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

Mosedale M, Watkins PB.

J Med Chem. 2020 Feb 9. doi: 10.1021/acs.jmedchem.9b01297. [Epub ahead of print]


HLA associations with infliximab-induced liver injury.

Bruno CD, Fremd B, Church RJ, Daly AK, Aithal GP, Björnsson ES, Larrey D, Watkins PB, Chow CR.

Pharmacogenomics J. 2020 Feb 6. doi: 10.1038/s41397-020-0159-0. [Epub ahead of print]


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

Watkins PB.

Clin Liver Dis. 2020 Feb;24(1):49-60. doi: 10.1016/j.cld.2019.09.003. Epub 2019 Nov 1. Review.


Differentiating the Pharmacodynamics and Toxicology of Macrolide and Ketolide Antibiotics.

Fernandes P, Pereira D, Watkins PB, Bertrand D.

J Med Chem. 2019 Nov 7. doi: 10.1021/acs.jmedchem.9b01159. [Epub ahead of print]


Quantitative systems toxicology (QST) reproduces species differences in PF-04895162 liver safety due to combined mitochondrial and bile acid toxicity.

Generaux G, Lakhani VV, Yang Y, Nadanaciva S, Qiu L, Riccardi K, Di L, Howell BA, Siler SQ, Watkins PB, Barton HA, Aleo MD, Shoda LKM.

Pharmacol Res Perspect. 2019 Oct 9;7(6):e00523. doi: 10.1002/prp2.523. eCollection 2019 Dec.


Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: Randomized, placebo-controlled trial in healthy adults.

Goadsby PJ, Tepper SJ, Watkins PB, Ayele G, Miceli R, Butler M, Severt L, Finnegan M, Szegedi A, Trugman JM, Jakate A.

Cephalalgia. 2019 Dec;39(14):1753-1761. doi: 10.1177/0333102419869918. Epub 2019 Sep 19.


Identification of Candidate Risk Factor Genes for Human Idelalisib Toxicity Using a Collaborative Cross Approach.

Mosedale M, Cai Y, Eaddy JS, Corty RW, Nautiyal M, Watkins PB, Valdar W.

Toxicol Sci. 2019 Dec 1;172(2):265-278. doi: 10.1093/toxsci/kfz199.


Drug-induced liver injury.

Andrade RJ, Chalasani N, Björnsson ES, Suzuki A, Kullak-Ublick GA, Watkins PB, Devarbhavi H, Merz M, Lucena MI, Kaplowitz N, Aithal GP.

Nat Rev Dis Primers. 2019 Aug 22;5(1):58. doi: 10.1038/s41572-019-0105-0. Review.


Genetic Polymorphisms Implicated in Nonalcoholic Liver Disease or Selected Other Disorders Have No Influence on Drug-Induced Liver Injury.

Bonkovsky HL, Severson T, Nicoletti P, Barnhart H, Serrano J, Chalasani N, Fontana RJ, Watkins PB, Navarro V, Stolz A, Daly AK, Aithal GP, Odin J; US DILIN Investigators.

Hepatol Commun. 2019 Jun 6;3(8):1032-1035. doi: 10.1002/hep4.1382. eCollection 2019 Aug.


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

Fu D, Cardona P, Ho H, Watkins PB, Brouwer KLR.

Toxicol Sci. 2019 Jul 31. pii: kfz154. doi: 10.1093/toxsci/kfz154. [Epub ahead of print]


Next-Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development.

Roth SE, Avigan MI, Bourdet D, Brott D, Church R, Dash A, Keller D, Sherratt P, Watkins PB, Westcott-Baker L, Lentini S, Merz M, Ramaiah L, Ramaiah SK, Stanley AM, Marcinak J.

Clin Pharmacol Ther. 2020 Feb;107(2):333-346. doi: 10.1002/cpt.1571. Epub 2019 Sep 14. Review.


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

Watkins PB.

Adv Pharmacol. 2019;85:165-193. doi: 10.1016/bs.apha.2019.02.004. Epub 2019 Apr 30. Review.


