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Advances in the development and use of human tissue-based techniques for drug toxicity testing

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Pages 1155-1169 | Published online: 20 May 2013

Bibliography

  • Arrowsmith J. Trial watch: phase III and submission failures: 2007 – 2010. Nat Rev Drug Discov 2011;10(2):87
  • Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004;3(8):711-15
  • Available from: www.imi-safe-t.eu [Last accessed 3 January 2013]
  • Sun H, Xia M, Austin CP, et al. Paradigm shift in toxicity testing and modeling. AAPS J 2012;14(3):473-80
  • Goldman M, Compton C, Mittleman BB. Public-private partnerships as driving forces in the quest for innovative medicines. Clin Transl Med 2013;2(1):2
  • van Meer PJ, Kooijman M, Gispen-de Wied CC, et al. The ability of animal studies to detect serious post marketing adverse events is limited. Regul Toxicol Pharmacol 2012;64(3):345-9
  • Seok J, Warren HS, Cuenka AG, et al. Genomic responses in mouse models poorly mimic human inflammatory diseases. Proc Natl Acad Sci USA 2013;110(9):3507-12
  • Abraham T, Kayra D, McManus B, Scott A. Quantitative assessment of forward and backward second harmonic three dimensional images of collagen Type I matrix remodeling in a stimulated cellular environment. J Struct Biol 2012;180(1):17-25
  • Pagliari S, Vilela-Silva AC, Forte G, et al. Cooperation of biological and mechanical signals in cardiac progenitor cell differentiation. Adv Mater 2011;23(4):514-18
  • Lee KS, Zhou W, Scott-McKean JJ, et al. Human sensory neurons derived from induced pluripotent stem cells support varicella-zoster virus infection. PLoS One 2012;7(12):e53010
  • Kinnear C, Chang WY, Khattak S, et al. Modeling and Rescue of the Vascular Phenotype of Williams-Beuren Syndrome in Patient Induced Pluripotent Stem Cells. Stem Cells Transl Med 2012; Epub ahead of print
  • Astashkina A, Mann B, Grainger DW. A critical evaluation of in vitro cell culture models for high-throughput drug screening and toxicity. Pharmacol Ther 2012;134(1):82-106
  • Lee WM, Squires RH Jr, Nyberg SL, et al. Acute liver failure: summary of a workshop. Hepatology 2008;47(4):1401-15
  • Kaplowitz N. Idiosyncratic drug hepatotoxicity. Nat Rev Drug Discov 2005;4(6):489-99
  • Jaeschke H, et al. Mechanisms of hepatotoxicity. Toxicol Sci 2002;65(2):166-76
  • Dykens J, Will Y. Drug-induced mitochondrial dysfunction. John Wiley and Sons, Hoboken, New Jersey; 2008
  • Xu JJ, et al. Predicting Drug-Induced Hepatotoxicity. In: Urban BFAL, editor. In vitro, in silico and in vivo approaches, in hit and lead profiling. WILEY-VCH, Weinheim, Germany; 2009. p. 345-85
  • LeCluyse EL, Witek RP, Andersen ME, et al. Organotypic liver culture models: meeting current challenges in toxicity testing. Crit Rev Toxicol 2012;42(6):501-48
  • Mazzoleni G, Steimberg N. New models for the in vitro study of liver toxicity: 3D culture systems and the role of bioreactors. Chapter. In: Tyshenko MG, editor. The continuum of health risk assessments. ISBN 980-953-307-582-7: InTech (Open Access Publishing), 2012
  • Meng Q. Three-dimensional culture of hepatocytes for prediction of drug-induced hepatotoxicity. Expert Opin Drug Metab Toxicol 2010;6(6):733-46
  • Curtis CG, Bilyard K, Stephenson H. Ex Vivo Metrics™, a preclinical tool in new drug development. J Transl Med 2008;6:5
  • Brandon EFA, Raap CD, Meijerman I, et al. An update on in vitro test methods in human hepatic drug biotransformation research: pros and cons. Toxicol Appl Pharmacol 2003;189:233-46
  • Olinga P, Groothuis GMM. Use of human tissue slices in drug targeting research. In: Molema G, Meijer DKF, editors. Drugtargeting: organ specific strategies. Wiley-VCH, Weinheim; 2001. p. 309-31
  • Van de Bovenkamp M, Groothuis GM, Meijer DK, Olinga P. Liver fibrosis in vitro: Cell culture models and precision-cut liver slices. Toxicol In Vitro 2007;21:545-57
