Prediction of clinical CYP3A4 induction using cryopreserved human hepatocytes

References

• Aninat C, Piton A, Glaise D, Le Charpentier T, Langouët S, Morel F, Guguen-Guillouzo C, Guillouzo A. (2006). Expression of cytochromes P450, conjugating enzymes and nuclear receptors in human hepatoma HepaRG cells. Drug Metab Dispos 34:75–83.
   PubMed Web of Science ®Google Scholar
• El-Sankary W, Gibson GG, Ayrton A, Plant N. (2001). Use of a reporter gene assay to predict and rank the potency and efficacy of CYP3A4 inducers. Drug Metab Dispos 29:1499–1504.
   PubMed Web of Science ®Google Scholar
• Fahmi OA, Boldt S, Kish M, Obach RS, Tremaine LM. (2008). Prediction of drug-drug interactions from in vitro induction data: application of the relative induction score approach using cryopreserved human hepatocytes. Drug Metab Dispos 36:1971–1974.
   PubMed Web of Science ®Google Scholar
• Garcia M, Rager J, Wang Q, Strab R, Hidalgo IJ, Owen A, Li J. (2003). Cryopreserved human hepatocytes as alternative in vitro model for cytochrome p450 induction studies. In Vitro Cell Dev Biol Anim 39:283–287.
   PubMed Web of Science ®Google Scholar
• Hewitt NJ, Lechón MJ, Houston JB, Hallifax D, Brown HS, Maurel P, Kenna JG, Gustavsson L, Lohmann C, Skonberg C, Guillouzo A, Tuschl G, Li AP, LeCluyse E, Groothuis GM, Hengstler JG. (2007a). Primary hepatocytes: current understanding of the regulation of metabolic enzymes and transporter proteins, and pharmaceutical practice for the use of hepatocytes in metabolism, enzyme induction, transporter, clearance, and hepatotoxicity studies. Drug Metab Rev 39:159–234.
   PubMed Web of Science ®Google Scholar
• Hewitt NJ, Lecluyse EL, Ferguson SS. (2007b). Induction of hepatic cytochrome P450 enzymes: methods, mechanisms, recommendations, and in vitro-in vivo correlations. Xenobiotica 37:1196–1224.
   PubMed Web of Science ®Google Scholar
• Ito K, Iwatsubo T, Kanamitsu S, Ueda K, Suzuki H, Sugiyama Y. (1998). Prediction of pharmacokinetic alterations caused by drug-drug interactions: metabolic interaction in the liver. Pharmacol Rev 50:387–412.
   PubMed Web of Science ®Google Scholar
• Kafert-Kasting S, Alexandrova K, Barthold M, Laube B, Friedrich G, Arseniev L, Hengstler JG. (2006). Enzyme induction in cryopreserved human hepatocyte cultures. Toxicology 220:117–125.
   PubMed Web of Science ®Google Scholar
• Kanebratt KP, Andersson TB. (2008). HepaRG cells as an in vitro model for evaluation of cytochrome P450 induction in humans. Drug Metab Dispos 36:137–145.
   PubMed Web of Science ®Google Scholar
• Kaneko A, Kato M, Sekiguchi N, Mitsui T, Takeda K, Aso Y. (2009). In vitro model for the prediction of clinical CYP3A4 induction using HepaRG cells. Xenobiotica 39:803–810.
   PubMed Web of Science ®Google Scholar
• Kato M, Chiba K, Horikawa M, Sugiyama Y. (2005). The quantitative prediction of in vivo enzyme-induction caused by drug exposure from in vitro information on human hepatocytes. Drug Metab Pharmacokinet 20:236–243.
   PubMedGoogle Scholar
• Kostrubsky VE, Ramachandran V, Venkataramanan R, Dorko K, Esplen JE, Zhang S, Sinclair JF, Wrighton SA, Strom SC. (1999). The use of human hepatocyte cultures to study the induction of cytochrome P-450. Drug Metab Dispos 27:887–894.
   PubMed Web of Science ®Google Scholar
• Luo G, Cunningham M, Kim S, Burn T, Lin J, Sinz M, Hamilton G, Rizzo C, Jolley S, Gilbert D, Downey A, Mudra D, Graham R, Carroll K, Xie J, Madan A, Parkinson A, Christ D, Selling B, LeCluyse E, Gan LS. (2002). CYP3A4 induction by drugs: correlation between a pregnane X receptor reporter gene assay and CYP3A4 expression in human hepatocytes. Drug Metab Dispos 30:795–804.