Hepatocyte-Derived Exosomes Promote Liver Immune Tolerance: Possible Implications for Idiosyncratic Drug-Induced Liver Injury.

Holman NS, Church RJ, Nautiyal M, Rose KA, Thacker SE, Otieno MA, Wolf KK, LeCluyse E, Watkins PB, Mosedale M.

Toxicol Sci. 2019 Aug 1;170(2):499-508. doi: 10.1093/toxsci/kfz112.


Shared Genetic Risk Factors Across Carbamazepine-Induced Hypersensitivity Reactions.

Nicoletti P, Barrett S, McEvoy L, Daly AK, Aithal G, Lucena MI, Andrade RJ, Wadelius M, Hallberg P, Stephens C, Bjornsson ES, Friedmann P, Kainu K, Laitinen T, Marson A, Molokhia M, Phillips E, Pichler W, Romano A, Shear N, Sills G, Tanno LK, Swale A, Floratos A, Shen Y, Nelson MR, Watkins PB, Daly MJ, Morris AP, Alfirevic A, Pirmohamed M.

Clin Pharmacol Ther. 2019 Nov;106(5):1028-1036. doi: 10.1002/cpt.1493. Epub 2019 Jul 3.


Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program.

Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB.

Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.


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

Watkins PB.

Clin Transl Sci. 2019 Mar;12(2):122-129. doi: 10.1111/cts.12629. Review.


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

Shen T, Liu Y, Shang J, Xie Q, Li J, Yan M, Xu J, Niu J, Liu J, Watkins PB, Aithal GP, Andrade RJ, Dou X, Yao L, Lv F, Wang Q, Li Y, Zhou X, Zhang Y, Zong P, Wan B, Zou Z, Yang D, Nie Y, Li D, Wang Y, Han X, Zhuang H, Mao Y, Chen C.

Gastroenterology. 2019 Jun;156(8):2230-2241.e11. doi: 10.1053/j.gastro.2019.02.002. Epub 2019 Feb 8.


Correction: Cytokine profiles in acute liver injury-Results from the US Drug-Induced Liver Injury Network (DILIN) and the Acute Liver Failure Study Group.

Bonkovsky HL, Barnhart HX, Foureau DM, Steuerwald N, Lee WM, Gu J, Fontana RJ, Hayashi PH, Chalasani N, Navarro VM, Odin J, Stolz A, Watkins PB, Serrano J; US Drug-Induced Liver Injury Network and the Acute Liver Failure Study Group.

PLoS One. 2019 Feb 11;14(2):e0212394. doi: 10.1371/journal.pone.0212394. eCollection 2019.


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

Woodhead JL, Yang K, Oldach D, MacLauchlin C, Fernandes P, Watkins PB, Siler SQ, Howell BA.

Pharm Res. 2019 Feb 7;36(3):48. doi: 10.1007/s11095-019-2582-y.


A Missense Variant in PTPN22 is a Risk Factor for Drug-induced Liver Injury.

Cirulli ET, Nicoletti P, Abramson K, Andrade RJ, Bjornsson ES, Chalasani N, Fontana RJ, Hallberg P, Li YJ, Lucena MI, Long N, Molokhia M, Nelson MR, Odin JA, Pirmohamed M, Rafnar T, Serrano J, Stefánsson K, Stolz A, Daly AK, Aithal GP, Watkins PB; Drug-Induced Liver Injury Network (DILIN) investigators; International DILI consortium (iDILIC).

Gastroenterology. 2019 May;156(6):1707-1716.e2. doi: 10.1053/j.gastro.2019.01.034. Epub 2019 Jan 18.


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

Norona LM, Nguyen DG, Gerber DA, Presnell SC, Mosedale M, Watkins PB.

PLoS One. 2019 Jan 2;14(1):e0208958. doi: 10.1371/journal.pone.0208958. eCollection 2019.


Advancing nonclinical innovation and safety in pharmaceutical testing.

