References
- Bayliss MK, Bell JA, Jenner WN, et al. (1999). Utility of hepatocytes to model species differences in the metabolism of loxtidine and to predict pharmacokinetic parameters in rat, dog and man. Xenobiotica 29:253–68
- Chéne P. (2003). Inhibiting the p53-MDM2 interaction: an important target for cancer therapy. Nat Rev Cancer 3:102–9
- Davies B, Morris T. (1993). Physiological parameters in laboratory animals and humans. Pharm Res 10:1093–5
- Guillemette C. (2003). Pharmacogenomics of human UDPglucuronosyltransferase enzymes. Pharmacogenomics J 3:136–58
- Hallifax D, Foster JA, Houston JB. (2010). Prediction of human metabolic clearance from in vitro systems: retrospective analysis and prospective view. Pharm Res 27:2150–61
- Hollstein M, Sidransky D, Vogelstein B, Harris CC. (1991). p53 Mutations in human cancers. Science 253:49–53
- Hosea NA, Collard WT, Cole S, et al. (2009). Prediction of human pharmacokinetics from preclinical information: comparative accuracy of quantitative prediction approaches. J Clin Pharmacol 49:513–33
- Houston JB. (1994). Utility of in vitro drug metabolism data in predicting in vivo metabolic clearance. Biochem Pharmacol 47:1469–79
- Iwatsubo T, Hirota N, Ooie T, et al. (1997). Prediction of in vivo drug metabolism in the human liver from in vitro metabolism data. Pharmacol Ther 73:147–71
- Jancova P, Anzenbacher P, Anzenbacherova E. (2010). Phase II drug metabolizing enzymes. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub 154:103–16
- Kilford PJ, Stringer R, Sohal B, et al. (2009). Prediction of drug clearance by glucuronidation from in vitro data: use of combined cytochrome P450 and UDP-glucuronosyltransferase cofactors in alamethicin-activated human liver microsomes. Drug Metab Dispos 37:82–9
- Lavé T, Dupin S, Schmitt C, et al. (1997). The use of human hepatocytes to select compounds based on their expected hepatic extraction ratios in humans. Pharm Res 14:152–5
- Levine AJ, Oren M. (2009). The first 30 years of p53: growing ever more complex. Nat Rev Cancer 9:749–58
- Li AP, Lu C, Brent JA, et al. (1999). 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 121:17–35
- Momand J, Zambetti GP, Olson DC, et al. (1992). The mdm-2 oncogene product forms a complex with the p53 protein and inhibits p53-mediated transactivation. Cell 69:1237–45
- Obach RS. (1996). The importance of non-specific binding in in vitro matrices, its impact on enzyme kinetic studies of drug metabolism reactions, and implications for in vitro-in vivo correlations. Drug Metab Dispos 24:1047–9
- Obach RS. (1997). Nonspecific binding to microsomes: impact on scale-up of in vitro intrinsic clearance to hepatic clearance as assessed through examination of warfarin, imipramine, and propranolol. Drug Metab Dispos 25:1359–69
- Obach RS. (1999). Prediction of human clearance of twenty-nine drugs from hepatic microsomal intrinsic clearance data. An examination of in vitro half-live approach and nonspecific binding to microsomes. Drug Metab Dispos 27:1350–9
- Oliner JD, Kinzler KW, Meltzer PS, et al. (1992). Amplification of a gene encoding a p53-associated protein in human sarcomas. Nature 358:80–3
- Pang KS, Rowland M. (1977). Hepatic clearance of drugs. I. Theoretical considerations of a “well-stirred” model and a “parallel tube” model. Influence of hepatic blood flow, plasma and blood cell binding, and the hepatocellular enzymatic activity on hepatic drug clearance. J Pharmacokinet Biopharm 5:625–53
- Riley RJ, McGinnity DF, Austin RP. (2005). A unified model for predicting human hepatic, metabolic clearance from in vitro intrinsic clearance data in hepatocytes and microsomes. Drug Metab Dispos 33:1304–11
- Ritter JK. (2000). Roles of glucuronidation and UDP-glucuronosyltransferases in xenobiotic bioactivation reactions. Chem Biol Interact 129:171–93
- Sidelmann U, Christiansen E, Krogh L, et al. (1997). Purification and 1H NMR spectroscopic characterization of phase II metabolites of tolfenamic acid. Drug Metab Dispos 25:725–31
- Soars MG, Burchell B, Riley RJ. (2002). In vitro analysis of human drug glucuronidation and prediction of in vivo metabolic clearance. J Pharmacol Exp Ther 301:382–90
- Soars MG, McGinnity DF, Grime K, Riley RJ. (2007). The pivotal role of hepatocytes in drug discovery. Chem Biol Interact 168:2–15
- Sohlenius-Sternbeck AK. (2006). Determination of the hepatocellularity number for human, dog, rabbit, rat and mouse livers from protein concentration measurements. Toxicol In Vitro 20:1582–6
- Sun D, Li Z, Rew Y, et al. (2014). Discovery of AMG 232, a potent, selective, and orally bio-available inhibitor of the MDM2-p53 interaction. J Med Chem 57:1454–72
- Tang H, Mayersohn M. (2005). A novel model for prediction of human drug clearance by allometric scaling. Drug Metab Dispos 33:1297–303
- Vassilev LT. (2007). MDM2 inhibitors for cancer therapy. Trends Mol Med 13:23–31
- Vazquez A, Bond EE, Levine AJ, Bond GL. (2008). The genetics of the p53 pathway, apoptosis and cancer therapy. Nat Rev Drug Discov 7:979–87
- Ward KW, Smith BR. (2004). A comprehensive quantitative and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog, and monkey to humans. II. Volume of distribution and mean residence time. Drug Metab Dispos 32:612–19
- Wilkinson GR, Shand DG. (1975). A physiological approach to hepatic drug clearance. Clin Pharmacol Ther 18:377–90
- Ye Q, Jiang BM, Chan H, et al. (2008). Clearance prediction based on hepatocytes: Impact of non-specific binding. Paper presented at ISSX, Washington, DC. Available from http://issx.confex.com/issx/15na/webprogram/Paper11580.html
- Yu SX, Li S, Yang H, et al. (2005). A novel liquid chromatography/tandem mass spectrometry based depletion method for measuring red blood cell partitioning of pharmaceutical compounds in drug discovery. Rapid Commun Mass Spectrom 19:250–4