Search Results - "WATKINS, P. B"

Case Definition and Phenotype Standardization in Drug-Induced Liver Injury by Aithal, GP, Watkins, PB, Andrade, RJ, Larrey, D, Molokhia, M, Takikawa, H, Hunt, CM, Wilke, RA, Avigan, M, Kaplowitz, N, Bjornsson, E, Daly, AK

“…Drug‐induced liver injury (DILI) is the most frequent reason cited for the withdrawal of approved drugs from the market and accounts for up to 15% of the cases…”
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Drug‐induced liver injury: Advances in mechanistic understanding that will inform risk management by Mosedale, M, Watkins, PB

“…Drug‐induced liver injury (DILI) is a major public health problem. Intrinsic (dose‐dependent) DILI associated with acetaminophen overdose is the number one…”
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Drug Safety Sciences and the Bottleneck in Drug Development by Watkins, PB

“…During a recent review of a new drug application for treatment of a chronic disease, US Food and Drug Administration (FDA) regulators agreed with the sponsor's…”
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Use of Pharmaco-Metabonomics for Early Prediction of Acetaminophen-Induced Hepatotoxicity in Humans by Winnike, J H, Li, Z, Wright, F A, Macdonald, J M, O'Connell, T M, Watkins, P B

“…Achieving the ability to identify individuals who are susceptible to drug‐induced liver injury (DILI) would represent a major advance in personalized medicine…”
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The Application of Metabonomics to Predict Drug-Induced Liver Injury by O'Connell, T M, Watkins, P B

“…The occurrence of drug‐induced liver injury (DILI) presents a significant safety issue for patients and represents a major cause of regulatory action. The…”
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The Effects of Heparins on the Liver: Application of Mechanistic Serum Biomarkers in a Randomized Study in Healthy Volunteers by Harrill, A H, Roach, J, Fier, I, Eaddy, J S, Kurtz, C L, Antoine, D J, Spencer, D M, Kishimoto, T K, Pisetsky, D S, Park, B K, Watkins, P B

“…Heparins have been reported to cause elevations in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) but have not been associated with…”
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Comparative analysis of portal hepatic infiltrating leucocytes in acute drug‐induced liver injury, idiopathic autoimmune and viral hepatitis by Foureau, D. M., Walling, T. L., Maddukuri, V., Anderson, W., Culbreath, K., Kleiner, D. E., Ahrens, W. A., Jacobs, C., Watkins, P. B., Fontana, R. J., Chalasani, N., Talwalkar, J., Lee, W. M., Stolz, A., Serrano, J., Bonkovsky, H. L.

“…Summary Drug‐induced liver injury (DILI) is often caused by innate and adaptive host immune responses. Characterization of inflammatory infiltrates in the…”
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MITOsym®: A Mechanistic, Mathematical Model of Hepatocellular Respiration and Bioenergetics by Yang, Y., Nadanaciva, S., Will, Y., Woodhead, J. L., Howell, B. A., Watkins, P. B., Siler, S. Q.

“…Purpose MITOsym, a new mathematical model of hepatocellular respiration and bioenergetics, has been developed in partnership with the DILIsym® model with the…”
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Serum proteomic profiling in patients with drug-induced liver injury by Bell, L. N., Vuppalanchi, R., Watkins, P. B., Bonkovsky, H. L., Serrano, J., Fontana, R. J., Wang, M., Rochon, J., Chalasani, N.

