Toxicokinetics and metabolism

ATLA Alternatives to Laboratory Animals

Volumn 33, Issue SUPPL. 1, 2005, Pages 147-175

  Coecke, Sandra ^a   Blaauboer, Bas J ^b   Elaut, Greetje ^c   Freeman, Stuart ^d   Freidig, Andreas ^e   Gensmantel, Nigel ^f   Hoet, Peter ^g   Kapoulas, Vassilios M ^h   Ladstetter, Bernhard ⁱ   Langley, Gill ^j   Leahy, David ^k   Mannens, Geert ^l   Meneguz, Annarita ^m   Monshouwer, Mario ⁿ   Nemery, Ben ^g   Pelkonen, Olavi ^o   Pfaller, Walter ^p   Prieto, Pilar ^a   Proctor, Nick ^q   Rogiers, Vera ^c   Rostami Hodjegan, Amin ^q   Sabbioni, Enrico ^a   Steiling, Winfried ^r   Van De Sandt, Johannes J M ^e   more..

^a JOINT RESEARCH CENTRE   (Italy)

^b UTRECHT UNIVERSITY   (Netherlands)

^c VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

^d GLAXOSMITHKLINE   (United Kingdom)

^e TNO   (Netherlands)

^f ASTRAZENECA   (United Kingdom)

^g UNIVERSITY OF LEUVEN   (Belgium)

^h Merck KgaA ^*

ⁱ MERCK KGAA   (Germany)

^j Dr Hadwen Trust   (United Kingdom)

^k CYPROTEX DISCOVERY LTD   (United Kingdom)

^l JANSSEN RESEARCH FOUNDATION   (Belgium)

^m ISTITUTO SUPERIORE DI SANITÀ   (Italy)

ⁿ PFIZER INC   (United States)

^o UNIVERSITY OF OULU   (Finland)

^p UNIVERSITY OF INNSBRUCK   (Austria)

^q UNIVERSITY OF SHEFFIELD   (United Kingdom)

^r HENKEL KGAA   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

COSMETIC;

ACUTE TOXICITY; ARTIFICIAL MEMBRANE; BIOAVAILABILITY; BIOTRANSFORMATION; CARCINOGENICITY; CELL LINE; CELL STRAIN CACO 2; COMPUTER MODEL; CONCENTRATION RESPONSE; ELECTRIC RESISTANCE; EYE IRRITATION; GENOTOXICITY; HUMAN; METABOLISM; NONHUMAN; PHOTOTOXICITY; PLASMA PROTEIN BINDING; PRACTICE GUIDELINE; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; REVIEW; SKIN ABSORPTION; SKIN SENSITIZATION; SPECIES DIFFERENCE; TOXICOKINETICS; VALIDATION PROCESS;

EID: 22844438986     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119290503301s15     Document Type: Review

References (73)

