메뉴 건너뛰기




Volumn 2, Issue 3, 2007, Pages 193-199

Human-based in vitro experimental systems for the evaluation of human drug safety

Author keywords

[No Author keywords available]

Indexed keywords

9 AMINOCAMPTOTHECIN; ALCOHOL; AMINEPTINE; CADMIUM CHLORIDE; CAMPTOTHECIN; CHLORZOXAZONE; CISPLATIN; COCAINE; COUMARIN; CYCLOPHOSPHAMIDE; CYTOCHROME P450; CYTOCHROME P450 1A1; CYTOCHROME P450 1A2; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; CYTOCHROME P450 3A7; ERYTHROMYCIN; HALOTHANE; IMIPRAMINE; ISAXONINE; MEPHENYTOIN; METHYLDOPA; NEW DRUG; PARACETAMOL; PHENYTOIN; TESTOSTERONE; TIENILIC ACID; TOLBUTAMIDE; TOPOTECAN; UNINDEXED DRUG;

EID: 35348893768     PISSN: 15748863     EISSN: None     Source Type: Journal    
DOI: 10.2174/157488607781668909     Document Type: Review
Times cited : (15)

References (33)
  • 1
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003; 22(2): 151-85.
    • (2003) J Health Econ , vol.22 , Issue.2 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 2
    • 0035897708 scopus 로고    scopus 로고
    • A comparison of aroclor 1254-induced and uninduced rat liver microsomes to human liver microsomes in phenytoin O-deethylation, coumarin 7-hydroxylation, tolbutamide 4-hydroxylation, S-mephenytoin 4′-hydroxylation, chloroxazone 6-hydroxylation and testosterone 6beta-hydroxylation
    • Easterbrook J, Fackett D, Li AP. A comparison of aroclor 1254-induced and uninduced rat liver microsomes to human liver microsomes in phenytoin O-deethylation, coumarin 7-hydroxylation, tolbutamide 4-hydroxylation, S-mephenytoin 4′-hydroxylation, chloroxazone 6-hydroxylation and testosterone 6beta-hydroxylation. Chem Biol Interact 2001; 134(3): 243-9.
    • (2001) Chem Biol Interact , vol.134 , Issue.3 , pp. 243-249
    • Easterbrook, J.1    Fackett, D.2    Li, A.P.3
  • 3
    • 0031054593 scopus 로고    scopus 로고
    • Differential toxicity of camptothecin, topotecan and 9-aminocamptothecin to human, canine, and murine myeloid progenitors (CFU-GM) in vitro
    • Erickson-Miller CL, May RD, Tomaszewski J, et al. Differential toxicity of camptothecin, topotecan and 9-aminocamptothecin to human, canine, and murine myeloid progenitors (CFU-GM) in vitro. Cancer Chemother Pharmacol 1997; 39(5): 467-72.
    • (1997) Cancer Chemother Pharmacol , vol.39 , Issue.5 , pp. 467-472
    • Erickson-Miller, C.L.1    May, R.D.2    Tomaszewski, J.3
  • 4
    • 0033306846 scopus 로고    scopus 로고
    • Assessment of the quality and quantity of drug-drug interaction studies in recent NDA submissions: Study design and data analysis issues
    • Huang SM, Lesko LJ, William RL. Assessment of the quality and quantity of drug-drug interaction studies in recent NDA submissions: study design and data analysis issues. J Clin Pharmacol 1999; 39(10): 1006-14.
    • (1999) J Clin Pharmacol , vol.39 , Issue.10 , pp. 1006-1014
    • Huang, S.M.1    Lesko, L.J.2    William, R.L.3
  • 5
    • 0033323809 scopus 로고    scopus 로고
    • FDA evaluations using in vitro metabolism to predict and interpret in vivo metabolic drug-drug interactions: Impacit on labeling
    • Davit B, Reynolds K, Yuan R, et al. FDA evaluations using in vitro metabolism to predict and interpret in vivo metabolic drug-drug interactions: impacit on labeling. J Clin Pharmacol 1999; 39(9): 899-910.
