Prediction of the pharmacokinetic parameters of reduced-dolasetron in man using in vitro-in vivo and interspecies allometric scaling

Xenobiotica

Volumn 27, Issue 2, 1997, Pages 189-201

  Sanwald Ducray, P ^a   Dow, J ^a,b  

^a SANOFI   (France)

^b GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DOLASETRON MESILATE;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BODY WEIGHT; BRAIN WEIGHT; CALCULATION; CONTROLLED STUDY; DOG; DRUG METABOLISM; HUMAN; HUMAN TISSUE; IN VITRO STUDY; INTRAVENOUS DRUG ADMINISTRATION; ISOTOPE LABELING; LIVER CLEARANCE; LIVER MICROSOME; LIVER WEIGHT; MALE; NONHUMAN; NORMAL HUMAN; PHARMACOKINETICS; PLASMA CLEARANCE; PLASMA HALF LIFE; PREDICTION; RABBIT; RAT; TECHNIQUE; URINARY EXCRETION;

ANIMALS; DOGS; HUMANS; INDOLES; MACACA FASCICULARIS; MALE; MICROSOMES, LIVER; QUINOLIZINES; RABBITS; RATS; RATS, SPRAGUE-DAWLEY; SEROTONIN ANTAGONISTS; SPECIES SPECIFICITY;

ANIMALIA; CANIS FAMILIARIS; ORYCTOLAGUS CUNICULUS;

EID: 0031025182     PISSN: 00498254     EISSN: None     Source Type: Journal    
DOI: 10.1080/004982597240686     Document Type: Article

References (40)

