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Items: 1 to 50 of 83

1.

Polyethlyene Glycol 200 can Protect Rats against Drug-Induced Kidney Toxicity through Inhibition of the Renal Organic Anion Transporter 3.

Gu YZ, Chu X, Houle R, Vlasakova K, Koeplinger KA, Bourgeois I, Palyada K, Anderson KD, Brynczka C, Bhatt B, Chen F, Smith R, Amin R, Glaab WE, Lebron J, Cox K, Sistare FD.

Toxicol Sci. 2019 Aug 12. pii: kfz186. doi: 10.1093/toxsci/kfz186. [Epub ahead of print]

PMID:
31406999
2.

Can Galactose Be Converted to Glucose in HepG2 Cells? Improving the in Vitro Mitochondrial Toxicity Assay for the Assessment of Drug Induced Liver Injury.

Xu Q, Liu L, Vu H, Kuhls M, Aslamkhan AG, Liaw A, Yu Y, Kaczor A, Ruth M, Wei C, Imredy J, Lebron J, Pearson K, Gonzalez R, Mitra K, Sistare FD.

Chem Res Toxicol. 2019 Aug 19;32(8):1528-1544. doi: 10.1021/acs.chemrestox.9b00033. Epub 2019 Jul 18.

PMID:
31271030
3.

AhR Activation in Pharmaceutical Development: Applying Liver Gene Expression Biomarker Thresholds to Identify Doses Associated with Tumorigenic Risks in Rats.

Qin C, Aslamkhan AG, Pearson K, Tanis KQ, Podtelezhnikov A, Frank E, Pacchione S, Pippert T, Glaab WE, Sistare FD.

Toxicol Sci. 2019 May 25. pii: kfz125. doi: 10.1093/toxsci/kfz125. [Epub ahead of print]

PMID:
31127949
4.

Use of a Bile Salt Export Pump Knockdown Rat Susceptibility Model to Interrogate Mechanism of Drug-Induced Liver Toxicity.

Li Y, Evers R, Hafey MJ, Cheon K, Duong H, Lynch D, LaFranco-Scheuch L, Pacchione S, Tamburino AM, Tanis KQ, Geddes K, Holder D, Zhang NR, Kang W, Gonzalez RJ, Galijatovic-Idrizbegovic A, Pearson KM, Lebron JA, Glaab WE, Sistare FD.

Toxicol Sci. 2019 Jul 1;170(1):180-198. doi: 10.1093/toxsci/kfz079.

PMID:
30903168
5.

Kidney Safety Assessment: Current Practices in Drug Development.

Troth SP, Simutis F, Friedman GS, Todd S, Sistare FD.

Semin Nephrol. 2019 Mar;39(2):120-131. doi: 10.1016/j.semnephrol.2018.12.002. Review.

PMID:
30827335
6.

A Performance Evaluation of Liver and Skeletal Muscle-Specific miRNAs in Rat Plasma to Detect Drug-Induced Injury.

Bailey WJ, Barnum JE, Erdos Z, LaFranco-Scheuch L, Lane P, Vlasakova K, Sistare FD, Glaab WE.

Toxicol Sci. 2019 Mar 1;168(1):110-125. doi: 10.1093/toxsci/kfy282.

PMID:
30496518
7.

Evaluation of Urinary Renal Biomarkers for Early Prediction of Acute Kidney Injury Following Partial Nephrectomy: A Feasibility Study.

Lane BR, Babitz SK, Vlasakova K, Wong A, Noyes SL, Boshoven W, Grady P, Zimmerman C, Engerman S, Gebben M, Tanen M, Glaab WE, Sistare FD.

Eur Urol Focus. 2018 Nov 10. pii: S2405-4569(18)30318-3. doi: 10.1016/j.euf.2018.10.017. [Epub ahead of print]

PMID:
30425001
8.

Adverse outcome pathway-driven identification of rat liver tumorigens in short-term assays.

Rooney J, Hill T 3rd, Qin C, Sistare FD, Corton JC.

Toxicol Appl Pharmacol. 2018 Oct 1;356:99-113. doi: 10.1016/j.taap.2018.07.023. Epub 2018 Jul 23.

PMID:
30048669
9.

Performance Assessment of New Urinary Translational Safety Biomarkers of Drug-induced Renal Tubular Injury in Tenofovir-treated Cynomolgus Monkeys and Beagle Dogs.