Baker EJ, Beck NA, Berg EL, Clayton-Jeter HD, Chandrasekera PC, Curley JL, Donzanti BA, Ewart LC, Gunther JM, Kenna JG, LeCluyse EL, Liebman MN, Pugh CL, Watkins PB, Sullivan KM.

Drug Discov Today. 2019 Feb;24(2):624-628. doi: 10.1016/j.drudis.2018.11.011. Epub 2018 Nov 20. Review.


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

Church RJ, Watkins PB.

J Dig Dis. 2019 Jan;20(1):2-10. doi: 10.1111/1751-2980.12684. Epub 2018 Dec 5. Review.


Cytokine profiles in acute liver injury-Results from the US Drug-Induced Liver Injury Network (DILIN) and the Acute Liver Failure Study Group.

Bonkovsky HL, Barnhart HX, Foureau DM, Steuerwald N, Lee WM, Gu J, Fontana RJ, Hayashi PJ, Chalasani N, Navarro VM, Odin J, Stolz A, Watkins PB, Serrano J; US Drug-Induced Liver Injury Network and the Acute Liver Failure Study Group.

PLoS One. 2018 Oct 25;13(10):e0206389. doi: 10.1371/journal.pone.0206389. eCollection 2018. Erratum in: PLoS One. 2019 Feb 11;14(2):e0212394.


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

Marcinak JF, Munsaka MS, Watkins PB, Ohira T, Smith N.

Drug Saf. 2018 Dec;41(12):1431-1437. doi: 10.1007/s40264-018-0745-0.


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

Chung JY, Longo DM, Watkins PB.

Clin Pharmacol Ther. 2019 Mar;105(3):746-753. doi: 10.1002/cpt.1254. Epub 2018 Nov 2.


Quantitative Systems Toxicology Analysis of In Vitro Mechanistic Assays Reveals Importance of Bile Acid Accumulation and Mitochondrial Dysfunction in TAK-875-Induced Liver Injury.

Longo DM, Woodhead JL, Walker P, Herédi-Szabó K, Mogyorósi K, Wolenski FS, Dragan YP, Mosedale M, Siler SQ, Watkins PB, Howell BA.

Toxicol Sci. 2019 Feb 1;167(2):458-467. doi: 10.1093/toxsci/kfy253.


The role of HLA-A*33:01 in patients with cholestatic hepatitis attributed to terbinafine.

Fontana RJ, Cirulli ET, Gu J, Kleiner D, Ostrov D, Phillips E, Schutte R, Barnhart H, Chalasani N, Watkins PB, Hoofnagle JH.

J Hepatol. 2018 Dec;69(6):1317-1325. doi: 10.1016/j.jhep.2018.08.004. Epub 2018 Aug 21.


Can Bile Salt Export Pump 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, Pak YA, Pedersen JM, Polli JW, Rodrigues AD, Watkins PB, Yang K, Yucha RW; International Transporter Consortium.

Clin Pharmacol Ther. 2018 Nov;104(5):916-932. doi: 10.1002/cpt.1222. Review.


Using Quantitative Systems Toxicology to Investigate Observed Species Differences in CKA-Mediated Hepatotoxicity.

Battista C, Yang K, Stahl SH, Mettetal JT, Watkins PB, Siler SQ, Howell BA.

Toxicol Sci. 2018 Nov 1;166(1):123-130. doi: 10.1093/toxsci/kfy191.


Prediction of Safety Margin and Optimization of Dosing Protocol for a Novel Antibiotic using Quantitative Systems Pharmacology Modeling.

Woodhead JL, Paech F, Maurer M, Engelhardt M, Schmitt-Hoffmann AH, Spickermann J, Messner S, Wind M, Witschi AT, Krähenbühl S, Siler SQ, Watkins PB, Howell BA.

Clin Transl Sci. 2018 Sep;11(5):498-505. doi: 10.1111/cts.12560. Epub 2018 Jun 7.


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

Watkins PB.

