Publications by authors named "Paul B Watkins"

100Publications

The Challenge of Interpreting Alanine Aminotransferase Elevations in Clinical Trials of New Drug Candidates.

Clin Transl Sci 2020 Oct 28. Epub 2020 Oct 28.

Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy and Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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http://dx.doi.org/10.1111/cts.12900DOI Listing
October 2020

Glutamate dehydrogenase as a biomarker for mitotoxicity; insights from furosemide hepatotoxicity in the mouse.

PLoS One 2020 9;15(10):e0240562. Epub 2020 Oct 9.

Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240562PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546462PMC
October 2020

Cannabidiol and Abnormal Liver Chemistries in Healthy Adults: Results of a Phase I Clinical Trial.

Clin Pharmacol Ther 2020 Oct 6. Epub 2020 Oct 6.

Greenwich Biosciences, 5750 Fleet St Ste 200, Carlsbad, CA, USA.

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http://dx.doi.org/10.1002/cpt.2071DOI Listing
October 2020

Pregnancy-Related Hormones Increase Nifedipine Metabolism in Human Hepatocytes by Inducing CYP3A4 Expression.

J Pharm Sci 2020 Sep 12. Epub 2020 Sep 12.

Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address:

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http://dx.doi.org/10.1016/j.xphs.2020.09.013DOI Listing
September 2020

Polygenic architecture informs potential vulnerability to drug-induced liver injury.

Nat Med 2020 10 7;26(10):1541-1548. Epub 2020 Sep 7.

Department of Regenerative Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Kanagawa, Japan.

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http://dx.doi.org/10.1038/s41591-020-1023-0DOI Listing
October 2020

Quantitative Systems Toxicology Modeling Predicts that Reduced Biliary Efflux Contributes to Tolvaptan Hepatotoxicity.

Clin Pharmacol Ther 2020 Aug 3. Epub 2020 Aug 3.

Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.

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http://dx.doi.org/10.1002/cpt.2007DOI Listing
August 2020

Mechanistic Investigations Support Liver Safety of Ubrogepant.

Toxicol Sci 2020 Sep;177(1):84-93

NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.

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http://dx.doi.org/10.1093/toxsci/kfaa093DOI Listing
September 2020

Precision Dosing Priority Criteria: Drug, Disease, and Patient Population Variables.

Front Pharmacol 2020 22;11:420. Epub 2020 Apr 22.

Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.

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http://dx.doi.org/10.3389/fphar.2020.00420DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188913PMC
April 2020

Understanding Idiosyncratic Toxicity: Lessons Learned from Drug-Induced Liver Injury.

J Med Chem 2020 06 21;63(12):6436-6461. Epub 2020 Feb 21.

Institute for Drug Safety Sciences and Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina 27599, United States.

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http://dx.doi.org/10.1021/acs.jmedchem.9b01297DOI Listing
June 2020

HLA associations with infliximab-induced liver injury.

Pharmacogenomics J 2020 10 6;20(5):681-686. Epub 2020 Feb 6.

Emerald Lake Safety, Newport Beach, CA, USA.

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http://dx.doi.org/10.1038/s41397-020-0159-0DOI Listing
October 2020

Quantitative Systems Toxicology Approaches to Understand and Predict Drug-Induced Liver Injury.

Authors:
Paul B Watkins

Clin Liver Dis 2020 02 1;24(1):49-60. Epub 2019 Nov 1.

Institute for Drug Safety Sciences, Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, 6 Davis Drive, PO Box 12137, Research Triangle Park, NC 27709, USA. Electronic address:

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http://dx.doi.org/10.1016/j.cld.2019.09.003DOI Listing
February 2020

Differentiating the Pharmacodynamics and Toxicology of Macrolide and Ketolide Antibiotics.

J Med Chem 2020 06 7;63(12):6462-6473. Epub 2019 Nov 7.

HiQScreen SÃrl, 6, Route de Compois, Vesenaz, 1222 Geneva, Switzerland.

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http://dx.doi.org/10.1021/acs.jmedchem.9b01159DOI Listing
June 2020

Drug-induced liver injury.

Nat Rev Dis Primers 2019 08 22;5(1):58. Epub 2019 Aug 22.

National Institute for Health Research (NIHR) Nottingham Digestive Diseases Biomedical Research Centre, Nottingham University Hospital NHS Trust and University of Nottingham, Nottingham, UK.

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http://dx.doi.org/10.1038/s41572-019-0105-0DOI Listing
August 2019

Novel Mechanisms of Valproate Hepatotoxicity: Impaired Mrp2 Trafficking and Hepatocyte Depolarization.