Gu YZ, Vlasakova K, Troth SP, Peiffer RL, Tournade H, Pasello Dos Santos FR, Glaab WE, Sistare FD.

Toxicol Pathol. 2018 Jul;46(5):553-563. doi: 10.1177/0192623318775023. Epub 2018 May 28.

PMID:
29807506
10.

What evidence do we need for biomarker qualification?

Leptak C, Menetski JP, Wagner JA, Aubrecht J, Brady L, Brumfield M, Chin WW, Hoffmann S, Kelloff G, Lavezzari G, Ranganathan R, Sauer JM, Sistare FD, Zabka T, Wholley D.

Sci Transl Med. 2017 Nov 22;9(417). pii: eaal4599. doi: 10.1126/scitranslmed.aal4599. Review.

PMID:
29167393
11.

Vascular Imaging of Matrix Metalloproteinase Activity as an Informative Preclinical Biomarker of Drug-induced Vascular Injury.

Gonzalez RJ, Lin SA, Bednar B, Connolly B, LaFranco-Scheuch L, Mesfin GM, Philip T, Patel S, Johnson T, Sistare FD, Glaab WE.

Toxicol Pathol. 2017 Jul;45(5):633-648. doi: 10.1177/0192623317720731.

PMID:
28830331
12.

Response of Novel Skeletal Muscle Biomarkers in Dogs to Drug-Induced Skeletal Muscle Injury or Sustained Endurance Exercise.

Vlasakova K, Lane P, Michna L, Muniappa N, Sistare FD, Glaab WE.

Toxicol Sci. 2017 Apr 1;156(2):422-427. doi: 10.1093/toxsci/kfw262.

PMID:
28115646
13.

Antibiotic-Induced Elevations of Plasma Bile Acids in Rats Independent of Bsep Inhibition.

Li Y, Hafey MJ, Duong H, Evers R, Cheon K, Holder DJ, Galijatovic-Idrizbegovic A, Sistare FD, Glaab WE.

Toxicol Sci. 2017 May 1;157(1):30-40. doi: 10.1093/toxsci/kfx015.

PMID:
28108666
14.
15.

Role of chronic toxicology studies in revealing new toxicities.

Galijatovic-Idrizbegovic A, Miller JE, Cornell WD, Butler JA, Wollenberg GK, Sistare FD, DeGeorge JJ.

Regul Toxicol Pharmacol. 2016 Dec;82:94-98. doi: 10.1016/j.yrtph.2016.10.010. Epub 2016 Oct 18.

PMID:
27769827
16.

Toxicogenomics in drug development: a match made in heaven?

Qin C, Tanis KQ, Podtelezhnikov AA, Glaab WE, Sistare FD, DeGeorge JJ.

Expert Opin Drug Metab Toxicol. 2016 Aug;12(8):847-9. doi: 10.1080/17425255.2016.1175437. Epub 2016 Apr 21. No abstract available.

PMID:
27050123
17.

Regulatory Forum Commentary* Counterpoint: Dose Selection for Tg.rasH2 Mouse Carcinogenicity Studies.

Darbes J, Sistare FD, DeGeorge JJ.

Toxicol Pathol. 2015 Jul;43(5):621-7. doi: 10.1177/0192623315587722. Epub 2015 Jun 4.

PMID:
26047967
18.

Evaluation of the relative performance of 12 urinary biomarkers for renal safety across 22 rat sensitivity and specificity studies.

Vlasakova K, Erdos Z, Troth SP, McNulty K, Chapeau-Campredon V, Mokrzycki N, Muniappa N, Gu YZ, Holder D, Bailey WJ, Sistare FD, Glaab WE.

Toxicol Sci. 2014 Mar;138(1):3-20. doi: 10.1093/toxsci/kft330. Epub 2013 Dec 21.

PMID:
24361871
19.

Regulatory Forum commentary: alternative mouse models for future cancer risk assessment.

Morton D, Sistare FD, Nambiar PR, Turner OC, Radi Z, Bower N.

Toxicol Pathol. 2014 Jul;42(5):799-806. doi: 10.1177/0192623313502130. Epub 2013 Aug 21.

PMID:
23965809
20.

Inhibin B response to testicular toxicants hexachlorophene, ethane dimethane sulfonate, di-(n-butyl)-phthalate, nitrofurazone, DL-ethionine, 17-alpha ethinylestradiol, 2,5-hexanedione, or carbendazim following short-term dosing in male rats.

