A comparison of pharmacokinetics between humans and monkeys

Drug Metabolism and Disposition

Volumn 38, Issue 2, 2010, Pages 308-316

  Akabane, Takafumi ^a   Tabata, Kenji ^a   Kadono, Keitaro ^a   Sakuda, Shuichi ^a   Terashita, Shigeyuki ^a   Teramura, Toshio ^a  

^a ASTELLAS PHARMA INC   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOSINE TRIPHOSPHATASE; AMITRIPTYLINE; CYTOCHROME P450; CYTOCHROME P450 3A4; DEXAMETHASONE; DIGOXIN; GLYCOPROTEIN P; HYDROCHLOROTHIAZIDE; IBUPROFEN; LITHIUM CARBONATE; MIDAZOLAM MALEATE; NIFEDIPINE; PROPRANOLOL; QUINIDINE; TACROLIMUS; TIMOLOL; VERAPAMIL;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BINDING AFFINITY; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG LIVER LEVEL; DRUG METABOLISM; DRUG PENETRATION; ENZYME ACTIVITY; FIRST PASS EFFECT; HUMAN; HUMAN CELL; HUMAN VERSUS ANIMAL COMPARISON; IN VITRO SELECTION; IN VITRO STUDY; IN VIVO STUDY; INTESTINE ABSORPTION; LIVER MICROSOME; MALE; MEMBRANE PERMEABILITY; MICROSOME; MONKEY; NONHUMAN; PHARMACOKINETICS; PREDICTION; PRIORITY JOURNAL; SPECIES DIFFERENCE;

ADMINISTRATION, ORAL; ANIMALS; BIOLOGICAL AVAILABILITY; DRUG EVALUATION, PRECLINICAL; HUMANS; INJECTIONS, INTRAVENOUS; INTESTINES; LIVER; MACACA FASCICULARIS; MALE; MEMBRANES, ARTIFICIAL; MICROSOMES; MODELS, BIOLOGICAL; P-GLYCOPROTEIN; PERMEABILITY; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; PROTEIN BINDING; SPECIES SPECIFICITY; TIME FACTORS;

MACACA FASCICULARIS;

EID: 76149110084     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.109.028829     Document Type: Article

References (41)