    • (1999) J Clin Pharmacol , vol.39 , Issue.9 , pp. 899-910
    • Davit, B.1    Reynolds, K.2    Yuan, R.3
  • 6
    • 2342512256 scopus 로고    scopus 로고
    • In vitro approaches to evaluate ADMET drug properties
    • Li, AP. In vitro approaches to evaluate ADMET drug properties. Curr Top Med Chem 2004a; 4(7): 701-6.
    • (2004) Curr Top Med Chem , vol.4 , Issue.7 , pp. 701-706
    • Li, A.P.1
  • 7
    • 35348845043 scopus 로고    scopus 로고
    • FDA (1997). Drug Metabolism/Drug Interaction Studies in the Drug Development Process: 'Studies In Vitro (Issued 4/1997, Posted 4/8/ 1997). http://www.fda.gov/cder/guidance/clin3.pdf.
    • FDA (1997). Drug Metabolism/Drug Interaction Studies in the Drug Development Process: 'Studies In Vitro (Issued 4/1997, Posted 4/8/ 1997). http://www.fda.gov/cder/guidance/clin3.pdf.
  • 8
    • 35348832177 scopus 로고    scopus 로고
    • FDA (1999). In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (Issued 11/24/1999, Posted 11/24/1999). http://www.fda.gov/cder/guidance/ 2635fnl.pdf.
    • (a) FDA (1999). In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (Issued 11/24/1999, Posted 11/24/1999). http://www.fda.gov/cder/guidance/ 2635fnl.pdf.
  • 9
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • (b) Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004; 3: 711-715.
    • (2004) Nat Rev Drug Discov , vol.3 , pp. 711-715
    • Kola, I.1    Landis, J.2
  • 10
    • 17744385960 scopus 로고    scopus 로고
    • In vitro human tissue models in risk assessment: Report of a consensus-building workshop
    • MacGregor JT, Collins JM, Sugiyama Y, et al. In vitro human tissue models in risk assessment: report of a consensus-building workshop. Toxicol Sci 2001; 59(1): 17-36.
    • (2001) Toxicol Sci , vol.59 , Issue.1 , pp. 17-36
    • MacGregor, J.T.1    Collins, J.M.2    Sugiyama, Y.3
  • 11
    • 0032968777 scopus 로고    scopus 로고
    • Cryopreserved human hepatocytes: Characterization of drug-metabolizing enzyme activities and applications in higher throughput screening assays for hepatotoxicity, metabolic stability, and drug-drug interaction potential
    • Li AP, Lu C, Brent JA, et al. Cryopreserved human hepatocytes: characterization of drug-metabolizing enzyme activities and applications in higher throughput screening assays for hepatotoxicity, metabolic stability, and drug-drug interaction potential. Chem Biol Interact 1999; 121(1): 17-35.
    • (1999) Chem Biol Interact , vol.121 , Issue.1 , pp. 17-35
    • Li, A.P.1    Lu, C.2    Brent, J.A.3
  • 12
    • 0037310871 scopus 로고    scopus 로고
    • Inhibition of transporter-mediated hepatic uptake as a mechanism for drug-drug interaction between cerivastatin and cyclosporin A
    • Shitara Y, Itoh T, Sato H, Li AP, Sugiyama Y. Inhibition of transporter-mediated hepatic uptake as a mechanism for drug-drug interaction between cerivastatin and cyclosporin A. J Pharmacol Exp Ther 2003; 304(2): 610-6.
    • (2003) J Pharmacol Exp Ther , vol.304 , Issue.2 , pp. 610-616
    • Shitara, Y.1    Itoh, T.2    Sato, H.3    Li, A.P.4    Sugiyama, Y.5
  • 13
    • 24944537019 scopus 로고    scopus 로고
    • Functional expression of sinusoidal drug transporters in primary human and rat hepatocytes
    • Jigorel E, Le Vee M, Boursier-Neyret C, Bertrand M, Fardel O. Functional expression of sinusoidal drug transporters in primary human and rat hepatocytes. Drug Metab Dispos 2005; 33(10): 1418-22.