Erdos Z, Pearson K, Goedken M, Menzel K, Sistare FD, Glaab WE, Saldutti LP.

Birth Defects Res B Dev Reprod Toxicol. 2013 Feb;98(1):41-53. doi: 10.1002/bdrb.21035. Epub 2013 Jan 24.

PMID:
23348767
21.

A performance evaluation of three drug-induced liver injury biomarkers in the rat: alpha-glutathione S-transferase, arginase 1, and 4-hydroxyphenyl-pyruvate dioxygenase.

Bailey WJ, Holder D, Patel H, Devlin P, Gonzalez RJ, Hamilton V, Muniappa N, Hamlin DM, Thomas CE, Sistare FD, Glaab WE.

Toxicol Sci. 2012 Dec;130(2):229-44. doi: 10.1093/toxsci/kfs243. Epub 2012 Aug 7.

PMID:
22872058
22.

Promise of new translational safety biomarkers in drug development and challenges to regulatory qualification.

Sistare FD, DeGeorge JJ.

Biomark Med. 2011 Aug;5(4):497-514. doi: 10.2217/bmm.11.52. Review.

PMID:
21861671
23.

An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.

Sistare FD, Morton D, Alden C, Christensen J, Keller D, Jonghe SD, Storer RD, Reddy MV, Kraynak A, Trela B, Bienvenu JG, Bjurström S, Bosmans V, Brewster D, Colman K, Dominick M, Evans J, Hailey JR, Kinter L, Liu M, Mahrt C, Marien D, Myer J, Perry R, Potenta D, Roth A, Sherratt P, Singer T, Slim R, Soper K, Fransson-Steen R, Stoltz J, Turner O, Turnquist S, van Heerden M, Woicke J, DeGeorge JJ.

Toxicol Pathol. 2011 Jun;39(4):716-44. doi: 10.1177/0192623311406935.

PMID:
21666103
24.

A critical review of the effectiveness of rodent pharmaceutical carcinogenesis testing in predicting for human risk.

Alden CL, Lynn A, Bourdeau A, Morton D, Sistare FD, Kadambi VJ, Silverman L.

Vet Pathol. 2011 May;48(3):772-84. doi: 10.1177/0300985811400445. Epub 2011 Mar 7. Review.

PMID:
21383116
25.

The use of in situ perfusion of the rat mesentery as a model to investigate vascular injury directly induced by drugs.

Knapton AD, Zhang J, Sistare FD, Hanig JP.

Methods Find Exp Clin Pharmacol. 2010 Sep;32(7):489-97. doi: 10.1358/mf.2010.32.7.1507854.

PMID:
21069100
26.

A systematic approach to preclinical and clinical safety biomarker qualification incorporating Bradford Hill's principles of causality association.

Chetty RK, Ozer JS, Lanevschi A, Schuppe-Koistinen I, McHale D, Pears JS, Vonderscher J, Sistare FD, Dieterle F.

Clin Pharmacol Ther. 2010 Aug;88(2):260-2. doi: 10.1038/clpt.2010.77. Epub 2010 Jun 30. Review. No abstract available.

PMID:
20592723
27.

An evaluation of chronic 6- and 12-month rat toxicology studies as predictors of 2-year tumor outcome.

Reddy MV, Sistare FD, Christensen JS, Deluca JG, Wollenberg GK, Degeorge JJ.

Vet Pathol. 2010 Jul;47(4):614-29. doi: 10.1177/0300985810373242. Epub 2010 Jun 1.

PMID:
20516294
28.

A panel of urinary biomarkers to monitor reversibility of renal injury and a serum marker with improved potential to assess renal function.

Ozer JS, Dieterle F, Troth S, Perentes E, Cordier A, Verdes P, Staedtler F, Mahl A, Grenet O, Roth DR, Wahl D, Legay F, Holder D, Erdos Z, Vlasakova K, Jin H, Yu Y, Muniappa N, Forest T, Clouse HK, Reynolds S, Bailey WJ, Thudium DT, Topper MJ, Skopek TR, Sina JF, Glaab WE, Vonderscher J, Maurer G, Chibout SD, Sistare FD, Gerhold DL.

Nat Biotechnol. 2010 May;28(5):486-94. doi: 10.1038/nbt.1627.

PMID:
20458319
29.

Kidney injury molecule-1 outperforms traditional biomarkers of kidney injury in preclinical biomarker qualification studies.