1. Arancibia A, Corvalan F, Mella F, and Concha L (1986) Absorption and disposition kinetics of lithium carbonate following administration of conventional and controlled release formulations. Int J Clin Pharmacol Ther Toxicol 24:240-245.
2. Avdeef A, Artursson P, Neuhoff S, Lazorova L, Gråsjö J, and Tavelin S (2005) Caco-2 permeability of weakly basic drugs predicted with the double-sink PAMPA pKa(flux) method. Eur J Pharm Sci 24:333-349.
3. Borgström L, Johansson CG, Larsson H, and Lenander R (1981) Pharmacokinetics of propranolol. J Pharmacokinet Biopharm 9:419-429.
4. Chiba M, Hensleigh M, and Lin JH (1997) Hepatic and intestinal metabolism of indinavir, an HIV protease inhibitor, in rat and human microsomes. Major role of CYP3A. Biochem Pharm 53:1187-1195.
5. Chiou WL and Buehler PW (2002) Comparison of oral absorption and bioavailability of drugs between monkey and human. Pharm Res 19:868-874.
6. Davies B and Morris T (1993) Physiological parameters in laboratory animals and humans. Pharm Res 10:1093-1095.
7. De Buck SS, Sinha VK, Fenu LA, Nijsen MJ, Mackie CE, and Gilissen RA (2007) Prediction of human pharmacokinetics using physiologically based modeling: a retrospective analysis of 26 clinically tested drugs. Drug Metab Dispos 35:1766-1787.
8. Duggan DE, Yeh KC, Matalia N, Ditzler CA, and McMahon FG (1975) Bioavailability of oral dexamethasone. Clin Pharmacol Ther 18:205-209.
9. Evans GH, Nies AS, and Shand DG (1973) The disposition of propranolol. 3. Decreased half-life and volume of distribution as a result of plasma binding in man, monkey, dog and rat. J Pharmacol Exp Ther 186:114-122.
10. Fagerholm U (2007) Prediction of human pharmacokinetics - gut-wall metabolism. J Pharm Pharmacol 59:1335-1343.
11. Fisher MB and Labissiere G (2007) The role of the intestine in drug metabolism and pharmacokinetics: an industry perspective. Curr Drug Metab 8:694-699.
12. Greenblatt DJ, Pfeifer HJ, Ochs HR, Franke K, MacLaughlin DS, Smith TW, and Koch-Weser J (1977) Pharmacokinetics of quinidine in humans after intravenous, intramuscular and oral administration. J Pharmacol Exp Ther 202:365-378.
13. Hinderling PH and Hartmann D (1991) Pharmacokinetics of digoxin and main metabolites/derivatives in healthy humans. Ther Drug Monit 13:381-401.
14. Holtbecker N, Fromm MF, Kroemer HK, Ohnhaus EE, and Heidemann H (1996) The nifedipinerifampin interaction. Evidence for induction of gut wall metabolism. Drug Metab Dispos 24:1121-1123.
15. Iwatsubo T, Hirota N, Ooie T, Suzuki H, and Sugiyama Y (1996) Prediction of in vivo drug disposition from in vitro data based on physiological pharmacokinetics. Biopharm Drug Dispos 17:273-310.
16. Kadono K, Akabane T, Tabata K, Mitani Y, Hirabayashi H, Miura H, and Teramura T (2007) An empirical ADME screening system for drug discovery in astellas (2): A simplified prediction method of human intestinal availability suitable for the early stage of drug discovery. Drug Metab Rev 39 (Suppl 1):121-122.
17. Kivistö KT, Niemi M, and Fromm MF (2004) Functional interaction of intestinal CYP3A4 and P-glycoprotein. Fundam Clin Pharmacol 18:621-626.
18. Martin W, Koselowske G, Töberich H, Kerkmann T, Mangold B, and Augustin J (1990) Pharmacokinetics and absolute bioavailability of ibuprofen after oral administration of ibuprofen lysine in man. Biopharm Drug Dispos 11:265-278.
19. McAllister RG Jr and Kirsten EB (1982) The pharmacology of verapamil. IV. Kinetic and dynamic effects after single intravenous and oral doses. Clin Pharmacol Ther 31:418-426.
20. Moller A, Iwasaki K, Kawamura A, Teramura Y, Shiraga T, Hata T, Schafer A, and Undre NA (1999) The disposition of 14C-labeled tacrolimus after intravenous and oral administration in healthy human subjects. Drug Metab Dispos 27:633-636.
21. Naritomi Y, Terashita S, Kimura S, Suzuki A, Kagayama A, and Sugiyama Y (2001) Prediction of human hepatic clearance from in vivo animal experiments and in vitro metabolic studies with liver microsomes from animals and humans. Drug Metab Dispos 29:1316-1324.
