Bibliography
- VENKATAKRISHNAN K, VON MOLTKE LL, GREENBLATT DJ: Human drug metabolism and the cytochromes P450: application and relevance of in vitro models. J. Clin. Pharmacol. (2001) 41(11):1149–1179.
- 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.
- LIN JH, LU AY: Interindividual variability in inhibition and induction of cytochrome P450 enzymes. Ann. Rev. Pharmacol. Toxicol. (2001) 41:535–567.
- CERVENKOVA K, BELEJOVA M, VESELY J et al.: Cell suspensions, cell cultures, and tissue slices - important metabolic in vitro systems. Biomed. Pap. Med. Fac. Univ. Palacky. Olomouc. Czech. Repub. (2001) 145(2):57–60.
- LECLUYSE EL, ALEXANDRE E, HAMILTON GA et al. : Isolation and culture of primary human hepatocytes. Methods Mol. Biol. (2005) 290:207–229.
- MCGINNITY DF, SOARS MG, URBANOWICZ RA, RILEY RJ: Evaluation of fresh and cryopreserved hepatocytes as in vitro drug metabolism tools for the prediction of metabolic clearance. Drug Metab. Dispos. (2004) 32(11):1247–1253.
- EKINS S, RING BJ, GRACE J, MCROBIE-BELLE DJ, WRIGHTON SA: Present and future in vitro approaches for drug metabolism. J. Pharmacol. Toxicol. Methods (2000) 44(1):313–324.
- BRANDON EF, RAAP CD, MEIJERMAN I, BEIJNEN JH, SCHELLENS JH: An update on in vitro test methods in human hepatic drug biotransformation research: pros and cons. Toxicol. Appl. Pharmacol. (2003) 189(3):233–246.
- GOMEZ-LECHON MJ, DONATO MT, CASTELL JV, JOVER R: Human hepatocytes in primary culture: the choice to investigate drug metabolism in man. Curr. Drug Metab. (2004) 5(5):443–462.
- PLANT N: Strategies for using in vitro screens in drug metabolism. Drug Discov. Today (2004) 9(7): 328–336.
- CROSS DM, BAYLISS MK: A commentary on the use of hepatocytes in drug metabolism studies during drug discovery and development. Drug Metab. Rev. (2000) 32(2):219–240.
- SINZ M: In vitro metabolism: hepatocytes. In: Handbook of Drug Metabolism. TF Woolf (Ed.), Marcel Dekker, Inc., New York, USA (1999):401–424.
- GOMEZ-LECHON MJ, DONATO MT, CASTELL JV, JOVER R: Human hepatocytes as a tool for studying toxicity and drug metabolism. Curr. Drug Metab. (2003) 4(4):292–312.
- PARKINSON A, MUDRA DR, JOHNSON C, DWYER A, CARROLL KM: The effects of gender, age, ethnicity, and liver cirrhosis on cytochrome P450 enzyme activity in human liver microsomes and inducibility in cultured human hepatocytes. Toxicol. Appl. Pharmacol. (2004) 199(3):193–209.
- BJORNSSON TD, CALLAGHAN JT, EINOLF HJ et al. : The conduct of in vitro and in vivo drug—drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective. Drug Metab. Dispos. (2003) 31(7):815–832.
- LECLUYSE EL: Human hepatocyte culture systems for the in vitro evaluation of cytochrome P450 expression and regulation. Eur. J. Pharm. Sci. (2001) 13(4):343–368.
- WORBOYS PD, CARLILE DJ: Implications and consequences of enzyme induction on preclinical and clinical drug development. Xenobiotica (2001) 31(8–9):539–556.
- LI AP, GORYCKI PD, HENGSTLER JG et al.: Present status of the application of cryopreserved hepatocytes in the evaluation of xenobiotics: consensus of an international expert panel. Chem. Biol. Interact. (1999) 121(1):117–123.
- LLOYD TD, ORR S, SKETT P, BERRY DP, DENNISON AR: Cryopreservation of hepatocytes: a review of current methods for banking. Cell Tissue Bank. (2003) 4(1):3–15.
- REDER-HILZ B, ULLRICH M, RINGEL M et al.: Metabolism of propafenone and verapamil by cryopreserved human, rat, mouse and dog hepatocytes: comparison with metabolism in vivo. Naunyn Schmiedebergs Arch. Pharmacol. (2004) 369(4):408–417.
- REINACH B, DE SOUSA G, DOSTERT P et al.: Comparative effects of rifabutin and rifampicin on cytochromes P450 and UDP-glucuronosyl-transferases expression in fresh and cryopreserved human hepatocytes. Chem. Biol. Interact. (1999) 121(1):37–48.
- SILVA JM, DAY SH, NICOLL-GRIFFITH DA: Induction of cytochrome-P450 in cryopreserved rat and human hepatocytes. Chem. Biol. Interact. (1999) 121(1):49–63.