Toxicol Sci 2019 Jul 31. Epub 2019 Jul 31.

UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC.

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http://dx.doi.org/10.1093/toxsci/kfz154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6760262PMC
July 2019

Idiosyncratic drug-induced liver injury in patients: Detection, severity assessment, and regulatory implications.

Authors:
Paul B Watkins

Adv Pharmacol 2019 30;85:165-193. Epub 2019 Apr 30.

Eshelman School of Pharmacy, Institute for Drug Safety Sciences, University of North Carolina, Chapel Hill, NC, United States. Electronic address:

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http://dx.doi.org/10.1016/bs.apha.2019.02.004DOI Listing
February 2020

The DILI-sim Initiative: Insights into Hepatotoxicity Mechanisms and Biomarker Interpretation.

Authors:
Paul B Watkins

Clin Transl Sci 2019 03;12(2):122-129

Institute for Drug Safety Sciences, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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http://dx.doi.org/10.1111/cts.12629DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6440570PMC
March 2019

Incidence and Etiology of Drug-Induced Liver Injury in Mainland China.

Gastroenterology 2019 06 8;156(8):2230-2241.e11. Epub 2019 Feb 8.

Shanghai Liver Diseases Research Center, 85th Hospital of Nanjing Military Command, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Electronic address:

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http://dx.doi.org/10.1053/j.gastro.2019.02.002DOI Listing
June 2019

Analyzing the Mechanisms Behind Macrolide Antibiotic-Induced Liver Injury Using Quantitative Systems Toxicology Modeling.

Pharm Res 2019 Feb 7;36(3):48. Epub 2019 Feb 7.

DILIsym Services, Inc., a Simulations Plus Company, 6 Davis Drive, PO Box 12317, Research Triangle Park, North Carolina, 27709, USA.

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http://dx.doi.org/10.1007/s11095-019-2582-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373306PMC
February 2019

Bioprinted liver provides early insight into the role of Kupffer cells in TGF-β1 and methotrexate-induced fibrogenesis.

PLoS One 2019 2;14(1):e0208958. Epub 2019 Jan 2.

Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0208958PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6314567PMC
September 2019

Advancing nonclinical innovation and safety in pharmaceutical testing.

Drug Discov Today 2019 02 20;24(2):624-628. Epub 2018 Nov 20.

Physicians Committee for Responsible Medicine, 5100 Wisconsin Ave NW, Ste 400, Washington, DC 20016, USA.

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http://dx.doi.org/10.1016/j.drudis.2018.11.011DOI Listing
February 2019

Serum biomarkers of drug-induced liver injury: Current status and future directions.

J Dig Dis 2019 Jan 5;20(1):2-10. Epub 2018 Dec 5.

Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Research Triangle Park, North Carolina, USA.

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http://doi.wiley.com/10.1111/1751-2980.12684
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http://dx.doi.org/10.1111/1751-2980.12684DOI Listing
January 2019

Correction to: Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience.

Drug Saf 2018 12;41(12):1431-1437

Takeda Pharmaceuticals, Takeda Development Center Americas, Inc., 1 Takeda Pkwy, Deerfield, IL, 60015, USA.

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http://link.springer.com/10.1007/s40264-018-0745-0
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http://dx.doi.org/10.1007/s40264-018-0745-0DOI Listing
December 2018

A Rapid Method to Estimate Hepatocyte Loss Due to Drug-Induced Liver Injury.

Clin Pharmacol Ther 2019 03 2;105(3):746-753. Epub 2018 Nov 2.

Institute for Drug Safety Sciences, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.

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http://doi.wiley.com/10.1002/cpt.1254
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http://dx.doi.org/10.1002/cpt.1254DOI Listing
March 2019

Improving Interpretation of New and Old Serum Biomarkers of Drug-Induced Liver Injury Through Mechanistic Modeling.

Authors:
Paul B Watkins

CPT Pharmacometrics Syst Pharmacol 2018 06 26;7(6):357-359. Epub 2018 Apr 26.

The University of North Carolina at Chapel Hill, Institute for Drug Safety Science, Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.

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http://dx.doi.org/10.1002/psp4.12303DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027730PMC
June 2018

Reply.

Hepatology 2018 06 1;67(6):2481-2482. Epub 2018 May 1.

Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Research Triangle Park, NC.

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http://dx.doi.org/10.1002/hep.29863DOI Listing
June 2018

Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience.