22. Nishimura T, Amano N, Kubo Y, Ono M, Kato Y, Fujita H, Kimura Y, and Tsuji A (2007) Asymmetric intestinal first-pass metabolism causes minimal oral bioavailability of midazolam in cynomolgus monkey. Drug Metab Dispos 35:1275-1284.
23. Obach RS (1999) Prediction of human clearance of twenty-nine drugs from hepatic microsomal intrinsic clearance data: an examination of in vitro half-life approach and nonspecific binding to microsomes. Drug Metab Dispos 27:1350-1359.
24. Patel RB, Patel UR, Rogge MC, Shah VP, Prasad VK, Selen A, and Welling PG (1984) Bioavailability of hydrochlorothiazide from tablets and suspensions. J Pharm Sci 3:359-361.
25. Pybus J and Bowers GN Jr (1970) Measurement of serum lithium by atomic absorption spectroscopy. Clin Chem 16:139-143.
26. Sakuda S, Akabane T, and Teramura T (2006) Marked species differences in the bioavailability of midazolam in cynomolgus monkeys and humans. Xenobiotica 36:331-340.
27. Schulz P, Turner-Tamiyasu K, Smith G, Giacomini KM, and Blaschke TF (1983) Amitriptyline disposition in young and elderly normal men. Clin Pharmacol Ther 33:360-366.
28. Shen DD, Kunze KL, and Thummel KE (1997) Enzyme-catalyzed processes of first-pass hepatic and intestinal drug extraction. Adv Drug Delivery Rev 27:99-127.
29. Shibata Y, Takahashi H, Chiba M, and Ishii Y (2002) Prediction of hepatic clearance and availability by cryopreserved human hepatocytes: an application of serum incubation method. Drug Metab Dispos 30:892-896.
30. Tabata K, Hamakawa N, Sanoh S, Terashita S, and Teramura T (2009) Exploratory population pharmacokinetics (e-PPK) analysis for predicting human PK using exploratory ADME data during early drug discovery research. Eur J Drug Metab Pharmacokinet 34:117-128.
31. Takahashi M, Washio T, Suzuki N, Igeta K, Fujii Y, Hayashi M, Shirasaka Y, and Yamashita S (2008) Characterization of gastrointestinal drug absorption in cynomolgus monkeys. Mol Pharm 5:340-348.
32. Tamura K, Kobayashi M, Hashimoto K, Kojima K, Nagase K, Iwasaki K, Kaizu T, Tanaka H, and Niwa M. (1987) A highly sensitive method to assay FK-506 levels in plasma. Transplant Proc 19 (Suppl 6):23-29.
33. Thummel KE, O'Shea D, Paine MF, Shen DD, Kunze KL, Perkins JD, and Wilkinson GR (1996) Oral first-pass elimination of midazolam involves both gastrointestinal and hepatic CYP3Amediated metabolism. Clin Pharmacol Ther 59:491-502.
34. Uno Y, Hosaka S, Matsuno K, Nakamura C, Kito G, Kamataki T, and Nagata R (2007) Characterization of cynomolgus monkey cytochrome P450 (CYP) cDNAs: is CYP2C76 the only monkey-specific CYP gene responsible for species differences in drug metabolism? Arch Biochem Biophys 466:98-105.
35. Walle T, Fagan TC, Conradi EC, Walle UK, and Gaffney TE (1979) Presystemic and systemic glucuronidation of propranolol Clin Pharmacol Ther 26:167-172.
36. Wallemacq PE, Firdaous I, and Hassoun A (1993) Improvement and assessment of enzymelinked immunosorbent assay to detect low FK506 concentrations in plasma or whole blood within 6 hours. Clin Chem 39:1045-1049.
37. Wilson TW, Firor WB, Johnson GE, Holmes GI, Tsianco MC, Huber PB, and Davies RO (1982) Timolol and propranolol: bioavailability, plasma concentrations, and beta blockade. Clin Pharmcol and Ther 32:676-685.
38. Wishart DS (2007) Improving early drug discovery through ADME modeling: an overview. Drug R D 8:349-362.
39. Yang J, Jamei M, Yeo KR, Tucker GT, and Rostami-Hodjegan A (2007) Prediction of intestinal first-pass drug metabolism. Curr Drug Metab 8:676-684.
40. Yang XX, Hu ZP, Duan W, Zhu YZ, and Zhou SF (2006) Drug-herb interactions: eliminating toxicity with hard drug design. Curr Pharm Des 12:4649-4664.
41. Yu DK (1999) The contribution of P-glycoprotein to pharmacokinetic drug-drug interactions. J Clin Pharmacol 39:1203-1211.