Follow-up to the pre-validation of a harmonised protocol for assessment of CYP induction responses in freshly isolated and cryopreserved human hepatocytes with respect to culture format, treatment, positive reference inducers and incubation conditions

Toxicology in Vitro

Volumn 24, Issue 1, 2010, Pages 346-356

  Abadie Viollon, Catherine ^a   Martin, Hélène ^b   Blanchard, Nadège ^a   Pekthong, Dumrongsak ^c   Bachellier, Philippe ^d   Mantion, Georges ^e   Heyd, Bruno ^e   Schuler, Frantz ^f   Coassolo, Philippe ^f   Alexandre, Eliane ^a   Richert, Lysiane ^a,b  

^a KaLy Cell   (France)

^b UNIVERSITÉ DE FRANCHE COMTÉ   (France)

^c NARESUAN UNIVERSITY   (Thailand)

^d HÔPITAL DE HAUTEPIERRE   (France)

^e UNIVERSITY HOSPITAL JEAN MINJOZ   (France)

^f F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

CYP induction; fresh and cryopreserved cells; harmonized protocol; human hepatocyte cultures

Indexed keywords

BETA NAPHTHOFLAVONE; CYTOCHROME P450; CYTOCHROME P450 1A2; CYTOCHROME P450 2B6; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; OMEPRAZOLE; PHENOBARBITAL; RIFAMPICIN;

ADULT; AGED; ANIMAL CELL; ARTICLE; CELL ISOLATION; CLINICAL ARTICLE; CONTROLLED STUDY; CRYOPRESERVATION; CULTURE TECHNIQUE; ENZYME INDUCTION; FEMALE; FOLLOW UP; HUMAN; HUMAN CELL; LABORATORY TEST; LIVER CELL CULTURE; MALE; NONHUMAN; RAT; VALIDATION PROCESS;

ADULT; AGED; ANTIBIOTICS, ANTITUBERCULAR; BETA-NAPHTHOFLAVONE; CELL CULTURE TECHNIQUES; CELL SEPARATION; CRYOPRESERVATION; CYTOCHROME P-450 ENZYME SYSTEM; ENZYME INDUCTION; ENZYME INHIBITORS; FEMALE; FOLLOW-UP STUDIES; HEPATOCYTES; HUMANS; INDICATORS AND REAGENTS; ISOENZYMES; MALE; MIDDLE AGED; OMEPRAZOLE; PHENOBARBITAL; PROTON PUMP INHIBITORS; REFERENCE STANDARDS; RIFAMPIN; RNA, MESSENGER; YOUNG ADULT;

EID: 72149107859     PISSN: 08872333     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tiv.2009.05.021     Document Type: Article

References (38)