    • (2005) Drug Metab Dispos , vol.33 , Issue.10 , pp. 1418-1422
    • Jigorel, E.1    Le Vee, M.2    Boursier-Neyret, C.3    Bertrand, M.4    Fardel, O.5
  • 14
    • 0036301269 scopus 로고    scopus 로고
    • Cytochrome P450 expression in human hepatocytes and hepatoma cell lines: Molecular mechanisms that determine lower expression in cultured cells
    • Rodriguez-Antona C, Donato MT, Boobis A, et al. Cytochrome P450 expression in human hepatocytes and hepatoma cell lines: molecular mechanisms that determine lower expression in cultured cells. Xenobiotica 2002; 32(6): 505-20.
    • (2002) Xenobiotica , vol.32 , Issue.6 , pp. 505-520
    • Rodriguez-Antona, C.1    Donato, M.T.2    Boobis, A.3
  • 15
    • 4043137923 scopus 로고    scopus 로고
    • An integrated, multidisciplinary approach for drug safety assessment
    • Li AP. An integrated, multidisciplinary approach for drug safety assessment. Drug Discov Today 2004b; 9(16): 687-93.
    • (2004) Drug Discov Today , vol.9 , Issue.16 , pp. 687-693
    • Li, A.P.1
  • 16
    • 7444258439 scopus 로고    scopus 로고
    • A comprehensive approach for drug safety assessment
    • Li AP. A comprehensive approach for drug safety assessment. Chem Biol Interact 2004c; 150(1): 27-33.
    • (2004) Chem Biol Interact , vol.150 , Issue.1 , pp. 27-33
    • Li, A.P.1
  • 17
    • 34247505574 scopus 로고    scopus 로고
    • Human hepatocytes: Isolation, cryopreservation and applications in drug development
    • (a) Li AP. Human hepatocytes: Isolation, cryopreservation and applications in drug development. Chem Biol Interact 2007; 168(1): 16-29.
    • (2007) Chem Biol Interact , vol.168 , Issue.1 , pp. 16-29
    • Li, A.P.1
  • 18
    • 7444268462 scopus 로고    scopus 로고
    • Adverse hepatic drug reactions: Inflammatory episodes as consequence and contributor
    • (b) Ganey PE, Luyendyk JP, Maddox JF, Roth RA. Adverse hepatic drug reactions: inflammatory episodes as consequence and contributor. Chem Biol Interact 2004; 150(1): 35-51.
    • (2004) Chem Biol Interact , vol.150 , Issue.1 , pp. 35-51
    • Ganey, P.E.1    Luyendyk, J.P.2    Maddox, J.F.3    Roth, R.A.4
  • 19
    • 0037058255 scopus 로고    scopus 로고
    • Correlation between troglitazone cytotoxicity and drug metabolic enzyme activities in cryopreserved human hepatocytes
    • Hewitt NJ, Lloyd S, Hayden M, et al. Correlation between troglitazone cytotoxicity and drug metabolic enzyme activities in cryopreserved human hepatocytes. Chem Biol Interact 2002; 142(1-2): 73-82.
    • (2002) Chem Biol Interact , vol.142 , Issue.1-2 , pp. 73-82
    • Hewitt, N.J.1    Lloyd, S.2    Hayden, M.3
  • 20
    • 0037058254 scopus 로고    scopus 로고
    • hepatotoxicity of toglitazone and rosiglitazone among cryopreserved human hepatocytes from 37 donors. Chem Biol Interact 202;
    • Lloyd S, Hayden MJ, Sakai Y, et al. Differential in vitro hepatotoxicity of toglitazone and rosiglitazone among cryopreserved human hepatocytes from 37 donors. Chem Biol Interact 202; 142(1-2): 57-71.
