Page 122 - 83_02
P. 122
M. Teresa Donato
8. Thompson RA, Isin EM, Ogese MO, et al. Reactive Handb Exp Pharmacol 2010; 196: 165-94.
Metabolites: Current and Emerging Risk and Hazard
Assessments. Chem Res Toxicol 2016; 29: 505-33. 24. Leung L, Kalgutkar AS, Obach RS. Metabolic
activation in drug-induced liver injury. Drug Metab
9. Shaw PJ, Ganey PE, Roth RA. Idiosyncratic drug-
induced liver injury and the role of inflammatory Rev 2012; 44: 18-33.
stress with an emphasis on an animal model of
trovafloxacin hepatotoxicity. Toxicol Sci 2010; 118:7- 25. Stepan AF, Walker DP, Bauman J, et al. Structural
18. alert/reactive metabolite concept as applied in
10. Yano A, Oda S, Fukami T, et al. Development of a medicinal chemistry to mitigate the risk of
cell-based assay system considering drug metabolism
and immune- and inflammatory-related factors for the idiosyncratic drug toxicity: a perspective based on the
risk assessment of drug-induced liver injury. Toxicol critical examination of trends in the top 200 drugs
Lett 2014; 228: 13-24.
marketed in the United States. Chem Res Toxicol
11. Roth RA, Ganey PE. Intrinsic versus idiosyncratic 2011; 24: 1345-410.
drug-induced hepatotoxicity--two villains or one? J
Pharmacol Exp Ther 2010; 332: 692-7. 26. Thompson RA, Isin EM, Li Y, et al. Risk assessment
and mitigation strategies for reactive metabolites in
12. Gómez-Lechón MJ, Tolosa L, Donato MT. Metabolic
activation and drug-induced liver injury: in vitro drug discovery and development. Chem Biol Interact
approaches for the safety risk assessment of new 2011; 192: 65-71.
drugs. J Appl Toxicol 2016; 36: 752-68.
27. Daly AK, Aithal GP, Leathart JB, et al. Genetic
13. Walgren JL, Mitchell MD, Thompson DC. Role of
metabolism in drug-induced idiosyncratic susceptibility to diclofenac-induced hepatotoxicity:
hepatotoxicity. Crit Rev Toxicol 2005; 5: 325-61.
contribution of UGT2B7, CYP2C8, and ABCC2
14. Gomez-Lechon MJ, Lahoz A, Gombau L, et al. In genotypes. Gastroenterology 2007; 132: 272-81.
vitro evaluation of potential hepatotoxicity induced by
drugs. Curr Pharm Des 2010; 16: 1963-77 28. Ariyoshi N, Iga Y, Hirata K, et al. Enhanced
15. Gómez-Lechón MJ, Donato MT, Castell JV, et al. susceptibility of HLA-mediated ticlopidine-induced
Human hepatocytes in primary culture: the choice to
investigate drug metabolism in man. Curr Drug Metab idiosyncratic hepatotoxicity by CYP2B6
2004; 5: 443-62. polymorphism in Japanese. Drug Metab
16. Roth RA, Ganey PE. Animal models of idiosyncratic Pharmacokinet 2010; 25: 298-306.
drug-induced liver injury--current status. Crit Rev
Toxicol 2011; 41: 723-39 29. Hawkins MT, Lewis JH. Latest advances in predicting
DILI in human subjects: focus on biomarkers. Expert
17. Uetrecht J. Idiosyncratic drug reactions: current
understanding. Annu Rev Pharmacol Toxicol 2007; Opin Drug Metab Toxicol 2012; 8: 1521-30.
47: 513-39.
30. Lucena MI, Andrade RJ, Martínez C, et al. Spanish
18. Labbe G, Pessayre D, Fromenty B. Drug-induced liver Group for the Study of Drug-Induced Liver Disease.
injury through mitochondrial dysfunction: Glutathione S-transferase m1 and t1 null genotypes
mechanisms and detection during preclinical safety
studies. Fundam Clin Pharmacol 2008; 22: 335-53. increase susceptibility to idiosyncratic drug-induced
19. Boelsterli UA, Lim PL. Mitochondrial abnormalities--a liver injury. Hepatology 2008; 48: 588-96.
link to idiosyncratic drug hepatotoxicity? Toxicol
Appl Pharmacol 2007; 220: 92-107. 31. Lucena MI, García-Martín E, Andrade RJ, et al.
Mitochondrial superoxide dismutase and glutathione
20. Han D, Dara L, Win S, et al. Regulation of drug-
induced liver injury by signal transduction pathways: peroxidase in idiosyncratic drug-induced liver injury.
critical role of mitochondria. Trends Pharmacol Sci
2013; 34: 243-53. Hepatology. 2010; 52: 303-12.
21. Lammert C, Bjornsson E, Niklasson A, et al. Oral 32. Andrade R. Hepatopatía inducida por fármacos. XIX
medications with significant hepatic metabolism at Curso de Postgrado AGA-SEPD. Semana de las
higher risk for hepatic adverse events. Hepatology
2010; 51: 615-20. Enfermedades Digestivas, Bilbao, 2-5 Junio 2012;
22. Kalgutkar AS, Soglia JR. Minimising the potential for pp.52-7. Disponible en:
metabolic activation in drug discovery. Expert Opin
Drug Metab Toxicol 2005; 1: 91-142. (https://www.sepd.es/pdf/SED2012-Curso %20AGA
23. Srivastava A, Maggs JL, Antoine DJ, et al. Role of %20SEPD.pdf)
reactive metabolites in drug-induced hepatotoxicity.
33. Godoy P, Hewitt NJ, Albrecht U, et al. Recent
282 advances in 2D and 3D in vitro systems using primary
hepatocytes, alternative hepatocyte sources and non-
parenchymal liver cells and their use in investigating
mechanisms of hepatotoxicity, cell signaling and
ADME. Arch Toxicol 2013; 87: 1315-530.
34. Gomez-Lechon MJ, Tolosa L, Conde I, et al.
Competency of different cell models to predict human
hepatotoxic drugs. Expert Opin Drug Metab Toxicol
2014; 10: 1553-68.
35. Sarkar U, Rivera-Burgos D, Large EM, et al.
Metabolite profiling and pharmacokinetic evaluation
of hydrocortisone in a perfused three-dimensional
human liver bioreactor. Drug Metab Dispos 2015; 43:
1091-9.
@Real Academia Nacional de Farmacia. Spain