1. Alexandre E., Cahn M., Abadie-Viollon C., Meyer N., Heyd N., Mantion G., Cinqualbre J., David P., Jaeck D., and Richert L. Influence of pre-, intra- and post-operative parameters of donor liver on the outcome of isolated human hepatocytes. Cell and Tissue Banking 3 (2002) 223-233
2. Bjornsson T.D., Callaghan J.T., Einolf H.J., Fischer V., Gan L., Grimm S., Kao J., King S.P., Miwa G., Ni L., Kumar G., McLeod J., Obach S.R., Roberts S., Roe A., Shah A., Snikeris F., Sullivan J.T., Tweedie D., Vega J.M., Walsh J., and Wrighton S.A. Pharmaceutical research and manufacturers of America drug metabolism/clinical pharmacology technical working groups. The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective. Journal of Clinical Pharmacology 43 5 (2003) 443-469
3. Curi-Pedrosa R., Daujat M., Pichard L., Ourlin J.C., Clair P., Gervot L., Lesca P., Domergue J., Joyeux H., and Fourtanier G. Omeprazole and lansoprazole are mixed inducers of CYP1A and CYP3A in human hepatocytes in primary culture. Journal of Pharmacology and Experimental Therapeutics 269 1 (1994) 384-392
4. Drocourt L., Pascussi J.M., Assenat E., Fabre J.M., Maurel P., and Vilarem M.J. Calcium channel modulators of the dihydropyridine family are human pregnane X receptor activators and inducers of CYP3A, CYP2B, and CYP2C in human hepatocytes. Drug Metabolism and Disposition 29 10 (2001) 1325-1331
5. Faucette S.R., Hawke R.L., LeCluyse E.L., Shord S.S., Yan B., Laethem R.M., and Lindley C.M. Validation of bupropion hydroxylation as a selective marker of human cytochrome P450 2B6 catalytic activity. Drug Metabolism and Disposition 28 (2000) 1222-1230
6. Faucette S.R., Wang H., Hamilton G.A., Jolley S.L., Gilbert D., Lindley C., Yan B., Negishi M., and LeCluyse E.L. Regulation of CYP2B6 in primary human hepatocytes by prototypical inducers. Drug Metabolism and Disposition 32 (2004) 348-358
7. Faucette S.R., Sueyoshi T., Smith C.M., Negishi M., LeCluyse E.L., and Wang H. Differential regulation of hepatic CYP2B6 and CYP3A4 genes by constitutive androstane receptor but not pregnane X receptor. Journal of Pharmacology and Experimental Toxicology 317 (2006) 1200-1209
8. Guillouzo A. Use of isolated and cultured hepatocytes for xenobiotics and cytotoxicity studies. In: Guillouzo A., and Guguen-Guillouzo C. (Eds). Isolated and Cultured Hepatocytes, Chapter 14 (1986), John Libbey Eurotext Ltd./INSERM, Paris 313-332
9. Hamilton G.A., Jolley S., Gilbert D., Coon D.J., Barros S.L., and LeCluyse E.L. Regulation of cell morphology and cytochrome P450 expression in human hepatocytes by extracellular matrix and cell-cell interactions. Cell Tissue Research 306 (2001) 85-99
10. Heimark L.D., Gibaldi M., Trager W.F., O'Reilly R.A., and Goulart D.A. The mechanism of the warfarin-rifampin drug interaction in humans. Clinical Pharmacology and Therapeutics 42 4 (1987) 388-394
11. Hewitt N.J., Lechón M.J., Houston J.B., Hallifax D., Brown H.S., Maurel P., Kenna J.G., Gustavsson L., Lohmann C., Skonberg C., Guillouzo A., Tuschl G., Li A.P., LeCluyse E., Groothuis G.M., and Hengstler J.G. Primary hepatocytes: current understanding of the regulation of metabolic enzymes and transporter proteins, and pharmaceutical practice for the use of hepatocytes in metabolism, enzyme induction, transporter, clearance, and hepatotoxicity studies. Drug Metabolism Reviews 39 1 (2007) 159-234
12. Hewitt N.J., Lecluyse E.L., and Ferguson S.S. Induction of hepatic cytochrome P450 enzymes: methods, mechanisms, recommendations, and in vitro-in vivo correlations. Xenobiotica 37 10-11 (2007) 1196-1224
13. Hewitt N.J., de Kanter R., and LeCluyse E. Induction of drug metabolizing enzymes: a survey of in vitro methodologies and interpretations used in the pharmaceutical industry - Do they comply with FDA recommendations?. Chemico-Biological Interactions 168 1 (2007) 51-65
14. Huang, S.-M., 2004. Drug interaction studies - Study design, data analysis, and implications for dosing and labelling. Preliminary Concept Paper, October 2004.
15. Huang, S.-M., Stifano, T., 2006. Guidance for Industry: Drug interaction studies - Study design, data analysis, and implications for dosing and labelling. Draft Guidance, September, 2006. .
16. Isom H.C., and Georgoff I. Quantitative assay for albumin-producing liver cells after simian virus 40 transformation of rat hepatocytes maintained in chemically defined medium. Proceedings of the National Academy of Science, USA 81 20 (1984) 6378-6382
17. LeCluyse E.L. Human hepatocyte culture systems for the in vitro evaluation of cytochrome P450 expression and regulation. European Journal of Pharmaceutical Sciences 13 4 (2001) 343-368
18. LeCluyse E.L., Madan A., Hamilton G., Carroll K., Dehaan R., and Parkinson A. Expression and regulation of cytochrome P450 enzymes in primary cultures of human hepatocytes. Journal of Biochemistry and Molecular Toxicology 14 (2000) 177-188
19. LeCluyse E.L., Alexandre E., Hamilton G.A., Abadie-Viollon C., Coon D.J., Jolley S., and Richert L. Isolation and culture of primary human hepatocytes. In: Helgason C.D., and Miller C.L. (Eds). Methods in Cell Biology: Basic Cell Culture Protocols, Chapter 15 vol. 290 (2005), Humana Press, Inc Totowa, NJ 207-229