Drug Saf 2018 06;41(6):625-640

Takeda Pharmaceuticals, Takeda Development Center Americas, Inc., 1 Takeda Pkwy, Deerfield, IL, 60015, USA.

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http://dx.doi.org/10.1007/s40264-018-0642-6DOI Listing
June 2018

Optimized Methods to Explore the Mechanistic and Biomarker Potential of Hepatocyte-Derived Exosomes in Drug-Induced Liver Injury.

Toxicol Sci 2018 05;163(1):92-100

Division of Pharmacotherapy and Experimental Therapeutics and Institute for Drug Safety Sciences, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599.

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http://dx.doi.org/10.1093/toxsci/kfy015DOI Listing
May 2018

In silico modeling to optimize interpretation of liver safety biomarkers in clinical trials.

Exp Biol Med (Maywood) 2018 02 2;243(3):300-307. Epub 2017 Nov 2.

1 UNC Institute for Drug Safety Sciences, 2331 Research Triangle Park , NC 27709, USA.

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http://dx.doi.org/10.1177/1535370217740853DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5813867PMC
February 2018

Dose-response in a high density three-dimensional liver device with real-time bioenergetic and metabolic flux quantification.

Toxicol In Vitro 2017 Dec 1;45(Pt 1):119-127. Epub 2017 Sep 1.

Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States. Electronic address:

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http://dx.doi.org/10.1016/j.tiv.2017.08.021DOI Listing
December 2017

The transformation in biomarker detection and management of drug-induced liver injury.

Liver Int 2017 11 8;37(11):1582-1590. Epub 2017 May 8.

Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Research Triangle Park, NC, USA.

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http://dx.doi.org/10.1111/liv.13441DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5632128PMC
November 2017

The role of quantitative systems pharmacology modeling in the prediction and explanation of idiosyncratic drug-induced liver injury.

Drug Metab Pharmacokinet 2017 Feb 21;32(1):40-45. Epub 2016 Nov 21.

DILIsym Services, Inc., 6 Davis Drive, Research Triangle Park, NC 27709, USA.

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http://dx.doi.org/10.1016/j.dmpk.2016.11.008DOI Listing
February 2017

Subtoxic Alterations in Hepatocyte-Derived Exosomes: An Early Step in Drug-Induced Liver Injury?

Toxicol Sci 2016 06 8;151(2):365-75. Epub 2016 Mar 8.

Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599; Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Research Triangle Park, North Carolina 27709;

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http://dx.doi.org/10.1093/toxsci/kfw047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4880137PMC
June 2016

Sandwich-Cultured Hepatocytes as a Tool to Study Drug Disposition and Drug-Induced Liver Injury.

J Pharm Sci 2016 Feb;105(2):443-459

Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599. Electronic address:

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http://dx.doi.org/10.1016/j.xphs.2015.11.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4894499PMC
February 2016

Beyond miR-122: Identification of MicroRNA Alterations in Blood During a Time Course of Hepatobiliary Injury and Biliary Hyperplasia in Rats.

Toxicol Sci 2016 Mar 26;150(1):3-14. Epub 2015 Nov 26.

*Hamner-UNC Institute for Drug Safety Sciences, RTP, North Carolina 27709; Department of Environmental and Occupational Health, The University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205

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http://dx.doi.org/10.1093/toxsci/kfv260DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5009612PMC
March 2016

How to Diagnose and Exclude Drug-Induced Liver Injury.

Authors:
Paul B Watkins

Dig Dis 2015 6;33(4):472-6. Epub 2015 Jul 6.

Hamner-University of North Carolina Institute for Drug Safety Sciences, University of North Carolina, Chapel Hill, N.C., USA.

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http://dx.doi.org/10.1159/000374091DOI Listing
April 2016

Morphological and Functional Characterization and Assessment of iPSC-Derived Hepatocytes for In Vitro Toxicity Testing.

Toxicol Sci 2015 Sep 18;147(1):39-54. Epub 2015 Jun 18.

*The Hamner Institutes for Health Sciences, Research Triangle Park, North Carolina 27709;

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http://dx.doi.org/10.1093/toxsci/kfv117DOI Listing
September 2015

FutureTox II: in vitro data and in silico models for predictive toxicology.

