The correction factors do help in improving the prediction of human clearance from animal data

Journal of Pharmaceutical Sciences

Volumn 94, Issue 5, 2005, Pages 940-945

  Mahmood, Iftekhar ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ACTISOMIDE; CEFAZOLIN; COUMARIN; FUROSEMIDE; GAVESTINEL; INOGATRAN; LAMIFIBAN; PELRINONE; PENEM DERIVATIVE; SINITRODIL; TEBUFELONE; TRIMETHADIONE; TROVAFLOXACIN;

ANALYTICAL ERROR; DRUG CLEARANCE; DRUG EXCRETION; DRUG METABOLISM; HUMAN; LIVER BLOOD FLOW; MONKEY; NONHUMAN; NOTE; RAT;

EID: 20344382965     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.20299     Document Type: Note

References (46)

1. Nagilla R, Ward KW. 2004. A comprehensive analysis of the role of correction factors in the allometric predictivity of clearance from rat, dog, and monkey to humans. J Pharm Sci 93:2522-2534.
2. Wajima T, Fukumura K, Yano Y, Oguma T. 2002. Prediction of human clearance from animal data and molecular structural parameters using multivariate regression analysis. J Pharm Sci 91:2489-2499.
3. Mahmood I, Balian JD. 1996. Interspecies scaling: predicting clearance of drugs in humans: Three different approaches. Xenobiotica 26:887-895.
4. Boxenbaum H, Fertig JB. 1984. Scaling of antipyrine intrinsic clearance of unbound drug on 15 mammalian species. Eur J Drug Metab Pharmacokinet 9:177-183.
5. Obach RS, Baxter JG, Liston TE, Silber BM, Jones C, Macintyre F, Rance OJ, Wastall P. 1997. The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism. J Pharmacol Exp Ther 283:46-58.
6. Lave TH, Dupin S, Schmitt C, Chou RC, Jaeck D, Coassolo PH. 1997. Integration of in vitro data into allometric scaling to predict hepatic metabolic clearance in man: Application to 10 extensively metabolized drugs. J Pharm Sci 86: 584-590.
7. Karalis V, Macheras P. 2002. Drug disposition viewed in terms of the fractal volume of distribution. Pharm Res 19:696-703.
8. Davies B, Morris T. 1993. Physiological parameters in laboratory animals and humans. Pharm Res 10: 1093-1096.
9. Mahmood I, Sahajwalla C. 2002. Interspecies scaling of biliary excreted drugs. J Pharm Sci 91:1908-1914.
10. Duhart HM, Fogle CM, Gillam MP, Bailey JR, Slikker W Jr, Paule MG. 1993. Pharmacokinetics of cocaine in pregnant and nonpregnant rhesus monkeys. Reprod Toxicol 7:429-437.
11. Clement JG, Lee MJ, Simons KJ, Briggs CJ. 1990. Pharmacokinetics of the acetylcholinesterase oxime reactivator, HI-6, in rhesus monkeys (Macaca mulatta): Effect of atropine, diazepam, and methoxyflurane anesthesia. Biopharm Drug Dispos 11:227-232.
12. de Miranda P, Krasny HC, Page DA, Elion GB. 1982. Species differences in the disposition of acyclovir. Am J Med 73:31-35.
13. Johnson JA, Benziger DP. 1985. Metabolism and disposition of amifloxacin in laboratory animals. Antimicrob Agents Chemother 27:774-781.
14. El Dareer SM, Struck RF, White VM, Mellett LB, Hill DL. 1977. Distribution and metabolism of prednisone in mice, dogs, and monkeys. Cancer Treat Rep 61:1279-1289.
15. El Dareer SM, White VM, Chen FP, Mellet LB, Hill DL. 1977. Distribution and metabolism of vincristine in mice, rats, dogs, and monkeys. Cancer Treat Rep 61:1269-1277.
16. Yeung JH, Breckenridge AM, Park BK. 1983. Drug-protein conjugates-IV. The effect of acute renal failure on the disposition of [14C]captopril in the rat. Biochem Pharmacol 32:2467-2472.
17. Tse FL, Smith HT, Ballard FH, Nicoletti J. 1990. Disposition of fluvastatin, an inhibitor of HMG-COA reductase, in mouse, rat, dog, and monkey. Biopharm Drug Dispos 11:519-531.
18. Chang T. 1987. Preclinical and clinical pharmacokinetics of pirmenol. Am J Cardiol 59:15H-19H.
19. Sanwald-Ducray P, Dow J. 1997. Prediction of the pharmacokinetic parameters of reduced dolasetron in man using in vitro-in vivo and interspecies allometric scaling. Xenobiotica 27:189-201.
20. Dockens RC, Santone KS, Mitroka JG, Morrison RA, Jemal M, Greene DS, Barbhaiya RH. 2000. Disposition of radiolabeled ifetroban in rats, dogs, monkeys, and humans. Drug Metab Dispos 28: 973-980.
21. Maruhn D, Siefert HM, Weber H, Ramsch K, Suwelack D. 1985. Pharmacokinetics of nimodipine. I. Communication: absorption, concentration in plasma and excretion after single administration of [14C]nimodipine in rat, dog and monkey. Arzneimittelforschung 35:1781-1786.
22. Salmon J, Coussediere D, Cousty C, Raynaud JP. 1983. Pharmacokinetics and metabolism of moxestrol in animals: Rat, dog and monkey. J Steroid Biochem 19:1223-1234.