    • Differential in vitro , vol.142 , Issue.1-2 , pp. 57-71
    • Lloyd, S.1    Hayden, M.J.2    Sakai, Y.3
  • 21
    • 0037058236 scopus 로고    scopus 로고
    • Production of intracellular 35S-glutathione by rat and human hepatocytes for the quantification of xenobiotic reactive intermediates
    • Hartman NR, Cysyk RL, Bruneau-Wack C, Thenot JP, Parker RJ, Strong JM. Production of intracellular 35S-glutathione by rat and human hepatocytes for the quantification of xenobiotic reactive intermediates. Chem Biol Interact 2002; 142(1-2): 43-55.
    • (2002) Chem Biol Interact , vol.142 , Issue.1-2 , pp. 43-55
    • Hartman, N.R.1    Cysyk, R.L.2    Bruneau-Wack, C.3    Thenot, J.P.4    Parker, R.J.5    Strong, J.M.6
  • 22
    • 0037058246 scopus 로고    scopus 로고
    • Identification of glutathione conjugates of troglitazone in human hepatocytes
    • Prabhu S, Fackett A, Lloyd S, et al. Identification of glutathione conjugates of troglitazone in human hepatocytes. Chem Biol Interact 2002; 142(1-2): 83-97.
    • (2002) Chem Biol Interact , vol.142 , Issue.1-2 , pp. 83-97
    • Prabhu, S.1    Fackett, A.2    Lloyd, S.3
  • 23
    • 20244376331 scopus 로고    scopus 로고
    • In vitro bioactivation of dihydrobenoxathiin selective estrogen receptor modulators by cytochrome P450 3A4 in human liver microsomes: Formation of reactive iminium and quinone type metabolites
    • Zhang Z, Chen Q, Li Y, et al. In vitro bioactivation of dihydrobenoxathiin selective estrogen receptor modulators by cytochrome P450 3A4 in human liver microsomes: formation of reactive iminium and quinone type metabolites. Chem Res Toxicol 2005; 18(4): 675-85.
    • (2005) Chem Res Toxicol , vol.18 , Issue.4 , pp. 675-685
    • Zhang, Z.1    Chen, Q.2    Li, Y.3
  • 24
    • 33645471864 scopus 로고    scopus 로고
    • Reaction of geldanamycin and C17-substituted analogues with glutathione: Product identifications and pharmacological implications
    • Cysyk RL, Parker RJ, Barchi JJ Jr, Steeg PS, Hartman NR, Strong JM. Reaction of geldanamycin and C17-substituted analogues with glutathione: product identifications and pharmacological implications. Chem Res Toxicol 2006; 19(3): 376-81.
    • (2006) Chem Res Toxicol , vol.19 , Issue.3 , pp. 376-381
    • Cysyk, R.L.1    Parker, R.J.2    Barchi Jr, J.J.3    Steeg, P.S.4    Hartman, N.R.5    Strong, J.M.6
  • 25
    • 85033532182 scopus 로고    scopus 로고
    • Tetracycline-induced steatosis in primary canine hepatocyte cultures
    • Amacher DE, Martin BA. Tetracycline-induced steatosis in primary canine hepatocyte cultures. Fundam Appl Toxicol 1997; 40(2): 256-63.
    • (1997) Fundam Appl Toxicol , vol.40 , Issue.2 , pp. 256-263
    • Amacher, D.E.1    Martin, B.A.2
  • 26
    • 29944438253 scopus 로고    scopus 로고
    • Metabolism and transporter-mediated drug-drug interactions of the endothelin-A receptor antagonist CI-1034
    • Sahi J, Sinz MW, Campbell S, et al. Metabolism and transporter-mediated drug-drug interactions of the endothelin-A receptor antagonist CI-1034. Chem Biol Interact 2006; 159(2): 156-68.
