Preclinical pharmacokinetics of MI-219, a novel human double minute 2 (HDM2) inhibitor and prediction of human pharmacokinetics

Journal of Pharmacy and Pharmaceutical Sciences

Volumn 15, Issue 2, 2012, Pages 265-280

  Zou, Peng ^a   Zheng, Nan ^a   Yu, Yanke ^a   Yu, Shanghai ^a   Sun, Wei ^a   McEachern, Donna ^a   Yang, Yongsheng ^b   Yu, Lawrence X ^b   Wang, Shaomeng ^a   Sun, Duxin ^a  

^a UNIVERSITY OF MICHIGAN   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MI 219; PROTEIN INHIBITOR; PROTEIN MDM2; UNCLASSIFIED DRUG;

ACCURACY; ALLOMETRY; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DOG; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG PROTEIN BINDING; HUMAN; HUMAN TISSUE; IN VITRO STUDY; IN VIVO STUDY; LIVER MICROSOME; MALE; MATHEMATICAL ANALYSIS; MEAN RESIDENCE TIME; MONEY; MOUSE; NONHUMAN; NONLINEAR SYSTEM; PARTITION COEFFICIENT; PREDICTION; RAT; SINGLE DRUG DOSE; SPECIES DIFFERENCE; STEADY STATE;

EID: 84860205262     PISSN: None     EISSN: 14821826     Source Type: Journal    
DOI: 10.18433/j34s4n     Document Type: Article

References (28)