Toxicol Sci 2015 Feb;143(2):256-67

United States Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Sanofi, Bridgewater, New Jersey 08807, Page One Editorial Services, Boulder, Colorado 80304, Dow Chemical Company, Midland, Michigan 48674, Health and Environmental Sciences Institute, Washington, District of Columbia 20005, University of Washington, Seattle, Washington 98105, United States Food and Drug Administration, Silver Spring, Maryland 20993, Sanofi, Bethesda, Maryland 20814, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina 27709, University of North Carolina, Chapel Hill, North Carolina 27599, The Hamner Institutes, Research Triangle Park, North Carolina 27709, and European Commission Joint Research Centre, I-21027 Ispra, Italy.

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https://academic.oup.com/toxsci/article-lookup/doi/10.1093/t
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http://dx.doi.org/10.1093/toxsci/kfu234DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318934PMC
February 2015

Exploring BSEP inhibition-mediated toxicity with a mechanistic model of drug-induced liver injury.

Front Pharmacol 2014 7;5:240. Epub 2014 Nov 7.

The Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes for Health Sciences Research Triangle Park, NC, USA.

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http://dx.doi.org/10.3389/fphar.2014.00240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4224072PMC
November 2014

Liver safety assessment in special populations (hepatitis B, C, and oncology trials).

Drug Saf 2014 Nov;37 Suppl 1:S57-62

Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Raemistrasse 100, 8091, Zurich, Switzerland,

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http://link.springer.com/10.1007/s40264-014-0186-3
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http://dx.doi.org/10.1007/s40264-014-0186-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212149PMC
November 2014

Causality assessment for suspected DILI during clinical phases of drug development.

Drug Saf 2014 Nov;37 Suppl 1:S47-56

Global Patient Safety, Eli Lilly and Company, Lilly Corporate Center, Drop Code 2121, Indianapolis, IN, 46285, USA,

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http://dx.doi.org/10.1007/s40264-014-0185-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212150PMC
November 2014

Methodology to assess clinical liver safety data.

Drug Saf 2014 Nov;37 Suppl 1:S33-45

Discovery and Investigative Safety, Novartis Institutes for BioMedical Research, Klybeckstrasse 141, WKL-135.1.78, 4057, Basel, Switzerland,

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http://dx.doi.org/10.1007/s40264-014-0184-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212156PMC
November 2014

Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.

Drug Saf 2014 Nov;37 Suppl 1:S19-31

Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA,

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http://link.springer.com/10.1007/s40264-014-0183-6
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http://dx.doi.org/10.1007/s40264-014-0183-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212151PMC
November 2014

The clinical liver safety assessment best practices workshop: rationale, goals, accomplishments and the future.

Drug Saf 2014 Nov;37 Suppl 1:S1-7

The Hamner-University of North Carolina Institute for Drug Safety Sciences, 6 Davis Drive, PO Box 12137, Research Triangle Park, NC, 27709, USA,

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http://dx.doi.org/10.1007/s40264-014-0181-8DOI Listing
November 2014

Benign elevations in serum aminotransferases and biomarkers of hepatotoxicity in healthy volunteers treated with cholestyramine.

BMC Pharmacol Toxicol 2014 Aug 3;15:42. Epub 2014 Aug 3.

The Hamner-University of North Carolina Institute for Drug Safety Sciences, 6 Davis Drive, Research Triangle Park, NC 27709, USA.

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http://dx.doi.org/10.1186/2050-6511-15-42DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4130124PMC
August 2014

A systems biology approach utilizing a mouse diversity panel identifies genetic differences influencing isoniazid-induced microvesicular steatosis.

Toxicol Sci 2014 Aug 20;140(2):481-92. Epub 2014 May 20.

Hamner-University of North Carolina Institute for Drug Safety Sciences, The Hamner Institutes for Health Sciences, Research Triangle Park, North Carolina 27709 Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599 The University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205

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http://dx.doi.org/10.1093/toxsci/kfu094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4168290PMC
August 2014

Liver biomarker and in vitro assessment confirm the hepatic origin of aminotransferase elevations lacking histopathological correlate in beagle dogs treated with GABAA receptor antagonist NP260.

Toxicol Appl Pharmacol 2014 Jun 31;277(2):131-7. Epub 2014 Mar 31.

The Institute for Chemical Safety Sciences, The Hamner Institutes for Health Sciences, Research Triangle Park, NC 27709, USA.

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http://dx.doi.org/10.1016/j.taap.2014.03.015DOI Listing
June 2014

Use of a systems model of drug-induced liver injury (DILIsym(®)) to elucidate the mechanistic differences between acetaminophen and its less-toxic isomer, AMAP, in mice.

Toxicol Lett 2014 Apr 18;226(2):163-72. Epub 2014 Feb 18.

The Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes, 6 Davis Drive, Research Triangle Park, NC 27709, United States.

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http://dx.doi.org/10.1016/j.toxlet.2014.02.007DOI Listing
April 2014

Profiles of serum cytokines in acute drug-induced liver injury and their prognostic significance.

PLoS One 2013 27;8(12):e81974. Epub 2013 Dec 27.

The Liver-Biliary-Pancreatic Center and Departments of Internal Medicine, General Surgery, Research, and Dickson Advanced Analytics, Carolinas Medical Center, Charlotte, North Carolina, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0081974PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3873930PMC
September 2014

Linking physiology to toxicity using DILIsym®, a mechanistic mathematical model of drug-induced liver injury.

Biopharm Drug Dispos 2014 Jan 25;35(1):33-49. Epub 2013 Nov 25.

The Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes, Research Triangle Park, NC, 27709, USA.

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http://dx.doi.org/10.1002/bdd.1878DOI Listing
January 2014

Anti-tuberculosis drug-induced liver injury in Shanghai: validation of Hy's Law.

Drug Saf 2014 Jan;37(1):43-51

Shanghai Municipal Center for Disease Control and Prevention, 1380 Zhong Shan Road (W), Shanghai, 200336, China.

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http://dx.doi.org/10.1007/s40264-013-0119-6DOI Listing
January 2014

Serum acute phase reactants hallmark healthy individuals at risk for acetaminophen-induced liver injury.

Genome Med 2013 27;5(9):86. Epub 2013 Sep 27.

The Hamner Institutes for Health Sciences, 6 Davis Drive, Research Triangle Park, Box 12137, Durham, NC 27709, USA.

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http://dx.doi.org/10.1186/gm493DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3979026PMC
May 2014

The new revolution in toxicology: the good, the bad, and the ugly.

Ann N Y Acad Sci 2013 Mar;1278:11-24

Toxicology and Pharmacology Branch, Developmental Therapeutics Program Division of Cancer Treatment and Diagnosis, The National Cancer Institute, National Institutes of Health, Bethesda, MD 20852, USA.

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http://dx.doi.org/10.1111/nyas.12086DOI Listing
March 2013

Modeling drug- and chemical-induced hepatotoxicity with systems biology approaches.

Front Physiol 2012 14;3:462. Epub 2012 Dec 14.

Institute for Chemical Safety Sciences, The Hamner Institutes for Health Sciences Research Triangle Park, NC, USA.

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http://dx.doi.org/10.3389/fphys.2012.00462DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3522076PMC
December 2012

Current challenges and controversies in drug-induced liver injury.

Drug Saf 2012 Dec;35(12):1099-117

Dipartimento di Scienze Farmacologiche e Biomolecolari, Universit degli Studi di Milano, Milan, Italy.

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http://dx.doi.org/10.1007/BF03261997DOI Listing
December 2012

Combination lopinavir and ritonavir alter exogenous and endogenous bile acid disposition in sandwich-cultured rat hepatocytes.

Drug Metab Dispos 2013 Jan 22;41(1):188-96. Epub 2012 Oct 22.

Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

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http://dmd.aspetjournals.org/cgi/doi/10.1124/dmd.112.047225
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http://dx.doi.org/10.1124/dmd.112.047225DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3533430PMC
January 2013

A mouse diversity panel approach reveals the potential for clinical kidney injury due to DB289 not predicted by classical rodent models.

Toxicol Sci 2012 Dec 31;130(2):416-26. Epub 2012 Aug 31.

The Hamner Institutes for Health Sciences, Hamner-University of North Carolina Institute for Drug Safety Sciences, Durham, North Carolina 27709, USA.

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https://academic.oup.com/toxsci/article-lookup/doi/10.1093/t
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http://dx.doi.org/10.1093/toxsci/kfs238DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3498743PMC
December 2012

In vitro to in vivo extrapolation and species response comparisons for drug-induced liver injury (DILI) using DILIsym™: a mechanistic, mathematical model of DILI.

J Pharmacokinet Pharmacodyn 2012 Oct 9;39(5):527-41. Epub 2012 Aug 9.

The Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes, Durham, NC 27709, USA.

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http://dx.doi.org/10.1007/s10928-012-9266-0DOI Listing
October 2012

Effect of oxygen concentration on viability and metabolism in a fluidized-bed bioartificial liver using ³¹P and ¹³C NMR spectroscopy.

Tissue Eng Part C Methods 2013 Feb 28;19(2):93-100. Epub 2012 Sep 28.

Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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March 2011