- SKETT P, ROBERTS P, KHAN S: Maintenance of steroid metabolism and hormone responsiveness in cryopreserved dog, monkey and human hepatocytes. Chem. Biol. Interact. (1999) 121(1):65–76.
- HENGSTLER JG, UTESCH D, STEINBERG P et al.: Cryopreserved primary hepatocytes as a constantly available in vitro model for the evaluation of human and animal drug metabolism and enzyme induction. Drug Metab. Rev. (2000) 32(1):81–118.
- ROYMANS D, VAN LOOVEREN C, LEONE A et al.: Determination of cytochrome P450 1A2 and cytochrome P450 3A4 induction in cryopreserved human hepatocytes. Biochem. Pharmacol. (2004) 67(3):427–437.
- ROYMANS D, ANNAERT P, VAN HOUDT J: Expression and Induction potential of cytochrome P450 in human cryopreserved hepatocytes. Drug Metab. Dispos. (2005) (in press).
- LAZARO CA, CROAGER EJ, MITCHELL C et al.: Establishment, characterization, and long-term maintenance of cultures of human fetal hepatocytes. Hepatology (2003) 38(5):1095–1106.
- WRIGHTON SA, VANDENBRANDEN M: Isolation and characterization of human fetal liver cytochrome P450HLp2: a third member of the P450III gene family. Arch. Biochem. Biophys. (1989) 268(1):144–151.
- HAKKOLA J, RAUNIO H, PURKUNEN R et al.: Cytochrome P450 3A expression in the human fetal liver: evidence that CYP3A5 is expressed in only a limited number of fetal livers. Biol. Neonate (2001) 80(3):193–201.
- CHIBA M, XU X, NISHIME JA, BALANI SK, LIN JH: Hepatic microsomal metabolism of montelukast, a potent leukotriene D4 receptor antagonist, in humans. Drug Metab. Dispos. (1997) 25(9):1022–1031.
- WILLIAMS JA, RING BJ, CANTRELL VE et al. : Comparative metabolic capabilities of CYP3A4, CYP3A5, and CYP3A7. Drug Metab. Dispos. (2002) 30(8):883–891.
- RAUCY JL, CARPENTER SJ: The expression of xenobiotic-metabolizing cytochromes P450 in fetal tissues. J. Pharmacol. Toxicol. Methods (1993) 29(3):121–128.
- RING JA, GHABRIAL H, CHING MS, SMALLWOOD RA, MORGAN DJ: Fetal hepatic drug elimination. Pharmacol. Ther. (1999) 84(3):429–445.
- HINES RN, MCCARVER DG: The ontogeny of human drug-metabolizing enzymes: Phase I oxidative enzymes. J. Pharmacol. Exp. Ther. (2002) 300(2):355–360.
- MCCARVER DG, HINES RN: The ontogeny of human drug-metabolizing enzymes: Phase II conjugation enzymes and regulatory mechanisms. J. Pharmacol. Exp. Ther. (2002) 300(2):361–366.
- MATSUNAGA T, MARUYAMA M, HARADA E et al.: Expression and induction of CYP3As in human fetal hepatocytes. Biochem. Biophys. Res. Commun. (2004) 318(2):428–434.
- PENG DR, PACIFICI GM, RANE A: Human fetal liver cultures: basal activities and inducibility of epoxide hydrolases and aryl hydrocarbon hydroxylase. Biochem. Pharmacol (1984) 33(1):71–77.
- MCELHATTON P: General principles of drug use in pregnancy. The Pharmaceutical Journal (2003) 270(7236):232–234.
- INOUE C, YAMAMOTO H, NAKAMURA T, ICHIHARA A, OKAMOTO H: Nicotinamide prolongs survival of primary cultured hepatocytes without involving loss of hepatocyte-specific functions. J. Biol. Chem. (1989) 264(9):4747–4750.
- KOST DP, MICHALOPOULOS GK: Effect of 2% dimethyl sulfoxide on the mitogenic properties of epidermal growth factor and hepatocyte growth factor in primary hepatocyte culture. J. Cell. Physiol. (1991) 147(2):274–280.
- KATSURA N, IKAI I, MITAKA T et al.: Long-term culture of primary human hepatocytes with preservation of proliferative capacity and differentiated functions. J. Surg. Res. (2002) 106(1):115–123.
- CHAN C, BERTHIAUME F, WASHIZU J, TONER M, YARMUSH ML: Metabolic preconditioning of cultured cells in physiological levels of insulin: generating resistance to the lipid-accumulating effects of plasma in hepatocytes. Biotechnol. Bioeng. (2002) 78(7):753–760.
- RUNGE D, RUNGE DM, JAGER D et al.: Serum-free, long-term cultures of human hepatocytes: maintenance of cell morphology, transcription factors, and liverspecific functions. Biochem. Biophys. Res. Commun. (2000) 269(1):46–53.
