Translating in vitro to in vivo and animal to human

Beilmann, 2019, Optimizing drug discovery by investigative toxicology: current and future trends, ALTEX, 36, 289 Marx, 2016, Biology-inspired microphysiological system approaches to solve the prediction dilemma of substance testing, ALTEX, 33, 272 Chen, 2015, Drug-induced liver injury: interactions between drug properties and host factors, J Hepatol, 63, 503, 10.1016/j.jhep.2015.04.016 Funk, 2017, Current limitations and future opportunities for prediction of DILI from in vitro, Arch Toxicol, 91, 131, 10.1007/s00204-016-1874-9 Raschi, 2019, Strategies for early prediction and timely recognition of drug-induced liver injury: the case of cyclin-dependent kinase 4/6 inhibitors, Front Pharmacol, 10, 1235, 10.3389/fphar.2019.01235 2005 Baudy, 2020, Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry, Lab Chip, 20, 215, 10.1039/C9LC00768G Chen, 2013, High lipophilicity and high daily dose of oral medications are associated with significant risk for drug-induced liver injury, Hepatology, 58, 388, 10.1002/hep.26208 Schadt, 2015, Minimizing DILI risk in drug discovery - a screening tool for drug candidates, Toxicol Vitro, 30, 429, 10.1016/j.tiv.2015.09.019 Shah, 2015, Setting clinical exposure levels of concern for drug-induced liver injury (DILI) using mechanistic in vitro assays, Toxicol Sci, 147, 500, 10.1093/toxsci/kfv152 Thompson, 2012, In vitro approach to assess the potential for risk of idiosyncratic adverse reactions caused by candidate drugs, Chem Res Toxicol, 25, 1616, 10.1021/tx300091x Jang, 2019, Reproducing human and cross-species drug toxicities using a liver-chip, Sci Transl Med, 11, 10.1126/scitranslmed.aax5516 Proctor, 2017, Utility of spherical human liver microtissues for prediction of clinical drug-induced liver injury, Arch Toxicol, 91, 2849, 10.1007/s00204-017-2002-1 Vorrink, 2018, Prediction of drug-induced hepatotoxicity using long-term stable primary hepatic 3D spheroid cultures in chemically defined conditions, Toxicol Sci, 163, 655, 10.1093/toxsci/kfy058 Ware, 2015, Prediction of drug-induced liver injury in micropatterned co-cultures containing iPSC-derived human hepatocytes, Toxicol Sci, 145, 252, 10.1093/toxsci/kfv048 Ware, 2018, A cell culture platform to maintain long-term phenotype of primary human hepatocytes and endothelial cells, Cell Mol Gastroenterol Hepatol, 5, 187, 10.1016/j.jcmgh.2017.11.007 Yu, 2017, A perfusion incubator liver chip for 3D cell culture with application on chronic hepatotoxicity testing, Sci Rep, 7, 14528, 10.1038/s41598-017-13848-5 Yoon, 2015, Quantitative in vitro to in vivo extrapolation (QIVIVE): an essential element for in vitro-based risk assessment, Toxicology, 332, 1, 10.1016/j.tox.2015.02.002 Albrecht, 2019, Prediction of human drug-induced liver injury (DILI) in relation to oral doses and blood concentrations, Arch Toxicol, 93, 1609, 10.1007/s00204-019-02492-9 Sanz, 2017, Legacy data sharing to improve drug safety assessment: the eTOX project, Nat Rev Drug Discov, 16, 811, 10.1038/nrd.2017.177 Steger-Hartmann, 2018, Improving the safety assessment of chemicals and drug candidates by the integration of bioinformatics and chemoinformatics data, Basic Clin Pharmacol Toxicol, 123, 29, 10.1111/bcpt.12956 Ramaiahgari, 2019, Organotypic 3D HepaRG liver model for assessment of drug-induced cholestasis, Methods Mol Biol, 1981, 313, 10.1007/978-1-4939-9420-5_20 Tascher, 2019, In-depth proteome analysis highlights HepaRG cells as a versatile cell system surrogate for primary human hepatocytes, Cells, 8, 10.3390/cells8020192 Tolosa, 