CPT Pharmacometrics Syst Pharmacol. 2018 Jun;7(6):357-359. doi: 10.1002/psp4.12303. Epub 2018 Apr 26.



Church RJ, Watkins PB.

Hepatology. 2018 Jun;67(6):2481-2482. doi: 10.1002/hep.29863. Epub 2018 May 1. No abstract available.


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

Marcinak JF, Munsaka MS, Watkins PB, Ohira T, Smith N.

Drug Saf. 2018 Jun;41(6):625-640. doi: 10.1007/s40264-018-0642-6. Erratum in: Drug Saf. 2018 Dec;41(12):1431-1437.


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

Thacker SE, Nautiyal M, Otieno MA, Watkins PB, Mosedale M.

Toxicol Sci. 2018 May 1;163(1):92-100. doi: 10.1093/toxsci/kfy015.


Candidate biomarkers for the diagnosis and prognosis of drug-induced liver injury: An international collaborative effort.

Church RJ, Kullak-Ublick GA, Aubrecht J, Bonkovsky HL, Chalasani N, Fontana RJ, Goepfert JC, Hackman F, King NMP, Kirby S, Kirby P, Marcinak J, Ormarsdottir S, Schomaker SJ, Schuppe-Koistinen I, Wolenski F, Arber N, Merz M, Sauer JM, Andrade RJ, van Bömmel F, Poynard T, Watkins PB.

Hepatology. 2019 Feb;69(2):760-773. doi: 10.1002/hep.29802. Epub 2018 Jun 27.


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

Church RJ, Watkins PB.

Exp Biol Med (Maywood). 2018 Feb;243(3):300-307. doi: 10.1177/1535370217740853. Epub 2017 Nov 2. Review.


Transient Changes in Hepatic Physiology That Alter Bilirubin and Bile Acid Transport May Explain Elevations in Liver Chemistries Observed in Clinical Trials of GGF2 (Cimaglermin Alfa).

Mosedale M, Button D, Jackson JP, Freeman KM, Brouwer KR, Caggiano AO, Eisen A, Iaci JF, Parry TJ, Stanulis R, Srinivas M, Watkins PB.

Toxicol Sci. 2018 Feb 1;161(2):401-411. doi: 10.1093/toxsci/kfx222.


miR-122 Release in Exosomes Precedes Overt Tolvaptan-Induced Necrosis in a Primary Human Hepatocyte Micropatterned Coculture Model.

Mosedale M, Eaddy JS, Trask OJ Jr, Holman NS, Wolf KK, LeCluyse E, Ware BR, Khetani SR, Lu J, Brock WJ, Roth SE, Watkins PB.

Toxicol Sci. 2018 Jan 1;161(1):149-158. doi: 10.1093/toxsci/kfx206.


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

Tikunov AP, Shim YS, Bhattarai N, Siler SQ, Soldatow V, LeCluyse EL, McDunn JE, Watkins PB, Macdonald JM.

Toxicol In Vitro. 2017 Dec;45(Pt 1):119-127. doi: 10.1016/j.tiv.2017.08.021. Epub 2017 Sep 1.


Mechanistic Modelling of Drug-Induced Liver Injury: Investigating the Role of Innate Immune Responses.

Shoda LK, Battista C, Siler SQ, Pisetsky DS, Watkins PB, Howell BA.

Gene Regul Syst Bio. 2017 May 30;11:1177625017696074. doi: 10.1177/1177625017696074. eCollection 2017.


Refining Liver Safety Risk Assessment: Application of Mechanistic Modeling and Serum Biomarkers to Cimaglermin Alfa (GGF2) Clinical Trials.

Longo DM, Generaux GT, Howell BA, Siler SQ, Antoine DJ, Button D, Caggiano A, Eisen A, Iaci J, Stanulis R, Parry T, Mosedale M, Watkins PB.

Clin Pharmacol Ther. 2017 Dec;102(6):961-969. doi: 10.1002/cpt.711. Epub 2017 May 27.