- LEE DH, YOON HH, LEE JH et al.: Enhanced liver-specific functions of endothelial cell-covered hepatocyte heterospheroids. Biochem. Eng. J. (2004) 20(2–3):181–187.
- WATANABE T, SHIBATA N, WESTERMAN KA et al.: Establishment of immortalized human hepatic stellate scavenger cells to develop bioartificial livers. Transplantation (2003) 75(11):1873–1880.
- KUDRYAVTSEVA EI, ENGELHARDT NV: Requirement of 3D extracellular network for maintenance of mature hepatocyte morphology and suppression of α-fetoprotein synthesis in vitro. Immunology Letters (2003) 90(1):25–31.
- ZEILINGER K, SAUER IM, PLESS G et al.: Three-dimensional co-culture of primary human liver cells in bioreactors for in vitro drug studies: effects of the initial cell quality on the long-term maintenance of hepatocyte-specific functions. ATLA (2002) 30(5):525–538.
- HARIMOTO M, YAMATO M, HIROSE M et al.: Novel approach for achieving double-layered cell sheets coculture: overlaying endothelial cell sheets onto monolayer hepatocytes utilizing temperature-responsive culture dishes. J. Biomed. Mater. Res. (2002) 62(3):464–470.
- DONATO MT, CASTELL JV, GOMEZ-LECHON MJ: Co-cultures of hepatocytes with epithelial-like cell lines: expression of drug-biotransformation activities by hepatocytes. Cell Biol. Toxicol. (1991) 7(1):1–14.
- DUNN JC, YARMUSH ML, KOEBE HG, TOMPKINS RG: Hepatocyte function and extracellular matrix geometry: long-term culture in a sandwich configuration.[erratum appears in FASEB J 1989 May;3(7):1873]. FASEB J. (1989) 3(2):174–177.
- GOMEZ-LECHON MJ, JOVER R, DONATO T et al. : Long-term expression of differentiated functions in hepatocytes cultured in three-dimensional collagen matrix. J. Cell. Physiol. (1998) 177(4):553–562.
- LECLUYSE EL, BULLOCK PL, PARKINSON A: Strategies for restoration and maintenance of normal hepatic structure and function in long-term cultures of rat hepatocytes. Adv. Drug Del. Rev. (1996) 22(1–2):133–186.
- LECLUYSE E, MADAN A, HAMILTON G et al. : Expression and regulation of cytochrome P450 enzymes in primary cultures of human hepatocytes. J. Biochem. Mol. Toxicol. (2000) 14(4):177–188.
- KERN A, BADER A, PICHLMAYR R, SEWING KF: Drug metabolism in hepatocyte sandwich cultures of rats and humans. Biochem. Pharmacol. (1997) 54(7):761–772.
- KONO Y, YANG S, ROBERTS EA: Extended primary culture of human hepatocytes in a collagen gel sandwich system. In Vitro Cell Dev. Biol. Anim. (1997) 33(6):467–472.
- COECKE S, ROGIERS V, BAYLISS M et al.: The use of long-term hepatocyte cultures for detecting induction of drug metabolising enzymes: the current status - ECVAM hepatocytes and metabolically competent systems task force report 1. ATLA (1999) 27(4):579–638.
- DE SMET K, CAVIN C, VERCRUYSSE A, ROGIERS V: Collagen Type I gel cultures of adult rat hepatocytes as a screening induction model for cytochrome P450-dependent enzymes. ATLA (2001) 29(2):179–192.
- TIPPIN TK, HAMILTON G, MOORE L et al.: CYP3A induction by N-hydroxyformamide tumor necrosis factor-α converting enzyme/matrix metalloproteinase inhibitors use of a pregname X receptor activation assay and primary hepatocyte culture for assessing induction potential in humans. Drug Metab. Dispos. (2003) 31(7):870–877.
- TREIJTEL N, BARENDREGT A, FREIDIG AP, BLAAUBOER BJ, VAN EIJKEREN JC: Modeling the in vitro intrinsic clearance of the slowly metabolized compound tolbutamide determined in sandwich-cultured rat hepatocytes. Drug Metab. Dispos. (2004) 32(8):884–891.
- ENGL T, BOOST KA, LECKEL K et al.: Phosphorylation of hepatocyte growth factor receptor and epidermal growth factor receptor of human hepatocytes can be maintained in a (3D) collagen sandwich culture system. Toxicol. In Vitro (2004) 18(4):527–532.
- DEGLMANN CJ, EBNER T, LUDWIG E et al.: Protein binding capacity in vitro changes metabolism of substrates and influences the predictability of metabolic pathways in vivo. Toxicol. In Vitro (2004) 18(6):835–840.