20. Lin J.H. CYP induction-mediated drug interactions: in vitro assessment and clinical implications. Pharmaceutical Research 23 6 (2006) 1089-1116
21. Madan A., Graham R.A., Carroll K.M., Mudra D.R., Burton L.A., Krueger L.A., Downey A.D., Czerwinski M., Forster J., Ribadeneira M.D., Gan L.S., LeCluyse E.L., Zech K., Robertson P., Koch P., Antonian L., Wagner G., Yu L., and Parkinson A. Effects of prototypical microsomal enzyme inducers on cytochrome P450 expression in cultured human hepatocytes. Drug Metabolism and Disposition 31 (2003) 421-431
22. Maurel P. The use of adult human hepatocytes in primary culture and other in vitro systems to investigate drug metabolism in man. Advanced Drug Delivery Reviews 22 (1996) 105-132
23. Park J.Y., Kim K.A., Kang M.H., Kim S.L., and Shin J.G. Effect of rifampin on the pharmacokinetics of rosiglitazone in healthy subjects. Clinical Pharmacology and Therapeutics 75 3 (2004) 157-162
24. Parkinson A., Mudra D.R., Johnson C., Dwyer A., and Carroll K.M. The effects of gender, age, ethnicity, and liver cirrhosis on cytochrome P450 enzyme activity in human liver microsomes and inducibility in cultured human hepatocytes. Toxicology and Applied Pharmacology 199 (2004) 193-209
25. Richert L., Binda D., Hamilton G., Abadie-Viollon C., Alexandre E., Bigot-Lasserre D., Bars R., Coassolo P., and LeCluyse E. Evaluation of the effect of culture configuration on morphology, survival, antioxidant status and metabolic capacities of cultured rat hepatocytes. Toxicology in Vitro 16 (2002) 89-99
26. Richert L., Alexandre E., Lloyd T., Orr S., Abadie-Viollon C., Patel R., Kingston K., Berry D., Dennison A., Heyd H., Mantion G., and Jaeck D. Tissue collection, transport and isolation procedures required to optimize human hepatocyte isolation from waste liver surgical resections. Liver International 24 (2004) 371-378
27. Richert L., Tuschl G., Abadie C., Blanchard N., Pekthong D., Mantion G., Weber J.C., and Mueller S.O. Use of mRNA expression to detect the induction of drug metabolising enzymes in rat and human hepatocytes. Toxicology and Applied Pharmacology 235 (2009) 86-96
28. Richert L., Abadie C., Bonet A., Heyd B., Mantion G., Alexandre E., Bachellier P., Jaeck D., Kingston S., Pattenden C., Illouz S., Dennison A., Hoffmann S., and Coecke S. Inter-laboratory evaluation of the response of primary human hepatocyte cultures to model CYP inducers - A European Centre for Validation of Alternative Methods (ECVAM) - funded pre-validation study. Toxicology in Vitro 24 (2009) 335-345
29. Robertson P., Decory H.H., Madan A., and Parkinson A. In vitro inhibition and induction of human hepatic cytochrome P450 enzymes by modafinil. Drug Metabolism and Disposition 28 (2000) 664-671
30. Rost K.L., and Roots I. Accelerated caffeine metabolism after omeprazole treatment is indicated by urinary metabolite ratios: coincidence with plasma clearance and breath test. Clinical Pharmacology and Therapeutics 55 4 (1994) 402-411
31. Rost K.L., Brosicke H., Scheffler M., and Roots I. Dose dependent induction of CYP1A2 activity by omeprazole (Antra). International Journal of Clinical Pharmacology and Therapeutic Toxicology 30 11 (1992) 542-543
32. Roymans D., Annaert P., Van Houdt J., Weygers A., Noukens J., Sensenhauser C., Silva J., Van Looveren C., Hendrickx J., Mannens G., and Meuldermans W. Expression and induction potential of cytochromes P450 in human cryopreserved hepatocytes. Drug Metabolism and Disposition 33 7 (2005) 1004-1016
33. Shimada T., Yamazaki H., Mimura M., Inui Y., and Guengerich F.P. Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: studies with liver microsomes of 30 Japanese and 30 Caucasians. Journal of Pharmacology and Experimental Therapeutics 270 1 (1994) 414-423
34. Vind C., Dich J., and Grunnet N. Effects of cytochrome P450-inducing agents on the monooxygenation of testosterone in long-term cultures of hepatocytes from male and female rats. Archives of Biochemistry and Biophysics 275 1 (1989) 140-150
35. Wang H., Faucette S.R., Gilbert D., Jolley S.L., Sueyoshi T., Negishi M., and LeCluyse E.L. Glucocorticoid receptor enhancement of pregnane X receptor-mediated CYP2B6 regulation in primary human hepatocytes. Drug Metabolism and Disposition 31 5 (2003) 620-630
36. Wortelboer H.M., de Kruif C.A., van Iersel A.A., Falke H.E., Noordhoek J., and Blaauboer B.J. The isoenzyme pattern of cytochrome P450 in rat hepatocytes in primary culture, comparing different enzyme activities in microsomal incubations and in intact monolayers. Biochemical Pharmacology 40 11 (1990) 2525-2534
37. Xie W., Barwick J.L., Simon C.M., Pierce A.M., Safe S., Blumberg B., Guzelian P.S., and Evans R.M. Reciprocal activation of xenobiotic response genes by nuclear receptors SXR/PXR and CAR. Genes Development 14 23 (2000) 3014-3023
38. Zuber R., Anzenbacherova E., and Anzenbacher P. Cytochromes P450 and experimental models of drug metabolism. Journal of Cellular and Molecular Medicine 6 2 (2002) 189-198