23. Salmon J, Coussediere D, Cousty C, Raynaud JP. 1983. Pharmacokinetics and metabolism of moxestrol in humans. J Steroid Biochem 18:565-573.
24. Turner DM. 1975. Influence of route of administration on metabolism of [14C]nicotine in four species. Xenobiotica 5:553-561.
25. Runkel R, Chaplin M, Boost G, Segre E, Forchielli E. 1972. Absorption, distribution, metabolism, and excretion of naproxen in various laboratory animals and human subjects. J Pharm Sci 61:703-708.
26. Boyes RN, Adams HJ, Duce BR. 1970. Oral absorption and disposition kinetics of lidocaine hydrochloride in dogs. J Pharmacol Exp Ther 174:1-8.
27. Sawada Y, Hanano M, Sugiyama Y, Iga T. 1984. Prediction of the disposition of β-lactam antibiotics in humans from pharmacokinetic parameters in animals. J Pharmacokin Biopharm 12:241-261.
28. Eriksson UG, Renberg L, Bredberg U, Teger-Nilsson AC, Regardh CG. 1998. Animal pharmacokinetics of inogatran, a low-molecular-weight thrombin inhibitor with potential use as an antithrombotic drug. Biopharm Drug Dispos 19:55-64.
29. Cruze CA, Kelm GR, Meredith MP. 1995. Interspecies scaling of tebufelone pharmacokinetic data and application to preclinical toxicology. Pharm Res 12:895-901.
30. Lave T, Saner A, Coassolo P, Brandt R, Schmitt-Hoffmann AH, Chou RC. 1996. Animal pharmacokinetics and interspecies scaling from animals to man of lamifiban, a new platelet aggregation inhibitor. J Pharm Pharmacol 48:573-577.
31. Ritschel WA, Vachharajani NN, Johnson RD, Hussain AS. 1991. Interspecies scaling of the pharmacokinetic parameters of coumarin among six different mammalian species. Methods Find Exp Clin Pharmacol 13:697-702.
32. Giachetti C, Bertolino M, Canali S, Lombardini E, Monzani MV, Sala A, Zanolo G. 1998. Pharmacokinetic study in dogs and monkeys after single intravenous and oral administrations of [14C]-ITF-296. Eur J Drug Metab Pharmacokin 23:239-250.
33. Monzani MV, Coltro G, Jiritano L, Sala A. 1995. Pharmacokinetic profile of ITF 296 in rats and dogs. J Cardiovasc Pharmacol 269(Suppl 4):S67-S71.
34. Sardina M, Love R, Mizrahi J, Monzani V, Bianchini C. 1995. Safety and pharmacologic activity of a new nitrate ester, ITF 296, after intravenous administration in healthy volunteers. J Cardiovasc Pharmacol 269(Suppl 4):S72-S79.
35. Monzani MV, Coltro G, Sala A, Sardina M. 1999. Pharmacokinetics of ITF 296 (Sinitrodil) a novel organic nitrate, in healthy volunteers. Eur J Pharm Sci 7:179-184.
36. Cook CS, Rozek LF, Stolzenbach J, Anderson S, Schoenhard GL, Karim A. 1993. Pharmacokinetics of a novel antiarrhythmic drug, actisomide. Pharm Res 10:427-433.
37. Tanaka E, Ishikawa A, Horie T. 1999. In vivo and in vitro trimethadione oxidation activity of the liver from various animal species including mouse, hamster, rat, rabbit, dog, monkey and human. Hum Exp Toxicol 18:12-16.
38. Efthymiopoulos C, Battaglia R, Strolin Benedetti M. 1991. Animal pharmacokinetics and interspecies scaling of FCE 22101, a penem antibiotic. J Antimicrob Chemother 4:517-526.
39. Jannuzzo MG, Mandelli M, Benedetti MS, Moro E, Carnovali M, Vaiani R, Sassella D. 1989. Pharmacokinetics and tolerance of a new penem antibiotic, FCE 22101, in healthy volunteers after a single intravenous dose. Eur J Clin Pharmacol 36:633-635.
40. Doyle E, Chasseaud LF, Miller JN. 1982. Comparative pharmacokinetics of frusemide in female rhesus monkeys, cynomolgus monkeys and baboons. Comp Biochem Physiol C 71C:89-93.
41. Hirai J, Miyazaki H, Taneike T. 1992. The pharmacokinetics and pharmacodynamics of furosemide in the anaesthetized dog. J Vet Pharmacol Ther 15:231-239.
42. Prandota J, Pruitt AW. 1991. Pharmacokinetic, biliary excretion, and metabolic studies of 14C-furosemide in the rat. Xenobiotica 21:725-736.
43. Teng R, Girard D, Gootz TD, Foulds G, Liston TE. 1996. Pharmacokinetics of trovafloxacin (CP-99,219), a new quinolone, in rats, dogs, and monkeys. Antimicrob Agents Chemother 40:561-566.
44. Vincent J, Venitz J, Teng R, Baris BA, Willavize SA, Polzer RJ, Friedman HL. 1997. Pharmacokinetics and safety of trovafloxacin in healthy male volunteers following administration of single intravenous doses of the prodrug, alatrofloxacin. J Antimicrob Chemother 39(Suppl B):75-80.
45. Ivarone L, Hoke JF, Bottacini M, Barnaby R, Preston GC. 1999. First time in human for GV196771: Interspecies scaling applied on dose selection. J Clin Pharmacol 39:560-566.
46. Ward KW, Smith BR. 2004. A comprehensive quantitative and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog, and monkey to humans. I. Clearance. Drug Metab Dispos 32:603-611.