- NUSSLER AK, WANG A, NEUHAUS P et al.: The suitability of hepatocyte culture models to study various aspects of drug metabolism. Altex (2001) 18(2):91–101.
- RINGEL M, VON MACH MA, SANTOS R et al.: Hepatocytes cultured in alginate microspheres: an optimized technique to study enzyme induction. Toxicology (2005) 206(1):153–167.
- TONG JZ, SARRAZIN S, CASSIO D, GAUTHIER F, ALVAREZ F: Application of spheroid culture to human hepatocytes and maintenance of their differentiation. Biology of the Cell (1994) 81(1):77–81.
- GEBHARDT R, HENGSTLER JG, MULLER D et al.: New hepatocyte in vitro systems for drug metabolism: metabolic capacity and recommendations for application in basic research and drug development, standard operation procedures. Drug Metab. Rev. (2003) 35(2–3):145–213.
- GREUET J, PICHARD L, OURLIN JC et al. : Effect of cell density and epidermal growth factor on the inducible expression of CYP3A and CYP1A genes in human hepatocytes in primary culture. Hepatology (1997) 25(5):1166–1175.
- HAMILTON GA, JOLLEY SL, GILBERT D et al.: Regulation of cell morphology and cytochrome P450 expression in human hepatocytes by extracellular matrix and cell-cell interactions. Cell Tissue Res. (2001) 306(1):85–99.
- DE KANTER R, MONSHOUWER M, MEIJER DK, GROOTHUIS GM: Precision-cut organ slices as a tool to study toxicity and metabolism of xenobiotics with special reference to non-hepatic tissues. Curr. Drug Metab. (2002) 3(1):39–59.
- LERCHE-LANGRAND C, TOUTAIN HJ: Precision-cut liver slices: characteristics and use for in vitro pharmaco-toxicology. Toxicology (2000) 153(1–3):221–253.
- CARLILE DJ, HAKOOZ N, HOUSTON JB: Kinetics of drug metabolism in rat liver slices: IV. Comparison of ethoxycoumarin clearance by liver slices, isolated hepatocytes, and hepatic microsomes from rats pretreated with known modifiers of cytochrome P450 activity. Drug Metab. Dispos. (1999) 27(4):526–532.
- ANDERSSON TB, SJOBERG H, HOFFMANN KJ et al.: An assessment of human liver-derived in vitro systems to predict the in vivo metabolism and clearance of almokalant. Drug Metab. Dispos. (2001) 29(5):712–720.
- VANDENBRANDEN M, WRIGHTON SA, EKINS S et al.: Alterations of the catalytic activities of drugmetabolizing enzymes in cultures of human liver slices. Drug Metab. Dispos. (1998) 26(11):1063–1068.
- RENWICK AB, WATTS PS, EDWARDS RJ et al. : Differential maintenance of cytochrome P450 enzymes in cultured precision-cut human liver slices. Drug Metab. Dispos. (2000) 28(10):1202–1209.
- EDWARDS RJ, PRICE RJ, WATTS PS et al. : Induction of cytochrome P450 enzymes in cultured precision-cut human liver slices. Drug Metab. Dispos. (2003) 31(3):282–288.
- MARTIN H, SARSAT JP, DE WI et al. : Induction of cytochrome P450 2B6 and 3A4 expression by phenobarbital and cyclophosphamide in cultured human liver slices. Pharm. Res. (2003) 20(4):557–568.
- DE KANTER R, OLINGA P, HOF I et al.: A rapid and simple method for cryopreservation of human liver slices. Xenobiotica (1998) 28(3):225–234.
- DAY SH, NICOLL-GRIFFITH DA, SILVA JM: Cryopreservation of rat and human liver slices by rapid freezing. Cryobiology (1999) 38(2):154–159.
- GRANHALL C, FLOBY E, NORDMARK A et al.: Characterization of testosterone metabolism and 7-hydroxycoumarin conjugation by rat and human liver slices after storage in liquid nitrogen for 1 h up to 6 months. Xenobiotica (2002) 32(11):985–996.
- CASCIO SM: Novel strategies for immortalization of human hepatocytes. Artif. Organs (2001) 25(7):529–538.
- SELDEN C, HODGSON H: Cellular therapies for liver replacement. Transpl. Immunol. (2004) 12(3–4):273–288.
- WERNER A, DUVAR S, MUTHING J et al.: Cultivation of immortalized human hepatocytes HepZ on macroporous CultiSpher G microcarriers. Biotechnol. Bioeng. (2000) 68(1):59–70.
- GAO J, ANN GL, STORM SM et al. : Identification of in vitro protein biomarkers of idiosyncratic liver toxicity. Toxicol. In Vitro (2004) 18(4):533–541.
- HORROCKS C, HALSE R, SUZUKI R, SHEPHERD PR: Human cell systems for drug discovery. Curr. Opin. Drug Discov. Devel. (2003) 6(4):570–575.
