 Aug;92(2):203-13. doi: 10.1038/clpt.2012.73. Epub 2012 Jun 27. Review.


Bridging the gap between preclinical and clinical studies using pharmacokinetic-pharmacodynamic modeling: an analysis of GDC-0973, a MEK inhibitor.

Wong H, Vernillet L, Peterson A, Ware JA, Lee L, Martini JF, Yu P, Li C, Del Rosario G, Choo EF, Hoeflich KP, Shi Y, Aftab BT, Aoyama R, Lam ST, Belvin M, Prescott J.

Clin Cancer Res. 2012 Jun 1;18(11):3090-9. doi: 10.1158/1078-0432.CCR-12-0445. Epub 2012 Apr 10.


A solid phase extraction-liquid chromatographic-tandem mass spectrometry method for determination of concentrations of GDC-0941, a small molecule class I phosphatidylinositide 3-kinase inhibitor, to support clinical development.

Ding X, Morrison G, Dean B, Hop CE, Tobler L, Percey S, Meng M, Reuschel S, West DA, Holden S, Ware JA.

J Pharm Biomed Anal. 2012 Mar 5;61:1-7. doi: 10.1016/j.jpba.2011.11.005. Epub 2011 Nov 25.


Hepatic organic anion transporting polypeptide transporter and thyroid hormone receptor interplay determines cholesterol and glucose homeostasis.

Meyer zu Schwabedissen HE, Ware JA, Finkelstein D, Chaudhry AS, Mansell S, Leon-Ponte M, Strom SC, Zaher H, Schwarz UI, Freeman DJ, Schuetz EG, Tirona RG, Kim RB.

Hepatology. 2011 Aug;54(2):644-54. doi: 10.1002/hep.24391. Epub 2011 Jun 26.


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.


Identification, expression, and functional characterization of full-length and splice variants of murine organic anion transporting polypeptide 1b2.

Meyer Zu Schwabedissen HE, Ware JA, Tirona RG, Kim RB.

Mol Pharm. 2009 Nov-Dec;6(6):1790-7. doi: 10.1021/mp900030w.


Drug-drug interactions mediated through P-glycoprotein: clinical relevance and in vitro-in vivo correlation using digoxin as a probe drug.

Fenner KS, Troutman MD, Kempshall S, Cook JA, Ware JA, Smith DA, Lee CA.

Clin Pharmacol Ther. 2009 Feb;85(2):173-81. doi: 10.1038/clpt.2008.195. Epub 2008 Nov 5.


Curcumin inhibits the activity of ABCG2/BCRP1, a multidrug resistance-linked ABC drug transporter in mice.

Shukla S, Zaher H, Hartz A, Bauer B, Ware JA, Ambudkar SV.

Pharm Res. 2009 Feb;26(2):480-7. doi: 10.1007/s11095-008-9735-8. Epub 2008 Oct 9.


Safety and efficacy of bivalirudin with and without glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes undergoing percutaneous coronary intervention 1-year results from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial.

White HD, Ohman EM, Lincoff AM, Bertrand ME, Colombo A, McLaurin BT, Cox DA, Pocock SJ, Ware JA, Manoukian SV, Lansky AJ, Mehran R, Moses JW, Stone GW.

J Am Coll Cardiol. 2008 Sep 2;52(10):807-14. doi: 10.1016/j.jacc.2008.05.036.


Gamma-glutamyltranspeptidase-mediated degradation of diclofenac-S-acyl-glutathione in vitro and in vivo in rat.

Grillo MP, Hua F, March KL, Benet LZ, Knutson CG, Ware JA.

Chem Res Toxicol. 2008 Oct;21(10):1933-8. doi: 10.1021/tx800073p. Epub 2008 Aug 12.


Targeted disruption of murine organic anion-transporting polypeptide 1b2 (Oatp1b2/Slco1b2) significantly alters disposition of prototypical drug substrates pravastatin and rifampin.

Zaher H, Meyer zu Schwabedissen HE, Tirona RG, Cox ML, Obert LA, Agrawal N, Palandra J, Stock JL, Kim RB, Ware JA.

Mol Pharmacol. 2008 Aug;74(2):320-9. doi: 10.1124/mol.108.046458. Epub 2008 Apr 15.


Breast cancer resistance protein (ABCG2) and drug disposition: intestinal expression, polymorphisms and sulfasalazine as an in vivo probe.

Urquhart BL, Ware JA, Tirona RG, Ho RH, Leake BF, Schwarz UI, Zaher H, Palandra J, Gregor JC, Dresser GK, Kim RB.

Pharmacogenet Genomics. 2008 May;18(5):439-48. doi: 10.1097/FPC.0b013e3282f974dc.


Covalent binding of the nitroso metabolite of sulfamethoxazole is important in induction of drug-specific T-cell responses in vivo.

Cheng L, Stewart BJ, You Q, Petersen DR, Ware JA, Piccotti JR, Kawabata TT, Ju C.

Mol Pharmacol. 2008 Jun;73(6):1769-75. doi: 10.1124/mol.107.043273. Epub 2008 Mar 11.


Pharmacogenetic characterization of sulfasalazine disposition based on NAT2 and ABCG2 (BCRP) gene polymorphisms in humans.

Yamasaki Y, Ieiri I, Kusuhara H, Sasaki T, Kimura M, Tabuchi H, Ando Y, Irie S, Ware J, Nakai Y, Higuchi S, Sugiyama Y.

Clin Pharmacol Ther. 2008 Jul;84(1):95-103. doi: 10.1038/sj.clpt.6100459. Epub 2008 Jan 2.


Development of in vitro methods to predict induction of CYP1A2 and CYP3A4 in humans.

Grover GS, Brayman TG, Voorman RL, Ware JA.

Assay Drug Dev Technol. 2007 Dec;5(6):793-804.


Breast cancer resistance protein (Bcrp/abcg2) is a major determinant of sulfasalazine absorption and elimination in the mouse.

Zaher H, Khan AA, Palandra J, Brayman TG, Yu L, Ware JA.

Mol Pharm. 2006 Jan-Feb;3(1):55-61.


Membrane transporters in drug discovery and development: A new mechanistic ADME era.

Ware JA.

Mol Pharm. 2006 Jan-Feb;3(1):1-2. No abstract available.


Modulation of cell adhesion molecules in various epithelial cell lines after treatment with PP2.

Calcagno AM, Fostel JM, Orchekowski RP, Alston JT, Mattes WB, Siahaan TJ, Ware JA.

Mol Pharm. 2005 May-Jun;2(3):170-84.


Expression and function of ABCB1 and ABCG2 in human placental tissue.

Kolwankar D, Glover DD, Ware JA, Tracy TS.

Drug Metab Dispos. 2005 Apr;33(4):524-9. Epub 2005 Jan 7.


Endothelial cell activation in patients with decompensated heart failure.

Colombo PC, Banchs JE, Celaj S, Talreja A, Lachmann J, Malla S, DuBois NB, Ashton AW, Latif F, Jorde UP, Ware JA, LeJemtel TH.

Circulation. 2005 Jan 4;111(1):58-62. Epub 2004 Dec 20.


Effects of an E-cadherin-derived peptide on the gene expression of Caco-2 cells.

Calcagno AM, Fostel JM, Reyner EL, Sinaga E, Alston JT, Mattes WB, Siahaan TJ, Ware JA.

Pharm Res. 2004 Nov;21(11):2085-94.


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