Vaidya VS, Ozer JS, Dieterle F, Collings FB, Ramirez V, Troth S, Muniappa N, Thudium D, Gerhold D, Holder DJ, Bobadilla NA, Marrer E, Perentes E, Cordier A, Vonderscher J, Maurer G, Goering PL, Sistare FD, Bonventre JV.

Nat Biotechnol. 2010 May;28(5):478-85. doi: 10.1038/nbt.1623.

30.

Urinary biomarkers trefoil factor 3 and albumin enable early detection of kidney tubular injury.

Yu Y, Jin H, Holder D, Ozer JS, Villarreal S, Shughrue P, Shi S, Figueroa DJ, Clouse H, Su M, Muniappa N, Troth SP, Bailey W, Seng J, Aslamkhan AG, Thudium D, Sistare FD, Gerhold DL.

Nat Biotechnol. 2010 May;28(5):470-7. doi: 10.1038/nbt.1624.

PMID:
20458317
31.

Towards consensus practices to qualify safety biomarkers for use in early drug development.

Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu YZ, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Lima BS, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal JM, Vonderscher J, Walker E, Webb C, Yu Y.

Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10.

PMID:
20458314
32.

Research at the interface of industry, academia and regulatory science.

Mattes WB, Walker EG, Abadie E, Sistare FD, Vonderscher J, Woodcock J, Woosley RL.

Nat Biotechnol. 2010 May;28(5):432-3. doi: 10.1038/nbt0510-432. No abstract available.

PMID:
20458309
33.

Early alterations in heart gene expression profiles associated with doxorubicin cardiotoxicity in rats.

Thompson KL, Rosenzweig BA, Zhang J, Knapton AD, Honchel R, Lipshultz SE, Retief J, Sistare FD, Herman EH.

Cancer Chemother Pharmacol. 2010 Jul;66(2):303-14. doi: 10.1007/s00280-009-1164-9. Epub 2009 Nov 14.

PMID:
19915844
34.

An industry perspective on the utility of short-term carcinogenicity testing in transgenic mice in pharmaceutical development.

Storer RD, Sistare FD, Reddy MV, DeGeorge JJ.

Toxicol Pathol. 2010 Jan;38(1):51-61. doi: 10.1177/0192623309351718. Epub 2009 Nov 5. Review.

PMID:
19893055
35.

Plasma MicroRNAs as sensitive and specific biomarkers of tissue injury.

Laterza OF, Lim L, Garrett-Engele PW, Vlasakova K, Muniappa N, Tanaka WK, Johnson JM, Sina JF, Fare TL, Sistare FD, Glaab WE.

Clin Chem. 2009 Nov;55(11):1977-83. doi: 10.1373/clinchem.2009.131797. Epub 2009 Sep 10.

36.

A rapid urine test for early detection of kidney injury.

Vaidya VS, Ford GM, Waikar SS, Wang Y, Clement MB, Ramirez V, Glaab WE, Troth SP, Sistare FD, Prozialeck WC, Edwards JR, Bobadilla NA, Mefferd SC, Bonventre JV.

Kidney Int. 2009 Jul;76(1):108-14. doi: 10.1038/ki.2009.96. Epub 2009 Apr 22.

37.

Safety assessment of drug metabolites: implications of regulatory guidance and potential application of genetically engineered mouse models that express human P450s.

Powley MW, Frederick CB, Sistare FD, DeGeorge JJ.

Chem Res Toxicol. 2009 Feb;22(2):257-62. doi: 10.1021/tx8004373.

PMID:
19170595
38.

Biomarkers in peripheral blood associated with vascular injury in Sprague-Dawley rats treated with the phosphodiesterase IV inhibitors SCH 351591 or SCH 534385.

Weaver JL, Snyder R, Knapton A, Herman EH, Honchel R, Miller T, Espandiari P, Smith R, Gu YZ, Goodsaid FM, Rosenblum IY, Sistare FD, Zhang J, Hanig J.

Toxicol Pathol. 2008 Oct;36(6):840-9. doi: 10.1177/0192623308322310. Epub 2008 Sep 5.

PMID:
18776166
39.

Histopathology of vascular injury in Sprague-Dawley rats treated with phosphodiesterase IV inhibitor SCH 351591 or SCH 534385.

Zhang J, Snyder RD, Herman EH, Knapton A, Honchel R, Miller T, Espandiari P, Goodsaid FM, Rosenblum IY, Hanig JP, Sistare FD, Weaver JL.