- SMALLEY M, LEIPER K, TOOTLE R et al.: Immortalization of human hepatocytes by temperature-sensitive SV40 large-T antigen. In Vitro Cell Dev. Biol. Anim. (2001) 37(3):166–168.
- KUNIEDA T, KOBAYASHI N, SAKAGUCHI M et al.: Transduction of immortalized human hepatocytes with p21 to enhance differentiated phenotypes. Cell Transplant. (2002) 11(5):421–428.
- OBINATA M: Possible applications of conditionally immortalized tissue cell lines with differentiation functions. Biochem. Biophys. Res. Commun. (2001) 286(4):667–672.
- KOBAYASHI N, FUJIWARA T, WESTERMAN KA et al.: Prevention of acute liver failure in rats with reversibly immortalized human hepatocytes. Science (2000) 287(5456):1258–1262.
- KOBAYASHI N, WESTERMAN KA, TANAKA N, FOX IJ, LEBOULCH P: A reversibly immortalized human hepatocyte cell line as a source of hepatocyte-based biological support. Addict. Biol. (2001) 6(4):293–300.
- OKITSU T, KOBAYASHI N, JUN HS et al.: Transplantation of reversibly immortalized insulin-secreting human hepatocytes controls diabetes in pancreatectomized pigs. Diabetes (2004) 53(1):105–112.
- INOUE Y, MIYAZAKI M, TSUJI T et al.: Reactivation of liver-specific gene expression in an immortalized human hepatocyte cell line by introduction of the human HNF4alpha2 gene. Int. J. Mol. Med. (2001) 8(5):481–487.
- AKIYAMA I, TOMIYAMA K, SAKAGUCHI M et al.: Expression of CYP3A4 by an immortalized human hepatocyte line in a three-dimensional culture using a radial-flow bioreactor. Int. J. Mol. Med. (2004) 14(4):663–668.
- SVANBERG A, DWYER JO, GOLDFARB P, SINDEN J: Development of novel human hepatocyte cell lines. 10th International Congress of Toxicology. Tampere, Finland (2004).
- STEEN D: Immortalized human hepatocytes: a new advance in convenience and performance. Current Separations (2004) 20(4):137–140.
- MILLS JB, ROSE KA, SADAGOPAN N, SAHI J, DE MORAIS SM: Induction of drug metabolism enzymes and MDR1 using a novel human hepatocyte cell line. J. Pharmacol. Exp. Ther. (2004) 309(1):303–309.
- MASIMIREMBWA CM, OTTER C, BERG M et al.: Heterologous expression and kinetic characterization of human cytochromes P450: validation of a pharmaceutical tool for drug metabolism research. Drug Metab. Dispos. (1999) 27(10):1117–1122.
- GILLAM EM: Human cytochrome P450 enzymes expressed in bacteria - reagents to probe molecular interactions in toxicology. Clin. Exp. Pharmacol. Physiol. (1998) 25(11):877–886.
- PARIKH A, GILLAM EM, GUENGERICH FP: Drug metabolism by Escherichia coli expressing human cytochromes P450. Nat. Biotechnology (1997) 15(8):784–788.
- PAINE MJ, GILHAM D, ROBERTS GC, WOLF CR: Functional high level expression of cytochrome P450 CYP2D6 using baculoviral expression systems. Arch. Biochem. Biophys. (1996) 328(1):143–150.
- FRIEDBERG T, WOLF CR: Recombinant DNA technology as an investigative tool in drug metabolism research. Adv. Drug Del. Rev. (1996) 22(1–2):187–213.
- RAUSCHENBACH R, GIESCHEN H, HUSEMANN M, SALOMON B, HILDEBRAND M: Stable expression of human cytochrome P450 3A4 in V79 cells and its application for metabolic profiling of ergot derivatives. Eur. J. Pharmacol. (1995) 293(3):183–190.
- YOKOI T, SAWADA M, KAMATAKI T: Polymorphic drug metabolism: studies with recombinant Chinese hamster cells and analyses in human populations. Pharmacogenetics (1995) 5:S65–S69.
- GASSER R, FUNK C, MATZINGER P, KLEMISCH W, VIGER-CHOUGNET A: Use of transgenic cell lines in mechanistic studies of drug metabolism. Toxicol. In Vitro (1999) 13(4–5):625–632.
- MCGINNITY DF, RILEY RJ: Predicting drug pharmacokinetics in humans from in vitro metabolism studies. Biochem. Soc. Trans. (2001) 29(Pt2):135–139.
- COURT MH, DUAN SX, GUILLEMETTE C et al.: Stereoselective conjugation of oxazepam by human UDPglucuronosyltransferases (UGTs): S-oxazepam is glucuronidated by UGT2B15, while R-oxazepam is glucuronidated by UGT2B7 and UGT1A9. Drug Metab. Dispos. (2002) 30(11):1257–1265.