1. Bergstrom, C.A., Strafford, M., Lazorova, L., Avdeef, A., Luthman, K. & Artursson, P. (2003). Absorption classification of oral drugs based on molecular surface properties. Journal of Medicinal Chemistry 46, 558-70.
2. Chantret, I., Rodolosse, A., Barbat, A., Dussaulx, E., Brot-Laroche, E., Zweibaum, A. & Rousset, M. (1994). Differential expression of sucrose-isomaltase in clones isolated from early and late passages of the cell line Caco-2: evidence for glucose-dependent negative regulation. Journal of Cell Science 107, 213-225
3. Fogh, J., Wright, W.C. & Loveless, J.D. (1977). Absence of Hela cell contamination in 169 cell lines derived from human tumors. Journal of the National Cancer Institute 129, 1269-1277.
4. Gres, M.C., Julian, B., Bourrie, M., Meunier, V., Roques, C., Berger, M., Boulnec, X., Berger, Y. & Fahre, G. (1998). Correlation between oral drug absorption in humans, and apparent drug permeability in TC7 cells, a human epithelial intestinal cell line: comparison with the parenteral Caco-2 cell line. Pharmaceutical Research 15, 726-733.
5. Kuresh, A.Y., Avdeef, A. & Abbott, N.J. (2003). In vitro trans-monolayer permeability calculations: often forgotten assumptions. Drug Discovery Today 21, 997-1003.
6. Le Ferrec, E., Chesne, C., Artursson, P., Brayden, D., Fabre, G., Gires, P., Guillou, F., Rousset, M., Rubas, W. & Scarino, M-L. (2001). In vitro models of the intestinal barrier. The report and recommendations of ECVAM workshop 46. ATLA 29, 649-668.
7. Li, A.P. (2001). Screening for human ADME/Tox drug proteins in drug discovery. Drug Discovery Today 6, 357-366.
8. Pelkonen, O., Boobis, R.B. & Gundert-Remy, U. (2001). In vitro prediction of gastrointestinal absorption and bioavailability: an experts' meeting report. European Journal of Clinical Pharmacology 57, 621-629.
9. Tavelin, S., Taipalensuu, J., Soderberg, L., Morrison, R., Chong, S. & Artursson, P. (2003). Prediction of the oral absorption of low-permeability drugs using small intestine-like 2/4/A1 cell monolayers. Pharmaceutical Research 20, 397-405.
10. Kansy, M., Senner, F. & Gubernator, K. (1998). Physicochemical high throughput screening: parallel artificial membrane permeation assay in the description of passive absorption processes. Journal of Medicinal Chemistry 41, 1007-1010.
11. Sugano, K., Takata, N., Machida, M., Saitoh, K. & Terada, K. (2002). Prediction of passive intestinal absorption using bio-mimetic artificial membrane permeation assay and the paracellular pathway model. The International Journal of Pharmacy Practice 241, 241-251.
12. Andersen, M.E., Green, T., Frederick, C.B. & Bogdanffy, M.S. (2002). Physiologically based pharmacokinetic (PBPK) models for nasal tissue dosimetry of organic esters: assessing the state-of-knowledge and risk assessment applications with methyl methacrylate and vinyl acetate. Regulatory Toxicology and Pharmacology 36, 234-245.
13. Blaauboer, B.J. (2002). The necessity of biokinetic information in the interpretation of in vitro toxicity data. ATLA 30, 85-91.
14. De Jongh, J., Verhaar, H.J. & Hermens, J.L. (1998). Role of kinetics in acute lethality of nonreactive volatile organic compounds (VOCs). Toxicological Sciences 45, 26-32.
15. Frederick, C.B. (1995). Summary of panel discussion on the 'advantages/limitations/uncertainties in the use of physiologically based pharmacokinetic and pharmacodynamic models in hazard identification and risk assessment of toxic substances'. Toxicology Letters 79, 201-206.
16. Frederick, C.B., Lomax, L.G., Black, K.A., Finch, L., Scribner, H.E., Kimbell, J.S., Morgan, K.T., Subramaniam, R.P. & Morris, J.B. (2002). Use of a hybrid computational fluid dynamics and physiologically based inhalation model for interspecies dosimetry comparisons of ester vapors. Toxicology and Applied Pharmacology 183, 23-40.