    • (2006) Chem Biol Interact , vol.159 , Issue.2 , pp. 156-168
    • Sahi, J.1    Sinz, M.W.2    Campbell, S.3
  • 27
    • 33144479565 scopus 로고    scopus 로고
    • Establishment of an in vitro high-thoughtput screening assay for detecting phospholipidosis-inducing potential
    • Kasahara T, Tomita K, Murano H, et al. Establishment of an in vitro high-thoughtput screening assay for detecting phospholipidosis-inducing potential. Toxicol Sci 2006; 90(1): 133-41.
    • (2006) Toxicol Sci , vol.90 , Issue.1 , pp. 133-141
    • Kasahara, T.1    Tomita, K.2    Murano, H.3
  • 28
    • 33749128073 scopus 로고    scopus 로고
    • Drug-induced philspholipidosis: Issues and future directions
    • Reasor MJ, Hastings KL, Ulrich RG. Drug-induced philspholipidosis: issues and future directions. Expert Opin Drug Saf 2006, 5(4): 567-83.
    • (2006) Expert Opin Drug Saf , vol.5 , Issue.4 , pp. 567-583
    • Reasor, M.J.1    Hastings, K.L.2    Ulrich, R.G.3
  • 29
    • 0037058253 scopus 로고    scopus 로고
    • A review of the common properties of drugs with idiosyncratic hepatotoxicity and the "multiple determinant hypothesis" for the manifestation of idiosyncratic drug toxicity
    • Li AP. A review of the common properties of drugs with idiosyncratic hepatotoxicity and the "multiple determinant hypothesis" for the manifestation of idiosyncratic drug toxicity. Chem Biol Interact 2002; 142(1-2): 7-23.
    • (2002) Chem Biol Interact , vol.142 , Issue.1-2 , pp. 7-23
    • Li, A.P.1
  • 30
    • 11144355440 scopus 로고    scopus 로고
    • Applications of microarrays with toxicologically relevant genes (tox genes) for the evaluation of chemical toxicants in Sprague Dawley rats in vivo and human hepatocytes in vitro
    • Kier LD, Neft R, Tang L, et al. Applications of microarrays with toxicologically relevant genes (tox genes) for the evaluation of chemical toxicants in Sprague Dawley rats in vivo and human hepatocytes in vitro. Mutat Res 2004; 549(1-2): 101-13.
    • (2004) Mutat Res , vol.549 , Issue.1-2 , pp. 101-113
    • Kier, L.D.1    Neft, R.2    Tang, L.3
  • 31
    • 11244334169 scopus 로고    scopus 로고
    • Microarray analysis in human hepatocytes suggests a mechanism for hepatotoxicity induced by trovafloxacin
    • Liguori MJ, Anderson MG, Bukofzer S, et al. Microarray analysis in human hepatocytes suggests a mechanism for hepatotoxicity induced by trovafloxacin. Hepatology 2005; 41(1): 177-86.
    • (2005) Hepatology , vol.41 , Issue.1 , pp. 177-186
    • Liguori, M.J.1    Anderson, M.G.2    Bukofzer, S.3
  • 32
    • 7444259030 scopus 로고    scopus 로고
    • 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 frorm five major organs and MCF4 adenocarcinoma breast cancer cells
    • 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 frorm five major organs and MCF4 adenocarcinoma breast cancer cells. Chem Biol Interact 2004; 150(1): 129-36.
    • (2004) Chem Biol Interact , vol.150 , Issue.1 , pp. 129-136
    • Li, A.P.1    Bode, C.2    Sakai, Y.3
  • 33
    • 33746255370 scopus 로고    scopus 로고
    • Future of toxicology-metabolic activation and drug design: Challenges and opportunities in chemical toxicology
    • Baillie TA. Future of toxicology-metabolic activation and drug design: challenges and opportunities in chemical toxicology. Chem Res Toxico 2006; 19(7): 889-93.
    • (2006) Chem Res Toxico , vol.19 , Issue.7 , pp. 889-893
    • Baillie, T.A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.