  • Van de Bovenkamp M, Groothuis GM, Meijer DK, et al. Human liver slices as an in vitro model to study toxicity-induced hepatic stellate cell activation in a multicellular milieu. Chem Biol Interact 2006;162:62-9
  • Elferink MGL, Olinga P, van Leeuwen EM, et al. Gene expression analysis of precision-cut human liver slices indicates stable expression of ADME-Tox related genes. Toxicol Appl Pharmacol 2011;253:57-69
  • Khan AA, Chow CCY, Porte RJ, et al. The role of lithocholic acid in the regulation of bile acid detoxication, synthesis, and transport proteins in rat and human intestine and liver slices. Toxicol In Vitro 2011;25(1):80-90
  • Elferink MGL, Olinga P, Draaisma AL, et al. LPS-induced downregulation of MRP2 and BSEP in human liver is due to a posttranscriptional process. J Physiol Gastrointest Liver Physiol 2004;287:G1008-16
  • Plazar J, Hreljac I, Pirih P, et al. Detection of xenobiotic-induced DNA damage by the comet assay applied to human and rat precision-cut liver slices. Toxicol In Vitro 2007;21(6):1134-42
  • Hadi M, Dragovic S, van Swelm R, et al. AMAP, the alleged non-toxic isomer of acetaminophen, is toxic in rat and human liver. Arch Toxicol 2012; Epub ahead of print
  • Vinci B, Duret C, Klieber S, et al. Modular bioreactor for primary human hepatocyte culture: medium flow stimulates expression and activity of detoxification genes. Biotechnol J 2011;6:554-64
  • Wang Y, Cui CB, Yamauchi M, et al. Lineage restriction of human hepatic stem cells to mature fates is made efficient by tissue-specific biomatrix scaffolds. Hepatology 2011;53:293-305
  • Swift B, Pfeifer ND, Brouwer KL. Sandwich-cultured hepatocytes: an in vitro model to evaluate hepatobiliary transporter-based drug interactions and hepatotoxicity. Drug Metab Rev 2010;42(3):446-71
  • McIntosh MB, Corner SM, Amiot BP, et al. Engineering analysis and development of the spheroid reservoir bioartificial liver. Conf Proc IEEE Eng Med Biol Soc 2009;2009:5985-8
  • Tostões RM, Leite SB, Miranda JP, et al. Perfusion of 3D encapsulated hepatocytes--a synergistic effect enhancing long-term functionality in bioreactors. Biotechnol Bioeng 2011;108(1):41-9
  • Novik E, Maguire TJ, Chao P, et al. A microfluidic hepatic coculture platform for cell-based drug metabolism studies. Biochem Pharmacol 2010;79(7):1036-44
  • Khetani SR, Bhatia SN. Microscale culture of human liver cells for drug development. Nature Biotechnology 2008;26:120-6
  • WeiWei Wang W, Khetani SR, Krzyzewski S, et al. Assessment of a micropatterned hepatocyte coculture system to generate major human excretory and circulating drug metabolites. Drug Metab Dispos 2010;38(10):900-1905
  • Goyal RK, Hirano I. The enteric nervous system. New Engl J Med 1996;334:1106-15
  • Wei Y, Neves LA, Franklin T, et al. Vascular perfused segments of human intestine as a tool for drug absorption. Drug Metab Dispos 2009;37(4):731-6
  • Broad J, Mukherjee S, Samadi M, et al. Regional- and agonist-dependent facilitation of human neurogastrointestinal functions by motilin receptor agonists. Br J Pharmacol 2012;167(4):763-74
  • van de Kerkhof EG, Ungell AL, Sjoberg AK, et al. Innovative methods to study human intestinal drug metabolism in vitro: precision-cut slices compared with ussing chamber preparations. Drug Metab Dispos 2006;34:1893-902
  • Li M, Si LQ, Pan HP, et al. Excipients enhance intestinal absorption of ganciclovir by P-gp inhibition: Assessed in vitro by everted gut sac and in situ by improved intestinal perfusion. Int J Pharm 2011;403:7-45
  • Alam MA, Al-Jenoobi FI, Al-Mohizea AM. Everted gut sac model as a tool in pharmaceutical research: limitations and applications. J Pharm Pharmacol 2012;64(3):326-36
  • Randall KJ, Turton J, Foster JR. Explant culture of gastrointestinal tissue: a review of methods and applications. Cell Biol Toxicol 2011;27:267-84
  • Groothuis GMM, de Graaf IAM. Precision-cut intestinal slices as in vitro tool for studies on drug metabolism. Curr Drug Metabol 2013;14(8):112-19
  • Kim HJ, Huh D, Hamilton G, et al. Human gut-on-a-chip inhabited by microbial flora that experiences intestinal peristalsis-like motions and flow. Lab Chip 2012;12(12):2165-74