1. Becquemont L, Le Bot MA, Riche C, Funck- Brentano C, Jaillon P, Beaune P. Use of heterologously expressed human cytochrome P450 1A2 to predict tacrine-fluvoxamine drug interaction in man. Pharmacogenetics 1998 Apr; 8(2):101-8.
2. Bachmann K, Pardoe D, White D. Scaling basic toxicokinetic parameters from rat to man. Environ Health Perspect 1996 Apr; 104(4):400-7.
3. McIlwrath AJ, Brunton VG, Brown R. Cell-cycle arrests and p53 accumulation induced by geldanamycin in human ovarian tumour cells. Cancer Chemotherapy and Pharmacology 1996 Mar; 37(5):423-8.
4. Mahmood I. Application of allometric principles for the prediction of pharmacokinetics in human and veterinary drug development. Adv Drug Deliv Rev 2007 Sep 30; 59(11):1177-92.
5. Hosea NA, Collard WT, Cole S, Maurer TS, Fang RX, Jones H, et al. Prediction of human pharmacokinetics from preclinical information: comparative accuracy of quantitative prediction approaches. J Clin Pharmacol 2009 May; 49(5):513-33.
6. Fagerholm U. Prediction of human pharmacokinetics--evaluation of methods for prediction of volume of distribution. J Pharm Pharmacol 2007 Sep; 59(9):1181-90.
7. Oie S, Tozer TN. Effect of altered plasma protein binding on apparent volume of distribution. J Pharm Sci 1979 Sep; 68(9):1203-5.
8. Shin BS, Kim DH, Cho CY, Park SK, Chung SG, Cho EH, et al. Pharmacokinetic scaling of SJ-8029, a novel anticancer agent possessing microtubule and topoisomerase inhibiting activities, by species invariant time methods. Biopharm Drug Dispos 2003 Jul; 24(5):191-7.
9. Wajima T, Yano Y, Fukumura K, Oguma T. Prediction of human pharmacokinetic profile in animal scale up based on normalizing time course profiles. J Pharm Sci 2004 Jul;93(7):1890-900.
10. Cho CY, Shin BS, Jung JH, Kim DH, Lee KC, Han SY, et al. Pharmacokinetic scaling of bisphenol A by species-invariant time methods. Xenobiotica 2002 Oct; 32(10):925-34.
11. Mahmood I, Yuan R. A comparative study of allometric scaling with plasma concentrations predicted by species-invariant time methods. Biopharm Drug Dispos 1999 Apr;20(3):137-44.
12. Shim HJ, Kim YC, Lee JH, Kwon JW, Kim WB, Kim YG, et al. Interspecies pharmacokinetic scaling of DA-8159, a new erectogenic, in mice, rats, rabbits and dogs, and prediction of human pharmacokinetics. Biopharm Drug Dispos 2005 Oct;26(7):269-77.
13. Goetz MP, Toft D, Reid J, Ames M, Stensgard B, Safgren S, et al. Phase I trial of 17-allylamino-17-demethoxygeldanamycin in patients with advanced cancer. J Clin Oncol 2005 Feb 20;23(6):1078-87.
14. Lee HK, Moon JK, Chang CH, Choi H, Park HW, Park BS, et al. Stereoselective metabolism of endosulfan by human liver microsomes and human cytochrome P450 isoforms. Drug Metabolism and Disposition 2006 Jul;34(7):1090-5.
15. Satoh K. The high non-enzymatic conjugation rates of some glutathione S-transferase (GST) substrates at high glutathione concentrations. Carcinogenesis 1995 Apr;16(4):869-74.
16. Boxenbaum H. Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metab Rev 1984;15(5-6):1071-121.
17. Goteti K, Brassil PJ, Good SS, Garner CE. Estimation of human drug clearance using multiexponential techniques. J Clin Pharmacol 2008 Oct;48(10):1226-36.
18. Tang H, Hussain A, Leal M, Mayersohn M, Fluhler E. Interspecies prediction of human drug clearance based on scaling data from one or two animal species. Drug Metab Dispos 2007 Oct;35(10):1886-93.
19. Chiba M, Ishii Y, Sugiyama Y. Prediction of hepatic clearance in human from in vitro data for successful drug development. AAPS J 2009 Jun;11(2):262-76.
20. Sawada Y, Hanano M, Sugiyama Y, Iga T. Prediction of the disposition of nine weakly acidic and six weakly basic drugs in humans from pharmacokinetic parameters in rats. J Pharmacokinet Biopharm 1985 Oct;13(5):477-92.
21. Obach RS, Baxter JG, Liston TE, Silber BM, Jones BC, MacIntyre F, et al. The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther 1997 Oct;283(1):46-58.
22. Shibayama T, Matsushita Y, Kurihara A, Hirota T, Ikeda T. Prediction of pharmacokinetics of CS-023 (RO4908463), a novel parenteral carbapenem antibiotic, in humans using animal data. Xenobiotica 2007 Jan;37(1):91-102.
23. Zheng N, Yu J, Zou P, Feng R, Interspecies Pharmacokinetic Scaling of Mycophenolic Acid Using Nonlinear Mixed Effects. American Association Pharmaceutical Scientists Annual Meeting; 2010; New Orleans, LA.
24. Lave T, Coassolo P, Reigner B. Prediction of hepatic metabolic clearance based on interspecies allometric scaling techniques and in vitro-in vivo correlations. Clin Pharmacokinet 1999 Mar;36(3):211-31.
25. Tang H, Mayersohn M. Utility of the coefficient of determination (r2) in assessing the accuracy of interspecies allometric predictions: illumination or illusion? Drug Metab Dispos 2007 Dec;35(12):2139-42.
26. Tang H, Mayersohn M. A novel model for prediction of human drug clearance by allometric scaling. Drug Metab Dispos 2005 Sep;33(9):1297-303.
27. Zou P, Yu Y, Zheng N, Yang Y, Paholak HJ, Yu LX, Sun D. Applications of human pharmacokinetic prediction in First-in-Human Does estimation. The AAPS Journal 2012 in press, DOI: 10.1208/s12248-012-9332-y
28. Zou P, Yu Y, Zheng N, Yang Y, Yu LX, Sun D. Prediction of Volume of Distribution at Steady-State in Humans: Comparison of Different Approaches. Expert Opin Drug Metab Toxicol. 2012 in press DOI: 10.1517/17425255.2012.682569.