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

Church RJ, Watkins PB.

Liver Int. 2017 Nov;37(11):1582-1590. doi: 10.1111/liv.13441. Epub 2017 May 8. Review.


Minocycline hepatotoxicity: Clinical characterization and identification of HLA-B∗35:02 as a risk factor.

Urban TJ, Nicoletti P, Chalasani N, Serrano J, Stolz A, Daly AK, Aithal GP, Dillon J, Navarro V, Odin J, Barnhart H, Ostrov D, Long N, Cirulli ET, Watkins PB, Fontana RJ; Drug-Induced Liver Injury Network (DILIN); Pharmacogenetics of Drug-Induced Liver Injury group (DILIGEN); International Serious Adverse Events Consortium (iSAEC).

J Hepatol. 2017 Jul;67(1):137-144. doi: 10.1016/j.jhep.2017.03.010. Epub 2017 Mar 18.


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

Woodhead JL, Watkins PB, Howell BA, Siler SQ, Shoda LKM.

Drug Metab Pharmacokinet. 2017 Feb;32(1):40-45. doi: 10.1016/j.dmpk.2016.11.008. Epub 2016 Nov 21. Review.


Editor's Highlight: Candidate Risk Factors and Mechanisms for Tolvaptan-Induced Liver Injury Are Identified Using a Collaborative Cross Approach.

Mosedale M, Kim Y, Brock WJ, Roth SE, Wiltshire T, Eaddy JS, Keele GR, Corty RW, Xie Y, Valdar W, Watkins PB.

Toxicol Sci. 2017 Apr 1;156(2):438-454. doi: 10.1093/toxsci/kfw269.


Systems pharmacology modeling of drug-induced hyperbilirubinemia: Differentiating hepatotoxicity and inhibition of enzymes/transporters.

Yang K, Battista C, Woodhead JL, Stahl SH, Mettetal JT, Watkins PB, Siler SQ, Howell BA.

Clin Pharmacol Ther. 2017 Apr;101(4):501-509. doi: 10.1002/cpt.619. Epub 2017 Feb 17.


Association of Liver Injury From Specific Drugs, or Groups of Drugs, With Polymorphisms in HLA and Other Genes in a Genome-Wide Association Study.

Nicoletti P, Aithal GP, Bjornsson ES, Andrade RJ, Sawle A, Arrese M, Barnhart HX, Bondon-Guitton E, Hayashi PH, Bessone F, Carvajal A, Cascorbi I, Cirulli ET, Chalasani N, Conforti A, Coulthard SA, Daly MJ, Day CP, Dillon JF, Fontana RJ, Grove JI, Hallberg P, Hernández N, Ibáñez L, Kullak-Ublick GA, Laitinen T, Larrey D, Lucena MI, Maitland-van der Zee AH, Martin JH, Molokhia M, Pirmohamed M, Powell EE, Qin S, Serrano J, Stephens C, Stolz A, Wadelius M, Watkins PB, Floratos A, Shen Y, Nelson MR, Urban TJ, Daly AK; International Drug-Induced Liver Injury Consortium, Drug-Induced Liver Injury Network Investigators, and International Serious Adverse Events Consortium.

Gastroenterology. 2017 Apr;152(5):1078-1089. doi: 10.1053/j.gastro.2016.12.016. Epub 2016 Dec 30.


Drug-induced liver injury: Advances in mechanistic understanding that will inform risk management.

Mosedale M, Watkins PB.

Clin Pharmacol Ther. 2017 Apr;101(4):469-480. doi: 10.1002/cpt.564. Epub 2017 Jan 11. Review.


Profiles of miRNAs in serum in severe acute drug induced liver injury and their prognostic significance.

Russo MW, Steuerwald N, Norton HJ, Anderson WE, Foureau D, Chalasani N, Fontana RJ, Watkins PB, Serrano J, Bonkovsky HL.

Liver Int. 2017 May;37(5):757-764. doi: 10.1111/liv.13312. Epub 2016 Nov 29.

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