2019, Long-term and mechanistic evaluation of drug-induced liver injury in Upcyte human hepatocytes, Arch Toxicol, 93, 519, 10.1007/s00204-018-2349-y Sison-Young, 2017, A multicenter assessment of single-cell models aligned to standard measures of cell health for prediction of acute hepatotoxicity, Arch Toxicol, 91, 1385, 10.1007/s00204-016-1745-4 Rayner, 2019, Optimization of normal human bronchial epithelial (NHBE) cell 3D cultures for in vitro lung model studies, Sci Rep, 9, 500, 10.1038/s41598-018-36735-z Peters, 2019, Human 3D gastrointestinal microtissue barrier function as a predictor of drug-induced diarrhea, Toxicol Sci, 168, 3, 10.1093/toxsci/kfy268 Gholobova, 2018, Human tissue-engineered skeletal muscle: a novel 3D in vitro model for drug disposition and toxicity after intramuscular injection, Sci Rep, 8, 12206, 10.1038/s41598-018-30123-3 Bauer, 2017, Functional coupling of human pancreatic islets and liver spheroids on-a-chip: towards a novel human ex vivo type 2 diabetes model, Sci Rep, 7, 14620, 10.1038/s41598-017-14815-w Worsdorfer, 2019, Generation of complex human organoid models including vascular networks by incorporation of mesodermal progenitor cells, Sci Rep, 9, 15663, 10.1038/s41598-019-52204-7 Belair, 2017, Engineering epithelial-stromal interactions in vitro for toxicology assessment, Toxicology, 382, 93, 10.1016/j.tox.2017.03.007 Bell, 2018, Comparison of hepatic 2D sandwich cultures and 3D spheroids for long-term toxicity applications: a multicenter study, Toxicol Sci, 162, 655, 10.1093/toxsci/kfx289 Natale, 2019, Technological advancements for the development of stem cell-based models for hepatotoxicity testing, Arch Toxicol, 93, 1789, 10.1007/s00204-019-02465-y Rouquie, 2014, Thyroid tumor formation in the male mouse induced by fluopyram is mediated by activation of hepatic CAR/PXR nuclear receptors, Regul Toxicol Pharmacol, 70, 673, 10.1016/j.yrtph.2014.10.003 Kühnlenz, 2019, P24-017: establishment of a multi-organ-chip based identification platform for endocrine disruptors Böhm, 2019, P24-020: development of a rodent liver-thyroid-2-organ-chip for thyroid toxicity testing, 294 Guardiola, 2019, A third shot at EGFR: new opportunities in cancer therapy, Trends Pharmacol Sci, 40, 941, 10.1016/j.tips.2019.10.004 Hubner, 2018, Simultaneous evaluation of anti-EGFR-induced tumour and adverse skin effects in a microfluidic human 3D co-culture model, Sci Rep, 8, 15010, 10.1038/s41598-018-33462-3 Desnoyers, 2013, Tumor-specific activation of an EGFR-targeting probody enhances therapeutic index, Sci Transl Med, 5, 10.1126/scitranslmed.3006682 McAleer, 2019, Multi-organ system for the evaluation of efficacy and off-target toxicity of anticancer therapeutics, Sci Transl Med, 11, 10.1126/scitranslmed.aav1386 Olson, 2000, Concordance of the toxicity of pharmaceuticals in humans and in animals, Regul Toxicol Pharmacol, 32, 56, 10.1006/rtph.2000.1399 Clark, 2018, A big data approach to the concordance of the toxicity of pharmaceuticals in animals and humans, Regul Toxicol Pharmacol, 96, 94, 10.1016/j.yrtph.2018.04.018 2001 Paglialunga, 2019, Translatability of the S7A core battery respiratory safety pharmacology studies: preclinical respiratory and related clinical adverse events, J Pharmacol Toxicol Methods, 99, 106596, 10.1016/j.vascn.2019.106596 Li, 2018, Evaluation of drug-induced liver injuries (DILI) with human hepatocytes: scientific rationale and experimental approaches, 179 Watkins, 2019, The DILI-sim initiative: insights into hepatotoxicity mechanisms and biomarker interpretation, Clin Transl Sci, 12, 122, 10.1111/cts.12629