17. Vanoirbeek, J.A., Mandervelt, C., Cunningham, A.R., Hoet, P.H., Xu, H., Vanhooren, H.M. & Nemery, B. (2003). Validity of methods to predict the respiratory sensitizing potential of chemicals: A study with a piperidinyl chlorotriazine derivative that caused an outbreak of occupational asthma. Toxicological Sciences 76, 338-346.
18. Agu, R.U., Jorissen, M., Willems, T., Augustijns, P., Kinget, R. & Verbeke, N. (2001). In vitro nasal drug delivery studies: comparison of derivatised, fibrillar and polymerised collagen matrix-based human nasal primary culture systems for nasal drug delivery studies. Journal of Pharmacy and Pharmacology 53, 1447-1456.
19. Foster, K.A., Yazdanian, M. & Audus, K.L. (2001). Microparticulate uptake mechanisms of in vitro cell culture models of the respiratory epithelium. Journal of Pharmacy and Pharmacology 53, 57-66.
20. Foster, K.A., Avery, M.L., Yazdanian, M. & Audus, K.L. (2000). Characterization of the Calu-3 cell line as a tool to screen pulmonary drug delivery. The International Journal of Pharmacy Practice 208, 1-11.
21. Forbes, I.I. (2000). Human airway epithelial cell lines for in vitro drug transport and metabolism studies. Pharmaceutical Science & Technology Today 3, 18-27.
22. Hamilton, K.O., Backstrom, G., Yazdanian, M.A. & Audus, K.L. (2001). P-glycoprotein efflux pump expression and activity in Calu-3 cells. Journal of Pharmaceutical Sciences 90, 647-658.
23. Nemmar, A., Hoet, P.H., Vanquickenborne, B., Dinsdale, D., Thomeer, M., Hoylaerts, M.F., Vanbilloen, H., Mortelmans, L. & Nemery, B. (2002). Passage of inhaled particles into the blood circulation in humans. Circulation 105, 411-414.
24. Xu, H., Hoet, P.H. & Nemery, B.J. (2002). In vitro toxicity assessment of polyvinyl chloride particles and comparison of six cellular systems. Journal of Toxicology and Environmental Health 65, 1141-1159.
25. Hukkanen, J., Lassila, A., Päivärinta, K., Valanne, S., Sarpo, S., Hakkola, J., Pelkonen, O. & Raunio, H. (2000). Induction and regulation of xenobiotic-metabolising cytochrome P450s in human A549 lung adenocarcinoma cells. American Journal of Respiratory Cell and Molecular Biology 22, 360-366.
26. MatTek's EpiAirway.™ Website http://www.mattek. com/pages/products/epiairway (Accessed 30.09.04).
27. Reconstituted human alveolar epithelium in vitro from Skinethic. Website http://www.skinethic.com (Accessed 30.09.04).
28. Banker, M.J., Clark, T.H. & Williams, J.A. (2003). Development and validation of a 96-well equilibrium dialysis apparatus for measuring plasma protein binding. Journal of Pharmaceutical Sciences 92, 967-974.
29. Fung, E.N., Chen, Y.H. & Lau, Y.Y. (2003). Semi-automatic high-throughput determination of plasma protein binding using a 96-well plate filtrate assembly and fast liquid chromatography-tandem mass spectrometry. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences 795, 187-94.
30. Kariv, I., Cao, H. & Oldenburg, K.R. (2001). Development of a high throughput equilibrium dialysis method. Journal of Pharmaceutical Sciences 90, 580-587.
31. Pacifici, G.M. & Viani, A. (1992). Methods of determining plasma and tissue binding of drugs. Pharmacokinetic consequences. Clinical Pharmacokinetics 23, 449-468.
32. Rich, R.L., Day, Y.S., Morton, T.A. & Myszka, D.G. (2001). High-resolution and high-throughput protocols for measuring drug/human serum albumin interactions using BIACORE. Analytical Biochemistry 296, 197-207.
33. Gargas, M.L., Burgess, R.J., Voisard, D.E., Cason, G.H. & Andersen, M.E. (1989). Partition coefficients of low-molecular-weight volatile chemicals in various liquids and tissues. Toxicology and Applied Pharmacology 98, 87-99.
34. Artola-Garicano, E., Vaes, W.H. & Hermens, J.L. (2000). Validation of negligible depletion solid-phase microextraction as a tool to determine tissue/blood partition coefficients for semivolatile and non-volatile organic chemicals. Toxicology and Applied Pharmacology 166, 138-144.
35. Jepson, G.W., Hoover, D.K., Black, R.K., McCafferty, J.D., Mahle, D.A. & Gearhart, J.M. (1994). A partition coefficient determination method for non-volatile chemicals in biological tissues. Fundamental and Applied Toxicology 22, 519-524.