Toxicol Pathol. 2008 Oct;36(6):827-39. doi: 10.1177/0192623308322308. Epub 2008 Sep 5.

PMID:
18776163
40.

Applications of toxicogenomics to nonclinical drug development: regulatory science considerations.

Sistare FD, Degeorge JJ.

Methods Mol Biol. 2008;460:239-61. doi: 10.1007/978-1-60327-048-9_12.

PMID:
18449491
41.

The utility of the K6/ODC transgenic mouse as an alternative short term dermal model for carcinogenicity testing of pharmaceuticals.

Miller TJ, Honchel R, Espandiari P, Knapton A, Zhang J, Sistare FD, Hanig JP.

Regul Toxicol Pharmacol. 2008 Feb;50(1):87-97. Epub 2007 Nov 4.

PMID:
18069108
42.

Diagnosis of drug-induced renal tubular toxicity using global gene expression profiles.

Jiang Y, Gerhold DL, Holder DJ, Figueroa DJ, Bailey WJ, Guan P, Skopek TR, Sistare FD, Sina JF.

J Transl Med. 2007 Oct 1;5:47.

43.

Preclinical predictors of clinical safety: opportunities for improvement.

Sistare FD, DeGeorge JJ.

Clin Pharmacol Ther. 2007 Aug;82(2):210-4. Epub 2007 May 16. Review.

PMID:
17507920
44.

Mechanisms and biomarkers of cardiovascular injury induced by phosphodiesterase inhibitor III SK&F 95654 in the spontaneously hypertensive rat.

Zhang J, Herman EH, Robertson DG, Reily MD, Knapton A, Ratajczak HV, Rifai N, Honchel R, Blanchard KT, Stoll RE, Sistare FD.

Toxicol Pathol. 2006;34(2):152-63.

PMID:
16537294
45.

Use of a mixed tissue RNA design for performance assessments on multiple microarray formats.

Thompson KL, Rosenzweig BA, Pine PS, Retief J, Turpaz Y, Afshari CA, Hamadeh HK, Damore MA, Boedigheimer M, Blomme E, Ciurlionis R, Waring JF, Fuscoe JC, Paules R, Tucker CJ, Fare T, Coffey EM, He Y, Collins PJ, Jarnagin K, Fujimoto S, Ganter B, Kiser G, Kaysser-Kranich T, Sina J, Sistare FD.

Nucleic Acids Res. 2005 Dec 23;33(22):e187.

46.

Alterations in gene expression profiles and the DNA-damage response in ionizing radiation-exposed TK6 cells.

Akerman GS, Rosenzweig BA, Domon OE, Tsai CA, Bishop ME, McGarrity LJ, Macgregor JT, Sistare FD, Chen JJ, Morris SM.

Environ Mol Mutagen. 2005 Mar-Apr;45(2-3):188-205.

PMID:
15657912
47.

Toxicoproteomics: serum proteomic pattern diagnostics for early detection of drug induced cardiac toxicities and cardioprotection.

Petricoin EF, Rajapaske V, Herman EH, Arekani AM, Ross S, Johann D, Knapton A, Zhang J, Hitt BA, Conrads TP, Veenstra TD, Liotta LA, Sistare FD.

Toxicol Pathol. 2004 Mar-Apr;32 Suppl 1:122-30. Review.

PMID:
15209412
48.

Use of transgenic mice in carcinogenicity hazard assessment.

Jacobson-Kram D, Sistare FD, Jacobs AC.

Toxicol Pathol. 2004 Mar-Apr;32 Suppl 1:49-52. Review.

PMID:
15209403
49.

Gene expression profiles and genetic damage in benzo(a)pyrene diol epoxide-exposed TK6 cells.

Akerman GS, Rosenzweig BA, Domon OE, McGarrity LJ, Blankenship LR, Tsai CA, Culp SJ, MacGregor JT, Sistare FD, Chen JJ, Morris SM.

Mutat Res. 2004 May 18;549(1-2):43-64.

PMID:
15120962
50.

Identification of platform-independent gene expression markers of cisplatin nephrotoxicity.

Thompson KL, Afshari CA, Amin RP, Bertram TA, Car B, Cunningham M, Kind C, Kramer JA, Lawton M, Mirsky M, Naciff JM, Oreffo V, Pine PS, Sistare FD.

Environ Health Perspect. 2004 Mar;112(4):488-94.

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