  • Gharib SA, Nguyen E, Altemeier WA, et al. Of mice and men: comparative proteomics of bronchoalveolar fluid. Eur Respir J 201;35(6):1388-95
  • Frank JA, Briot R, Lee JW, et al. Physiological and biochemical markers of alveolar epithelial barrier dysfunction in perfused human lungs. Am J Physiol Lung Cell Mol Physiol 2007;293(1):L52-9
  • Cypel M, Yeung JC, Hirayama S, et al. Technique for prolonged normothermic ex vivo lung perfusion. J Heart Lung Transplant 2008;27:1319-25
  • Cypel M, Rubacha M, Yeung J, et al. Normothermic ex vivo perfusion prevents lung injury compared to extended cold preservation for transplantation. Am J Transplant 2009;9:2262-9
  • Steen S, Ingemansson R, Eriksson L, et al. First human transplantation of a nonacceptable donor lung after reconditioning ex vivo. Ann Thorac Surg 2007;83(6):2191-4
  • Switalla S, Lauenstein L, Prenzler F, et al. Natural innate cytokine response to immunomodulators and adjuvants in human precision-cut lung slices. Toxicol Appl Pharmacol 2010(246):107-15
  • Sewald K, Braun A. Assessment of immunotoxicity using precision-cut tissue slices. Xenobiotica 2013;43(1):84-97
  • BéruBé K, Prytherch Z, Job C, et al. Human primary bronchial lung cell constructs: the new respiratory models. Toxicology 2010;278(3):311-18
  • Huang S, Wiszniewski L, Constant S. The use of in vitro 3d cell models in drug development for respiratory diseases. Chapter 8. In: Kapetanovic IM, editor. Drug discovery and development- present and future. ISBN 978-953-307-615-7: InTech (Open Access Publishing), 2011. p. 169-90
  • Sexton K, Balharry D, Brennan P, et al. Proteomic profiling of human respiratory epithelia by iTRAQ reveals biomarkers of exposure and harm by tobacco smoke components. Biomarkers 2011;16(7):567-76
  • Richter PA, Li AP, Polzin G, Roy SK. Cytotoxicity of eight cigarette smoke condensates in three test systems: comparisons between assays and condensates. Regul Toxicol Pharmacol 2010;58(3):428-36
  • Li AP. The Use of the Integrated Discrete Multiple Organ Coculture (IdMOC®) system for the evaluation of multiple organ toxicity. ATLA 2009;37:377-85
  • Huh D, Matthews BD, Mammoto A, et al. Reconstituting organ-level lung functions on a chip. Science 2010;328(5986):1662-8
  • Huh D, Leslie DC, Matthews BD, et al. A human disease model of drug toxicity–induced pulmonary edema in a lung-on-a-chip microdevice. Sci Transl Med 2012;4:159ra147
  • Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. U. S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research February 28, 1997
  • Stebbings R, Findlay L, Edwards C, et al. “Cytokine storm” in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J Immunol 2007;179:3325-31
  • Cupedo T, Stroock A, Coles M. Application of tissue engineering to the immune system: development of artifical lymph nodes. Front Immun 2012;3:343
  • Kobayashi Y, Kato K, Watanabe T. Synthesis of functional artificial lymphoid tissues. Discov Med 2011;12:351-62
  • Higbee RG, Byers AM, Dhir V, et al. An immunologic model for rapid vaccine assessment -- a clinical trial in a test tube. Altern Lab Anim 2009;37(Suppl 1):19-27
  • Caspi O, Itzhaki I, Kehat I, et al. In Vitro Electrophysiological Drug Testing Using Human Embryonic Stem Cell Derived Cardiomyocytes. Stem Cells Dev 2009;18(1):161-72
  • Barth AS, Zhang Y, Li T, et al. Functional impairment of human resident cardiac stem cells by the cardiotoxic antineoplastic agent trastuzumab. Stem Cells Transl Med 2012;1(4):289-97
  • Fedele C, Riccio G, Coppola C, et al. Comparison of preclinical cardiotoxic effects of different ErbB2 inhibitors. Breast Cancer Res Treat 2012;133(2):511-21
  • Franchini JL, Propst JT, Comer GR, et al. Novel tissue engineered tubular heart tissue for in vitro pharmaceutical toxicity testing. Microsc Microanal 2007;13(4):267-71
  • Xu T, Baicu C, Aho M, et al. Fabrication and characterization of bio-engineered cardiac pseudo tissues. Biofabrication 2009;1(3):035001