36. Mattie, D.R., Bates, G.D., Jr, Jepson, G.W., Fisher, J.W. & McDougal, J.N. (1994). Determination of skin: air partition coefficients for volatile chemicals experimental method and applications. Fundamental and Applied Toxicology 22, 51-57.
37. Poulin, P. & Theil, F.P. (2002). Prediction of pharmacokinetics prior to in vivo studies. 1. Mechanism-based prediction of volume of distribution. Journal of Pharmaceutical Sciences 91, 129-156.
38. Bertrand, M., Jackson, P. & Walther, B. (2000). Rapid assessment of drug metabolism in the drug discovery process. European Journal of Pharmaceutical Sciences 11, S61-S72.
39. Clarke, S.E. & Jeffrey, P. (2001). Utility of metabolic stability screening: comparison of in vitro and in vivo clearance. Xenobiotica 31, 591-598.
40. Elaut, G., Papeleu, P., Rogiers, V. & Vanhaecke, T. (2002). Practical aspects of in vitro biotransformation studies during early drug development. In Recent Research and Develelopments in Drug Metabolism and Disposition (ed. S.G. Pandalai), pp. 167-198. Kerala, India: Transworld Research Network.
41. Gebhardt, R., Hengstler, J.G., Müller, D., Glöckner, R., Buenning, P., Laube, B., Schmelzer, E., Ullrich, M., Utesch, D., Hewitt, N., Ringel, M., Hilz, B.R., Bader, A., Langsch, A., Koose, T., Burger, H.J., Maas, J. & Oesch, F. (2003). New hepatocyte in vitro systems for drug metabolism: metabolic capacity and recommendations for application in basic research and drug development, standard operation procedures. Drug Metabolism Reviews 35, 145-213.
42. Li, A.P. (2001). Screening for ADME/Tox properties in drug discovery. Drug Discovery Today 6, 357-366.
43. Masimirembwa, C.M., Bredberg, U. & Andersson, T.B. (2003). Metabolic stability for drug discovery and development: pharmacokinetic and biochemical challenges. Clinical Pharmacokinetics 42, 515-528.
44. Obach, R.S. (2001). The prediction of human clearance from hepatic microsomal metabolism data. Current Opinion in Drug Discovery & Development 4, 36-44.
45. Bull, S., Langezaal, I., Clothier, R. & Coecke, S. (2001). A Genetically engineered cell-based system for detecting metabolism-mediated toxicity. ATLA 29, 703-716.
46. Busby, W.F. Jr, Penman, B.W. & Crespi, C.L. (1994). Human cell mutagenicity of mono- and dinitropyrenes in metabolically competent MCL-5 cells. Mutation Research 322, 233-242.
47. Crespi (2003). The BD Gentest™ MCL-5 Metabo-Tox Assay Kit allows high throughput screening for potential P450 mediated toxicity in the early stages of drug discovery. Website http://www.gentest.com/products/HTS_KITS/ metabo_tox_assay_kit.shtm (Accessed 30.09.04).
48. Gomez-Lechon, M.J., Donato, M.T., Castell, J.V. & Jover, R. (2003). Human hepatocytes as a tool for studying toxicity and drug metabolism. Current Drug Metabolism 4, 292-312.
49. Papeleu, P., Elaut, G., Rogiers, V. & Vanhaecke, T. (2002). Cell cultures as in vitro tools for biotransformation studies. In Recent Research and Develelopments in Drug Metabolism and Disposition (ed. S.G. Pandalai), pp.199. Kerala, India: Transworld Research Network.
50. Peng, F.C., Tseng, H.Y., Tsai, J.C., Lin, C. & Doehmer, J. (2003). Role of human hepatic cytochrome P-450s in territrem A metabolism. Journal of Toxicology and Environmental Health. Part A. 66, 1237-1248.
51. Townsend, A.J., Kabler, S.L., Doehmer, J. & Morrow, C.S. (2002). Modeling the metabolic competency of glutathione S-transferases using genetically modified cell lines. Toxicology 181-182, 265-269.
52. Boobis, A., Gundert-Remy, U., Kremers, P., Macheras, P. & Pelkonen, O. (2002). In silico prediction of ADME and pharmacokinetics. Report of an expert meeting organised by COST B15. European Journal of Pharmaceutical Sciences 17, 183-193.
53. Langowski, J. & Long, A. (2002). Computer systems for the prediction of xenobiotic metabolism. Advanced Drug Delivery Reviews 54, 407-415.