“…Summary Background Idiosyncratic drug‐induced liver injury (DILI) is a complex disorder that is difficult to predict, diagnose and treat. Aim To describe the…”
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Interactions between seabirds and deep-water hake trawl gear: an assessment of impacts in South African waters by Watkins, B.P, Petersen, S.L, Ryan, P.G

“…Many seabirds are killed or injured by fishing gear, contributing to the high proportion of threatened seabirds. This study estimates the impact of the South…”
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Refining Liver Safety Risk Assessment: Application of Mechanistic Modeling and Serum Biomarkers to Cimaglermin Alfa (GGF2) Clinical Trials by 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

“…Cimaglermin alfa (GGF2) is a recombinant human protein growth factor in development for heart failure. Phase I trials were suspended when two cimaglermin…”
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Systems pharmacology modeling of drug‐induced hyperbilirubinemia: Differentiating hepatotoxicity and inhibition of enzymes/transporters by Yang, K, Battista, C, Woodhead, JL, Stahl, SH, Mettetal, JT, Watkins, PB, Siler, SQ, Howell, BA

“…Elevations in serum bilirubin during drug treatment may indicate global liver dysfunction and a high risk of liver failure. However, drugs also can increase…”
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Blood gene expression signatures predict exposure levels by Bushel, P.R, Heinloth, A.N, Li, J, Huang, L, Chou, J.W, Boorman, G.A, Malarkey, D.E, Houle, C.D, Ward, S.M, Wilson, R.E, Fannin, R.D, Russo, M.W, Watkins, P.B, Tennant, R.W, Paules, R.S

“…To respond to potential adverse exposures properly, health care providers need accurate indicators of exposure levels. The indicators are particularly…”
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Elucidating Differences in the Hepatotoxic Potential of Tolcapone and Entacapone With DILIsym®, a Mechanistic Model of Drug‐Induced Liver Injury by Longo, DM, Yang, Y, Watkins, PB, Howell, BA, Siler, SQ

“…Tolcapone and entacapone are catechol‐O‐methyltransferase (COMT) inhibitors developed as adjunct therapies for treating Parkinson's disease. While both drugs…”
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Blood transcript immune signatures distinguish a subset of people with elevated serum ALT from others given acetaminophen by Fannin, RD, Gerrish, K, Sieber, SO, Bushel, PR, Watkins, PB, Paules, RS

“…The diagnosis of drug‐induced liver injury is hindered by the limited utility of clinical chemistries. We have shown that hepatotoxicants can produce…”
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Hepatic Dysfunction Associated with Troglitazone by Watkins, Paul B, Whitcomb, Randall W

“…To the Editor: Troglitazone is a thiazolidine 2,4-dione derivative that represents a novel class of oral drugs for the treatment of diabetes. In clinical…”
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A Mechanistic Model of Drug‐Induced Liver Injury Aids the Interpretation of Elevated Liver Transaminase Levels in a Phase I Clinical Trial by Howell, BA, Siler, SQ, Shoda, LKM, Yang, Y, Woodhead, JL, Watkins, PB

“…Entolimod (CBLB502) is a Toll‐like receptor 5 agonist in development as a single‐dose countermeasure against total body irradiation. Efficacy can be assessed…”
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Interpatient heterogeneity in expression of CYP3A4 and CYP3A5 in small bowel. Lack of prediction by the erythromycin breath test by Lown, K S, Kolars, J C, Thummel, K E, Barnett, J L, Kunze, K L, Wrighton, S A, Watkins, P B

“…The CYP3A subfamily of cytochromes P450 metabolize many medications and environmental contaminants. CYP3A4 and, in 25% of patients, CYP3A5 seem to be the major…”
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Managing the Risk of Drug-Induced Liver Injury by Watkins, P B

“…In clinical trials, bosentan was shown to cause significant drug‐induced liver injury (DILI) in some patients. Because it is not possible to identify those at…”
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Mechanistic Modeling Reveals the Critical Knowledge Gaps in Bile Acid–Mediated DILI by Woodhead, JL, Yang, K, Brouwer, KLR, Siler, SQ, Stahl, SH, Ambroso, JL, Baker, D, Watkins, PB, Howell, BA

“…Bile salt export pump (BSEP) inhibition has been proposed to be an important mechanism for drug‐induced liver injury (DILI). Modeling can prioritize knowledge…”
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