  • Hill AJ, Laske TG, Coles JA Jr, et al. In vitro studies of human hearts. Ann Thorac Surg 2005;79(1):168-77
  • Fenichel RR, Malik M, Antzelevitch C, et al. Drug-Induced Torsade de Pointes and Implications for Drug Development. J Cardiovasc Electrophysiol 2004;15(4):475-95
  • Zwi L, Caspi O, Arbel G, et al. Cardiomyocyte Differentiation of Human Induced Pluripotent Stem Cells. Circulation 2009;120:1513-23
  • Itzhaki I, Maizels L, Huber I, et al. Modelling the long QT syndrome with induced pluripotent stem cells. Nature 2011;471(7337):225-9
  • Moretti A, Bellin M, Welling A, et al. Patient-specific induced pluripotent stem-cell models for long-QT syndrome. Engl J Med 2010;363(15):1397-409
  • Nguemo F, Šarić T, Pfannkuche K, et al. In vitro model for assessing arrhythmogenic properties of drugs based on high-resolution impedance measurements. Cell Physiol Biochem 2012;29(5-6):819-32
  • Cerignoli F, Charlot D, Whittaker R, et al. High throughput measurement of Ca(2+) dynamics for drug risk assessment in human stem cell-derived cardiomyocytes by kinetic image cytometry. J Pharmacol Toxicol Methods 2012;66(3):246-56
  • Moss E, Lynagh S, Smith D, et al. A novel system for the investigation of microvascular dysfunction including vascular permeability and flow-mediated dilatation in pressurised human arteries. J Pharmacol Toxicol Methods 2010;62(1):40-6
  • East E, Phillips JB. Tissue engineered cell culture models for nervous system research. In: Greco GN, editor. Tissue engineering research trends. 978-1-60456-264-4: Nova Science Publishers, Inc, Hauppage, New York; 2008. p. 141-60
  • Root J, Wakenhut AM, Siggins H, et al. Opioid receptor characterisation of neuronally stimulated isolated human vas deferens. Naunyn Schmiedebergs Arch Pharmacol 2012;385(11):1049-52
  • Cunningham MO, Roopun A, Schofield IS, et al. Glissandi: transient fast electrocorticographic oscillations of steadily increasing frequency, explained by temporally increasing gap junction conductance. Epilepsia 2012;53(7):1205-14
  • Haidet-Phillips AM, Hester ME, Miranda CJ, et al. Astrocytes from familial and sporadic ALS patients are toxic to motor neurons. Nat Biotechnol 2011;29(9):824-8
  • East E, Phillips JB. Engineering an integrated cellular interface in three-dimensional hydrogel cultures permits monitoring of reciprocal astrocyte and neuronal responses. Tissue Engi Part C Methods 2012;18(7):526-36
  • Wright KE, MacRobert AJ, Phillips JB. Inhibition of specific cellular antioxidant pathways increases the sensitivity of neurons to meta-tetrahydroxyphenyl chlorin-mediated photodynamic therapy in a 3D co-culture model. Photochem Photobiol 2012;88(6):1539-45
  • Teeling-Smith G. A question of balance; the benefits and risks of pharmaceutical innovation. Office of Health Economics, London, UK; 1980. p. 29
  • Knobloch J, Reimann K, Klotz LO, Rüther U. Thalidomide resistance is based on the capacity of the glutathione-dependent antioxidant defense. Mol Pharm 2008;5(6):1138-44
  • Monaco MC, Maric D, Bandeian A, et al. Progenitor-derived oligodendrocyte culture system from human fetal brain. J Vis Exp 2012;70):4274
  • Balmer NV, Weng MK, Zimmer B, et al. Epigenetic changes and disturbed neural development in a human embryonic stem cell-based model relating to the fetal valproate syndrome. Hum Mol Genet 2012;21(18):4104-14
  • Schreiber T, Gassmann K, Götz C, et al. Polybrominated diphenyl ethers induce developmental neurotoxicity in a human in vitro model: evidence for endocrine disruption. Environ Health Perspect 2010;118(4):572-8
  • Stiegler NV, Krug AK, Matt F, Leist M. Assessment of chemical-induced impairment of human neurite outgrowth by multiparametric live cell imaging in high-density cultures. Toxicol Sci 2011;121(1):73-87
  • Brieño-Enríquez MA, Reig-Viader R, Cabero L, et al. Gene expression is altered after bisphenol A exposure in human fetal oocytes in vitro. Mol Hum Reprod 2012;18(4):171-83