- ANDREWS J, ABD-ELLAH MF, RANDOLPH NL et al.: Comparative study of the metabolism of drug substrates by human cytochrome P450 3A4 expressed in bacterial, yeast and human lymphoblastoid cells. Xenobiotica (2002) 32(11):937–947.
- MCGINNITY DF, GRIFFIN SJ, MOODY GC et al.: Rapid characterization of the major drug-metabolizing human hepatic cytochrome P450 enzymes expressed in Escherichia coli. Drug Metab. Dispos. (1999) 27(9):1017–1023.
- NAKAJIMA M, TANE K, NAKAMURA S et al.: Evaluation of approach to predict the contribution of multiple cytochrome P450s in drug metabolism using relative activity factor: effects of the differences in expression levels of NADPH-cytochrome P450 reductase and cytochrome b(5) in the expression system and the differences in the marker activities. J. Pharm. Sci. (2002) 91(4):952–963.
- IWATSUBO T, HIROTA N, OOIE T et al.: Prediction of in vivo drug metabolism in the human liver from in vitro metabolism data. Pharmacol. Ther. (1997) 73(2):147–171.
- RODRIGUEZ AD: Applications of heterologous expressed and purified human drug-metabolizing enzymes: an industrial perspective. In: Handbook of Drug Metabolism. TF Woolf (Ed.), Marcel Dekker, Inc., New York, USA (1999):279–319.
- FRIEDBERG T, HENDERSON CJ, PRITCHARD MP, WOLF CR: In vivo and in vitro recombinant DNA technology as a powerful tool in drug development. In: Handbook of Drug Metabolism. TF Woolf (Ed.), Marcel Dekker, Inc., New York, USA (1999):321–361.
- BRIMER C, DALTON JT, ZHU Z et al.: Creation of polarized cells coexpressing CYP3A4, NADPH cytochrome P450 reductase and MDR1/P-glycoprotein. Pharm. Res. (2000) 17(7):803–810.
- BARON JM, GOH LB, YAO D, WOLF CR, FRIEDBERG T: Modulation of P450 CYP3A4-dependent metabolism by P-glycoprotein: implications for P450 phenotyping. J. Pharmacol. Exp. Ther. (2001) 296(2):351–358.
- CRESPI CL, PENMAN BW, HU M: Development of Caco-2 cells expressing high levels of cDNA-derived cytochrome P4503A4. Pharm. Res. (1996) 13(11):1635–1641.
- SCHMIEDLIN-REN P, THUMMEL KE, FISHER JM et al.: Expression of enzymatically active CYP3A4 by Caco-2 cells grown on extracellular matrix-coated permeable supports in the presence of 1α,25-dihydroxyvitamin D3. Molecular Pharmacology (1997) 51(5):741–754.
- CRESPI CL, FOX L, STOCKER P, HU M, STEIMEL DT: Analysis of drug transport and metabolism in cell monolayer systems that have been modified by cytochrome P4503A4 cDNA-expression. Eur. J. Pharm. Sci. (2000) 12(1):63–68.
- DAI Y, CEDERBAUM AI: Inactivation and degradation of human cytochrome P4502E1 by CCl4 in a transfected HepG2 cell line. J. Pharmacol. Exp. Ther. (1995) 275(3):1614–1622.
- DOEHMER J: V79 Chinese hamster cells genetically engineered for cytochrome P450 and their use in mutagenicity and metabolism studies. Toxicology (1993) 82(1–3):105–118.
- OGG MS, WILLIAMS JM, TARBIT M et al.: A reporter gene assay to assess the molecular mechanisms of xenobioticdependent induction of the human CYP3A4 gene in vitro. Xenobiotica (1999) 29(3):269–279.
- PLANT NJ, OGG M, CROWDER M, GIBSON GG: Control and statistical analysis of in vitro reporter gene assays. Anal. Biochem. (2000) 278(2):170–174.
- RAUCY J, WARFE L, YUEH MF, ALLEN SW: A cell-based reporter gene assay for determining induction of CYP3A4 in a high-volume system. J. Pharmacol. Exp. Ther. (2002) 303(1):412–423.
- ETA J, YENGI L, XIANG Q, KAO J, SCATINA J: Establishment of a CYP3A4 reporter gene assay: validation using known CYP3A4 inducers, Wyeth compound tanaproget and comparator 3-ketodesogestrel. Drug Metab. Rev. (2005) 36(S1):188.
- EL SANKARY W, GIBSON GG, AYRTON A, PLANT N: Use of a reporter gene assay to predict and rank the potency and efficacy of CYP3A4 inducers. Drug Metab. Dispos. (2001) 29(11):1499–1504.
- LUO G, CUNNINGHAM M, KIM S et al.: CYP3A4 induction by drugs: correlation between a pregnane X receptor reporter gene assay and CYP3A4 expression in human hepatocytes. Drug Metab. Dispos. (2002) 30(7):795–804.