   PubMed Web of Science ®Google Scholar
• Madan A, Graham RA, Carroll KM, Mudra DR, Burton LA, Krueger LA, Downey AD, Czerwinski M, Forster J, Ribadeneira MD, Gan LS, LeCluyse EL, Zech K, Robertson P Jr, Koch P, Antonian L, Wagner G, Yu L, Parkinson A. (2003). Effects of prototypical microsomal enzyme inducers on cytochrome P450 expression in cultured human hepatocytes. Drug Metab Dispos 31:421–431.
   PubMed Web of Science ®Google Scholar
• McGinnity DF, Zhang G, Kenny JR, Hamilton GA, Otmani S, Stams KR, Haney S, Brassil P, Stresser DM, Riley RJ. (2009). Evaluation of multiple in vitro systems for assessment of CYP3A4 induction in drug discovery: human hepatocytes, pregnane X receptor reporter gene, and Fa2N-4 and HepaRG cells. Drug Metab Dispos 37:1259–1268.
   PubMed Web of Science ®Google Scholar
• Meneses-Lorente G, Pattison C, Guyomard C, Chesné C, Heavens R, Watt AP, Sohal B. (2007). Utility of long-term cultured human hepatocytes as an in vitro model for cytochrome p450 induction. Drug Metab Dispos 35:215–220.
   PubMed Web of Science ®Google Scholar
• Moore LB, Parks DJ, Jones SA, Bledsoe RK, Consler TG, Stimmel JB, Goodwin B, Liddle C, Blanchard SG, Willson TM, Collins JL, Kliewer SA. (2000). Orphan nuclear receptors constitutive androstane receptor and pregnane X receptor share xenobiotic and steroid ligands. J Biol Chem 275:15122–15127.
   PubMed Web of Science ®Google Scholar
• Nishimura M, Koeda A, Suganuma Y, Suzuki E, Shimizu T, Nakayama M, Satoh T, Narimatsu S, Naito S. (2007). Comparison of inducibility of CYP1A and CYP3A mRNAs by prototypical inducers in primary cultures of human, cynomolgus monkey, and rat hepatocytes. Drug Metab Pharmacokinet 22:178–186.
   PubMed Web of Science ®Google Scholar
• Obach RS, Walsky RL, Venkatakrishnan K, Gaman EA, Houston JB, Tremaine LM. (2006). The utility of in vitro cytochrome P450 inhibition data in the prediction of drug-drug interactions. J Pharmacol Exp Ther 316:336–348.
   PubMed Web of Science ®Google Scholar
• Ogino M, Nagata K, Yamazoe Y. (2002). Selective suppressions of human CYP3A forms, CYP3A5 and CYP3A7, by troglitazone in HepG2 cells. Drug Metab Pharmacokinet 17:42–46.
   PubMedGoogle Scholar
• Parkinson A, Mudra DR, Johnson C, Dwyer A, Carroll KM. (2004). 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 199:193–209.
   PubMed Web of Science ®Google Scholar
• Ripp SL, Mills JB, Fahmi OA, Trevena KA, Liras JL, Maurer TS, de Morais SM. (2006). Use of immortalized human hepatocytes to predict the magnitude of clinical drug-drug interactions caused by CYP3A4 induction. Drug Metab Dispos 34:1742–1748.
   PubMed Web of Science ®Google Scholar
• Rost KL, Brösicke H, Heinemeyer G, Roots I. (1994). Specific and dose-dependent enzyme induction by omeprazole in human beings. Hepatology 20:1204–1212.
   PubMed Web of Science ®Google Scholar
• Roymans D, Van Looveren C, Leone A, Parker JB, McMillian M, Johnson MD, Koganti A, Gilissen R, Silber P, Mannens G, Meuldermans W. (2004). Determination of cytochrome P450 1A2 and cytochrome P450 3A4 induction in cryopreserved human hepatocytes. Biochem Pharmacol 67:427–437.
   PubMed Web of Science ®Google Scholar
• Shou M, Hayashi M, Pan Y, Xu Y, Morrissey K, Xu L, Skiles GL. (2008). Modeling, prediction, and in vitro in vivo correlation of CYP3A4 induction. Drug Metab Dispos 36:2355–2370.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration (USFDA). (2006). FDA guidance for industry: Drug interaction studies-study design, data analysis, and implications for dosing and labeling. Washington, DC.
   Google Scholar
• Usui T, Saitoh Y, Komada F. (2003). Induction of CYP3As in HepG2 cells by several drugs. Association between induction of CYP3A4 and expression of glucocorticoid receptor. Biol Pharm Bull 26:510–517.
   PubMed Web of Science ®Google Scholar
• von Moltke LL, Greenblatt DJ, Schmider J, Wright CE, Harmatz JS, Shader RI. (1998). In vitro approaches to predicting drug interactions in vivo. Biochem Pharmacol 55:113–122.
   PubMed Web of Science ®Google Scholar