  • Brieño-Enríquez MA, Robles P, Camats-Tarruella N, et al. Human meiotic progression and recombination are affected by Bisphenol A exposure during in vitro human oocyte development. Hum Reprod 2011;26(10):2807-18
  • Papadimitropoulos A, Scherberich A, Güven S, et al. A 3D in vitro bone organ model using human progenitor cells. Eur Cell Mater 2011;21:445-58. discussion 458
  • Parker BA, Capizzi JA, Grimaldi AS, et al. Effect of statins on skeletal muscle function. Circulation 2013;127(1):96-103
  • Knauer MJ, Urquhart BL, Meyer zu Schwabedissen HE, et al. Human skeletal muscle drug transporters determine local exposure and toxicity of statins. Circ Res 2010;106(2):297-306
  • Sharples AP, Player DJ, Martin NR, et al. Modelling in vivo skeletal muscle ageing in vitro using three-dimensional bioengineered constructs. Aging Cell 2012;11(6):986-95
  • Hayashi K, Mori T, Abo T, et al. Two-stage bottom-up tiered approach combining several alternatives for identification of eye irritation potential of chemicals including insoluble or volatile substances. Toxicol In Vitro 2012;26(7):1199-208
  • Forsby A, Norman KG, El Andaloussi-Lilja J, et al. Using novel in vitro NociOcular assay based on TRPV1 channel activation for prediction of eye sting potential of baby shampoos. Toxicol Sci 2012;129(2):325-31
  • Paquet C, Larouche D, Bisson F, et al. Tissue engineering of skin and cornea: development of new models for in vitro studies. Ann NY Acad Sci 2010;1197:166-77
  • Mehling A, Eriksson T, Eltze T, et al. Non-animal test methods for predicting skin sensitization potentials. Arch Toxicol 2012;86(8):1273-95
  • Luebke R. Immunotoxicant screening and prioritization in the twenty-first century. Toxicol Pathol 2012;40(2):294-9
  • Sarmento B, Andrade F, da Silva SB, et al. Cell-based in vitro models for predicting drug permeability. Expert Opin Drug Metab Toxicol 2012;8(5):607-21
  • Li AP, Bode C, Sakai Y. A novel in vitro system, the integrated discrete multiple organ cell culture (IdMOC) system, for the evaluation of human drug toxicity: comparative cytotoxicity of tamoxifen towards normal human cells from five major organs and MCF-7 adenocarcinoma breast cancer cells. Chem Biol Interact 2004;150(1):129-36
  • Li AP. The Use of the Integrated Discrete Multiple Organ Coculture (IdMOC®) System for the Evaluation of Multiple Organ Toxicity. ATLA 37, 377–385, 2009. Regul Toxicol Pharmacol 2010;58(3):428-36
  • Neuži P, Giselbrecht S, Länge K, et al. Revisiting lab-on-a-chip technology for drug discovery. Nat Rev Drug Discov 2012;11(8):620-32
  • Clotworthy M. The application of human tissue for drug discovery and development. Expert Opin Drug Discov 2012;7(7):543-7
  • Toxicity Testing in the 21st Century, a Vision and a Strategy. Committee on Toxicity Testing and Assessment of Environmental Agents, National Research Council (2007). Andersen ME, Krewski D. Toxicity testing in the 21st century: bringing the vision to life. Toxicol Sci 2009;107(2):324-30
  • Coleman RA. Human tissue in the evaluation of safety and efficacy of new medicines: a viable alternative to animal models? ISRN Pharm 2011;2011:806789
  • Varki NM, Strobert E, Dick EJ Jr, et al. Biomedical differences between human and nonhuman hominids: potential roles for uniquely human aspects of sialic acid biology. Annu Rev Pathol 2011;6:365-93
  • Johnson JI, Decker S, Zaharevitz D, et al. Relationships between drug activity in NCI preclinical in vitro and in vivo models an early clinical trials. Br J Cancer 2001;84:1424-31
  • Voskoglou-Nomikos T, Pater JL, Seymour L. Clinical predictive value of the in vitro cell line, human xenograft, and mouse allograft preclinical cancer models. Clin Cancer Res 2003;9:4227-39
  • Haddad TC, Yee D. Of mice and (wo)men: is this any way to test a new drug? J Clin Oncol 2008 Feb 20;26(6):830-2
  • Sausville EA, Burger AM. Contributions of human tumor xenografts to anticancer drug development. Cancer Res 2006 Apr 1;66(7):3351-4. discussion 3354
  • Available from: http://tissueforresearch.com/available-tissues.html [Accessed 4 January 2013]

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