54. van de Waterbeemd, H. & Gifford, E. (2003). ADMET in silico modelling: towards prediction paradise? Nature Reviews. Drug Discovery 2, 192-204.
55. Yu, H. & Adedoyin, A. (2003). ADME-Tox in drug discovery: integration of experimental and computational technologies. Drug Discovery Today 8, 854-861.
56. Lin, J.H. (1998). Applications and limitations of interspecies scaling and in vitro extrapolation in pharmacokinetics. Drug Metabolism and Disposition 26, 1202-1212.
57. Naritomi, Y., Terashita, S., Kimura, S., Suzuki, A., Kagayama, A. & 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 Metabolism and Disposition 29, 1316-1324.
58. Nestorov, I. (2003). Whole body pharmacokinetic models. Clinical Pharmacokinetics 42, 883-908.
59. Proctor, N.J., Rostami-Hodjegan, A. & Tucker, G.T. (2003). Sources of variability associated with quantitative predictions of drug clearance from recombinant CYP enzymes. Drug Metabolism Reviews 35, 202-210.
60. Proctor, N.J., Rostami-Hodjegan, A. & Tucker, G.T. (2003). In vitro prediction of population in vivo drug clearance using updated scaling factors. British Journal of Clinical Pharmacology 55, 445.
61. Proctor, N.J., Rostami-Hodjegan, A. & Tucker, G.T. (2003). ISEF: an intersystem extrapolation factor for use with recombinant cytochrome P450 expression systems. British Journal of Clinical Pharmacology 55, 437-438.
62. Proctor, N.J., Rostami-Hodjegan, A. & Tucker, G.T. (2004). Predicting drug clearance from recombinantly expressed CYPs: intersystem extrapolation factors. Xenobiotica 34, 151-178.
63. Sweeney, L.M. (2000). Comparing occupational and environmental risk assessment methodologies using pharmacokinetic modelling. Human and Ecological Risk Assessment 6, 1101-1124.
64. Andersen, M. (1995). Development of physiologically based pharmacokinetic and physiologically based pharmacodynamic models for application in toxicology and risk assessment. Toxicology Letters 82-83, 341-348.
65. Grass, G. (2002). Physiologically based pharmacokinetic simulation modelling. Advanced Drug Delivery Reviews 54, 433-451.
66. Leahy, D.E. (2003). Progress in simulation modelling for pharmacokinetics. Current Topics in Medicinal Chemistry 3, 1257-1268.
67. Yu, L.X. (1999). An integrated model for determining causes of poor oral drug absorption. Pharmaceutical Research 16, 1883-1887.
68. Barker, J. & Garner, R.C. (1999). Biomedical applications of accelerator mass spectrometry isotope measurements at the level of the atom. Rapid Communications in Mass Spectrometry 13, 285-293.
69. Combes, R.D., Berridge, M., Connelly, J., Eve, M.D., Garner, R.C., Toon, S. & Wilcox, P. (2003). Early microdose studies in human volunteers can minimise animal testing - Proceedings of a workshop organised by Volunteers in Research and Testing. European Journal of Pharmaceutical Sciences 19, 1-11.
70. Garner, R.C, Barker, J., Flavell, C., Garner, J.V., Whattam, M., Young, G.C., Cussans, N., Jezequel, S. & Leong, D. (2000). A validation study comparing accelerator MS and liquid scintillation counting for analysis of 14C-labelled drugs, in plasma, urine and faecal extracts. Journal of Pharmaceutical and Biomedical Analysis 24, 197-209.
71. Garner, R.C., Garner, J.V., Gregory, S., Whattam, M., Calam, A. & Leong, D. (2002). Comparison of absorption of micronized (Daflon 500mg) and non-micronized 14C-diosmin tablets after oral administration to healthy volunteers by accelerator mass spectrometry and liquid scintillation counting. Journal of Pharmaceutical Sciences 91, 32-40.
72. Vogel, J.S., Grant, P.G., Buchholz, B.A., Dinglery, K. & Turteltaub, K.W. (2001). Attomole quantitation of protein separations with accelerator mass spectrometry. Electrophoresis 22, 2037-2045.
73. Young, G., Ellis, W., Ayrton, J., Hussey, E. & Adamkiewicz, B. (2001). Accelerator mass spectrometry (AMS): recent experience of its use in a clinical study and the potential future of the technique. Xenobiotica 31, 619-632.