- YUEH MF, KAWAHARA M, RAUCY J: High volume bioassays to assess CYP3A4- mediated drug interactions: induction and inhibition in a single cell line. Drug Metab. Dispos. (2005) 33(1):38–48.
- YOUNG M, HUANG JJZ: Evaluation of a stably transfected human PXR cell line to determine potential 3A4 induction in human. Drug Metab. Rev. (2005) 36(S1):308.
- LEMAIRE G, DE SOUSA G, RAHMANI R: A PXR reporter gene assay in a stable cell culture system: CYP3A4 and CYP2B6 induction by pesticides. Biochem. Pharmacol (2004) 68(12):2347–2358.
- SPINK BC, PANG S, PENTECOST BT, SPINK DC: Induction of cytochrome P450 1B1 in MDA-MB-231 human breast cancer cells by non-ortho-substituted polychlorinated biphenyls. Toxicol. In Vitro (2002) 16(6):695–704.
- ALLEN SW, MUELLER L, WILLIAMS SN, QUATTROCHI LC, RAUCY J: The use of a high-volume screening procedure to assess the effects of dietary flavonoids on human CYP1A1 expression. Drug Metab. Dispos. (2001) 29(8):1074–1079.
- GALIJATOVIC A, OTAKE Y, WALLE UK, WALLE T: Extensive metabolism of the flavonoid chrysin by human Caco-2 and Hep G2 cells. Xenobiotica (1999) 29(12):1241–1256.
- ALEXANDRE E, DAVID P, VIOLLON C et al.: Expression of cytochromes P450 2E1, 3A4 and 1A1/1A2 in growing and confluent human HepG2 hepatoma cells - effect of ethanol. Toxicol. In Vitro (1999) 13(3):427–435.
- WALLE T, OTAKE Y, GALIJATOVIC A, RITTER JK, WALLE UK: Induction of UDP-glucuronosyltransferase UGT1A1 by the flavonoid chrysin in the human hepatoma cell line hep G2. Drug Metab. Dispos. (2000) 28(9):1077–1082.
- WILKENING S, STAHL F, BADER A: Comparison of primary human hepatocytes and hepatoma cell line HepG2 with regard to their biotransformation properties. Drug Metab. Dispos. (2003) 31(8):1035–1042.
- HEWITT NJ, HEWITT P: Phase I and II enzyme characterization of two sources of HepG2 cell lines. Xenobiotica (2004) 34(3):243–256.
- ELIZONDO G, MEDINA-DIAZ IM: Induction of CYP3A4 by 1alpha,25- dyhydroxyvitamin D3 in HepG2 cells. Life Sci. (2003) 73(2):141–149.
- IWANARI M, NAKAJIMA M, KIZU R, HAYAKAWA K, YOKOI T: Induction of CYP1A1, CYP1A2, and CYP1B1 mRNAs by nitropolycyclic aromatic hydrocarbons in various human tissue-derived cells: chemical-, cytochrome P450 isoform-, and cell-specific differences. Arch. Toxicol. (2002) 76(5–6):287–298.
- KRUSEKOPF S, ROOTS I, HILDEBRANDT AG, KLEEBERG U: Time-dependent transcriptional induction of CYP1A1, CYP1A2 and CYP1B1 mRNAs by H+/K+-ATPase inhibitors and other xenobiotics. Xenobiotica (2003) 33(2):107–118.
- BAPIRO TE, ANDERSSON TB, OTTER C, HASLER JA, MASIMIREMBWA CM: Cytochrome P450 1A1/2 induction by antiparasitic drugs: dose-dependent increase in ethoxyresorufin O-deethylase activity and mRNA caused by quinine, primaquine and albendazole in HepG2 cells. Eur. J. Clin. Pharmacol. (2002) 58(8):537–542.
- BALIHAROVA V, SKALOVA L, MAAS RF et al. : The effects of mebendazole on P4501A activity in rat hepatocytes and HepG2 cells. Comparison with tiabendazole and omeprazole. J. Pharm. Pharmacol. (2003) 55(6):773–781.
- USUI T, SAITOH Y, KOMADA F: Induction of CYP3As in HepG2 cells by several drugs. Association between induction of CYP3A4 and expression of glucocorticoid receptor. Biol. Pharm. Bull (2003) 26(4):510–517.
- GOMEZ-LECHON MJ, DONATO T, JOVER R et al.: Expression and induction of a large set of drug-metabolizing enzymes by the highly differentiated human hepatoma cell line BC2. Eur. J. Biochem. (2001) 268(5):1448–1459.
- JONES EA, TOSH D, FORRESTER LM: Liver. In: Handbook of Stem Cells (Volume 1). Embryonic Stem Cells. R Lanza, J Gearhart, B Hogan, D Melton, R Pedersen, J Thomson, M West (Eds), Elsevier Academic Press, New York, USA (2004):359–370.