1. ASHFORTH, E. I. L., CARLILE, D. J., CHENERY, R. and HOUSTON, J. B., 1995, Prediction of in vivo disposition from in vitro system: clearance of phenytoin and tolbutamide using rat hepatic microsomal and hepatocyte data. Journal of Pharmacology and Experimental Therapeutics, 274, 761-766.
2. AUDHUY, B., CAPPELAERE, P., MARTIN, M., CERVANTES, A., FABBRO, M., RIVIERE, A., KHAYAT, D., BLEIBERG, H., FARALDI, M. and CLAVERIE, N., 1996, A double-blind, randomised comparison of the anti-emetic efficacy of two intravenous doses of dolasetron mesilate and granisetron in patients receiving high dose cisplatin chemotherapy. European Journal of Cancer, 32A, 807-813.
3. BAARNHIELM, C., DAHLBACK, H. and SKANBERG, I., 1986, In vitro pharmacokinetics of felodipine predicted from in vitro studies in rat, dog and man. Acta Pharmacologica et Toxicologica, 59, 113-122.
4. 3 receptor antagonist MDL 73,147EF (Dolasetron mesilate) and MDL 74,156 in NG 108-15 neuroblastoma × glioma cells. European Journal of Pharmacology, 219, 9-13.
5. BOXENBAUM, H. 1982, Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. Journal of Pharmacokinetics and Biopharmaceutics, 10, 201-227.
6. BOXENBAUM, H., 1984, Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metabolism Reviews, 15, 1071-1121.
7. BOXENBAUM, H. and D'SOUZA, R. W., 1990, Interspecies pharmacokinetic scaling, biological design and neotensy. In Advances in Drug Research, edited by B. Testa (London: Academic), pp. 139-196.
8. BOXENBAUM, H. and DI LEA, C., 1995, First-time-in-human dose selection: allometric thoughts and perspectives. Journal of Clinical Pharmacology, 35, 957-966.
9. BOXENBAUM, H. and FERTIG, J. B., 1984, Scaling of antipyrine intrinsic clearance of unbound drug in 15 mammalian species. European Journal of Drug Metabolism and Pharmacokinetics, 9, 177-183.
10. BOXENBAUM, H., GILLESPIE, T., HECK, K. and HAHNE, W., 1992, Human dolasetron pharmacokinetics: I. Disposition following single dose intravenous administration to normal male subjects. Biopharmaceutics and Drug Disposition, 13, 693-701.
11. BOXENBAUM, H., GILLESPIE, T., HECK, K. and HAHNE, W., 1993, Human dolasetron pharmacokinetics: II. Absorption and disposition following single dose oral administration to normal male subjects. Biopharmaceutics and Drug Disposition, 14, 131-141.
12. CHIBA, M., FUJITA, S. and SUZUKI, T., 1990, Pharmacokinetic correlation between in vitro hepatic microsomal enzyme kinetics and in vivo metabolism of imipramine and desipramine in rats. Journal of Pharmaceutical Sciences, 79, 281-287.
13. CRUZE, C. A., KELM, G. R. and MEREDITH, M. P., 1995, Interspecies scaling of tebufelone pharmacokinetic data and application to preclinical toxicology. Pharmaceutical Research, 12, 895-901.
14. DAVIES, B. and MORRIS, T., 1993, Physiological parameters in laboratory animals and humans. Pharmaceutical Research, 10, 1093-1095.
15. DEDRICK, R. L., BISCHOFF, K. B. and ZAHARKO, D. S., 1970, Interspecies correlation of plasma concentration, history of methotrexate (NSC-740). Cancer Chemotherapy Report, 54, 95-101.
16. DOW, J. and BERG, C., 1995, Stereoselectivity of the carbonyl reduction of dolasetron in rats, dogs and humans. Chirality, 7, 342-348.
17. DOW, J., DI FRANCESCO, G. F. and BERG, C., 1996, Comparison of the pharmacokinetics of dolasetron and its major active metabolite reduced dolasetron in dog. Journal of Pharmaceutical Sciences, 85, 685-689.
18. 3 receptor antagonist. British Journal of Pharmacology, 107, 449P.
19. HAYES, K. A., BRENNAN, B., CHENERY, R. and HOUSTON, J. B., 1995, In vivo disposition of caffeine predicted from hepatic microsomal and hepatocyte data. Drug Metabolism and Disposition, 23, 349-353.
20. HOENER, B., 1994, Predicting the hepatic clearance of xenobiotics in humans from in vitro data. Biopharmaceutics and Drug Disposition, 15, 295-304.
21. HOUSTON, J. B., 1994, Utility of in vitro drug metabolism data in predicting in vivo metabolic clearance. Biochemical Pharmacology, 47, 1469-1479.
22. HUEBERT, N. D., SCHWARTZ, J.-J., HINZE, C. and HAEGELE, K. D., 1994, Bioavailability and the effect of food on the pharmacokinetics of dolasetron mesilate and its active metabolite, MDL74156, in man. British Journal of Clinical Pharmacology, 37, 120P-121P.
23. HUEBERT, N. D., SCHWARTZ, J.-J., ZEIDLER, L., SCHWACH, V. and HAEGELE, K. D., 1996, Simultaneous measurement of dolasetron and its major metabolite, MDL74156, in human plasma and urine. Journal of Chromatography B: Biomedical Applications (in press).
24. HUSSEY, E. K., DONN, K. H., DANIEL, M. J., HALL, S. T., HARKER, A. J. and EVANS, G. L., 1994, Interspecies scaling and pharmacokinetic parameters of 3TC in humans. Journal of Clinical Pharmacology, 34, 975-977.
25. INGS, R. M. J., 1990, Interspecies scaling and comparisons in drug development and toxicokinetics. Xenobiotica, 20, 1201-1231.
26. KRIS, M. G., GRUNBERG, S. M., GRALLA, R. J., BALTZER, L., ZARETSKY, S., LIFSEY, D., TYSON, L. B., SCHMIDT, L. and HAHNE, W. F., 1994, Dose-ranging evaluation of the serotonin antagonist dolasetron mesylate in patients receiving high-dose cisplatin. Journal of Clinical Oncology, 12, 1045-1049.
27. LAVE, T., SCHMITT-HOFFMANN, A. H., COASSOLO, P., VALLES, B., UBEAUD, G., BA, B., BRANDT, R. and CHOU, R. C., 1995, A new extrapolation method from animal to man: application to a metabolized compound, mofarotene. Life Sciences, 56, 473-478.
28. LAVE, T., COASSOLO, P., UBEAUD, G., BRANDT, R., SCHMITT, C., DUPIN, S., JAECK, D. and CHOU, R. C., 1996a, Interspecies scaling of Bosentan, a new endothelin receptor antagonist and integration of in vitro data into allometric scaling. Pharmaceutical Research 13, 97-101.
29. LAVE, T., DUPIN, S., SCHMITT, M. et al., 1996b, Interspecies scaling of tolcapone, a new inhibitor of catechol-O-methyltransferase (COMT). Use of in vitro data from hepatocytes to predict metabolic clearance in animals and humans. Xenobiotica, 26, 839-851.
30. MAHMOOD, I. and BALIAN, J. D., 1996, Interspecies scaling: predicting pharmacokinetic parameters of antiepileptic drugs in humans from animals with special emphasis on clearance. Journal of Pharmaceutical Sciences, 85, 411-414.
31. MORDENTI, J., 1986, Man versus beast: pharmacokinetic scaling in mammals. Journal of Pharmaceutical Sciences, 75, 1028-1040.
32. RANE, A., WILKINSON, G. R. and SHAND, D. G., 1977, Prediction of hepatic extraction ratio from in vitro measurement of intrinsic clearance. Journal of Pharmacology and Experimental Therapeutics, 200, 420-424.
33. 3 receptor antagonist. Drug Metabolism and Disposition, 23, 806-812.
34. 3 antagonists. Drug Metabolism and Disposition, 24, 602-609.
35. SANWALD, P., DAVID, M. and DOW, J., 1996b, The use of electrospray ionization-liquid chromatography-mass spectrometry to study the role of CYP2D6 in the in vitro metabolism of 5-hydroxytryptamine receptor antagonists. Journal of Chromatography B: Biomedical Applications, 678, 53-61.
36. SANWALD, P., HUEBERT, N. D. and HAEGELE, K. D., 1994, Simultaneous measurement of the major metabolites of dolasetron mesilate in human urine using solid-phase extraction and high-performance liquid chromatography. Journal of Chromatography B: Biomedical Applications, 661, 101-107.
37. SAWADA, Y., HANANO, M., SUGIYAMA, Y. and IGA, T., 1984, Prediction of the disposition of beta-lactam antibiotics in humans from pharmacokinetic parameters in animals. Journal of Pharmacokinetics and Biopharmaceutics, 12, 241-261.
38. UBEAUD, G., SCHMITT, C., JAECK, D., LAVE, T. and COASSOLO, P., 1995, Bosentran, a new endothelin receptor antagonist: prediction of the systemic plasma clearance in man from combined in vitro and in vivo data. Xenobiotica, 25, 1381-1390.
39. WILKINSON, G. R., and SHAND, D. G., 1975, A physiological approach to hepatic drug clearance. Clinical Pharmacology and Therapeutics, 18, 377-390.
40. ZOMORODI, K., CARLILE, D. J. and HOUSTON, J. B., 1995, Kinetics of diazepam metabolism in rat hepatic microsomes and hepatocytes and their use in predicting in vivo hepatic clearance. Xenobiotica, 25, 907-916.