- GROMPE M: Adult Liver Stem Cells. In: Handbook of Stem Cells (Volume 2). Adult and Fetal Stem Cells. R Lanza, H Blau, D Melton, M Moore, TE Donall, C Verfaillie, I Weissmann, M West (Eds), Elsevier Academic Press, New York, USA (2004):483–495.
- SHAY JW, WRIGHT WE: Hayflick, his limit, and cellular ageing. Nat. Rev. Mol. Cell Biol. (2000) 1(1):72–76.
- SCHULDINER M, YANUKA O, ITSKOVITZ-ELDOR J, MELTON DA, BENVENISTY N: Effects of eight growth factors on the differentiation of cells derived from human embryonic stem cells. Proc. Natl. Acad. Sci. USA (2000) 97(21):11307–11312.
- RAMBHATLA L, CHIU CP, KUNDU P, PENG Y, CARPENTER MK: Generation of hepatocyte-like cells from human embryonic stem cells. Cell Transplant. (2003) 12(1):1–11.
- VESSEY CJ, DE LA HALL PM: Hepatic stem cells: a review. Pathology (2001) 33(2):130–141.
- THEISE ND, NIMMAKAYALU M, GARDNER R et al.: Liver from bone marrow in humans. Hepatology (2000) 32(1):11–16.
- PETERSEN BE, BOWEN WC, PATRENE KD et al.: Bone marrow as a potential source of hepatic oval cells. Science (1999) 284(5417):1168–1170.
- ALISON MR, POULSOM R, JEFFERY R et al.: Hepatocytes from non-hepatic adult stem cells. Nature (2000) 406(6793):257.
- LAGASSE E, CONNORS H, AL DHALIMY M et al.: Purified hematopoietic stem cells can differentiate into hepatocytes in vivo. Nat. Med (2000) 6(11):1229–1234.
- LEE KD, KUO TK, WHANG-PENG J et al.: In vitro hepatic differentiation of human mesenchymal stem cells. Hepatology (2004) 40(6):1275–1284.
- SCHWARTZ RE, REYES M, KOODIE L et al.: Multipotent adult progenitor cells from bone marrow differentiate into functional hepatocyte-like cells. J. Clin. Invest. (2002) 109(10):1291–1302.
- ZHAO Y, GLESNE D, HUBERMAN E: A human peripheral blood monocytederived subset acts as pluripotent stem cells. Proc. Natl. Acad. Sci. USA (2003) 100(5):2426–2431.
- BARHAM HM, LENNARD MS, TUCKER GT: An evaluation of cytochrome P450 isoform activities in the female dark agouti (DA) rat: relevance to its use as a model of the CYP2D6 poor metaboliser phenotype. Biochem. Pharmacol (1994) 47(8):1295–1307.
- WU D, CEDERBAUM AI: Ethanol and arachidonic acid produce toxicity in hepatocytes from pyrazole-treated rats with high levels of CYP2E1. Mol. Cell Biochem. (2000) 204(1–2):157–167.
- XIE W, BARWICK JL, DOWNES M et al.: Humanized xenobiotic response in mice expressing nuclear receptor SXR. Nature (2000) 406(6794):435–439.
- CORCHERO J, GRANVIL CP, AKIYAMA TE et al.: The CYP2D6 humanized mouse: effect of the human CYP2D6 transgene and HNF4alpha on the disposition of debrisoquine in the mouse. Mol. Pharmacol. (2001) 60(6):1260–1267.
- CHEUNG C, YU AM, WARD JM et al.: The CYP2E1 humanized transgenic mouse: role in acetaminophen hepatotoxicity. Drug Metab. Dispos. (2005) 33(3):449–457.
- GRANVIL CP, YU AM, ELIZONDO G et al.: Expression of the human CYP3A4 gene in the small intestine of transgenic mice: in vitro metabolism and pharmacokinetics of midazolam. Drug Metab. Dispos. (2003) 31(5):548–558.
- LI Y, YOKOI T, KITAMURA R et al.: Establishment of transgenic mice carrying human fetus-specific CYP3A7. Arch. Biochem. Biophys. (1996) 329(2):235–240.
- TATENO C, YOSHIZANE Y, SAITO N et al.: Near completely humanized liver in mice shows human-type metabolic responses to drugs. Am. J. Pathol. (2004) 165(3):901–912.
- KATOH M, MATSUI T, NAKAJIMA M et al.: Expression of human cytochromes P450 in chimeric mice with humanized liver. Drug Metab. Dispos. (2004) 32(12):1402–1410.
Websites
- http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4079B1_04_Topic2-TabA.pdf FDA website. Preliminary FDA concept paper on Drug Interaction Studies (2004).