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MARÍA JOSÉ GÓMEZ-LECHÓN y MARÍA TERESA DONATO AN. R. ACAD. NAC. FARM.

(6) NAVARRO, V. J. and SENIOR, J. R. (2006): Drug-related hepatotoxicity. N. Engl.
(7) J. Med. 354: 731-739.
(8) FDA. Publications. Guidance for Industry, http://www.fda.gov/cder/guidance
(9) /cln3.pdf 1997 April. EMEA; http://www.emea.eu.int/ 1997 December.
(10) LIN, J.; SAHAKIAN, D. C.; DE MORAIS, S. M.; XU, J. J.; POLZER, R. J. and WINTER,
(11) S. M. (2003): The role of absorption, distribution, metabolism, excretion and
toxicity in drug discovery. Curr. Top. Med. Chem. 3: 1125-1154.
(12) DAMBACH, D. M.; ANDREWS, B. A. and MOULIN, F. (2005): New technologies and
(13) screening strategies for hepatotoxicity: use of in vitro models. Toxicol. Pathol.
33: 17-26.
(14) THOMPSON, T. N. (2000): Early ADME in support of drug discovery: the role
(15) of metabolic stability studies. Curr. Drug Metab. 1: 215-241.
(16) BARANCZEWSKI, P.; STANCZAK, A.; SUNDBERG, K.; SVENSSON, R.; WALLIN, A.; JANSSON,
J. and GARBERG, P. (2006): Postlind. Introduction to in vitro estimation of
(17) metabolic stability and drug interactions of new chemical entities in drug
discovery and development. Pharmacol. Rep. 58: 453-472.
(18) MASIMIREMBWA, C. M.; BREDBERG, U. and andERSSON, T. B. (2003): Metabolic
(19) stability for drug discovery and development: pharmacokinetic and
(20) biochemical challenges. Clin. Pharmacokinet. 42: 515-528.
KANTHARAJ, E.; TUYTELAARS, A.; PROOST, P. E.; ONGEL, Z.; VAN ASSOUW, H. P. and
GILISSEN, R. A. (2003): Simultaneous measurement of drug metabolic stability
and identification of metabolites using ion-trap mass spectrometry. Rapid
Commun. Mass Spectrom. 17: 2661-2668.
GÓMEZ-LECHÓN, M. J.; DONATO, M. T.; CASTELL, J. V. and JOVER, R. (2004):
Human hepatocytes in primary cultures: The choice to investigate drug
metabolism in man. Curr. Drug Metab. 5: 443-462.
LI, A. P. (2004): A comprehensive approach for drug safety assessment. Chem.
Biol. Interact. 150: 27-33.
GEBHARDT, R.; HENGSTLER, J. G.; MULLER, D.; GLOCKNER, 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. and 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 Metab. Rev. 35: 145-213.
REDDY, A.; HEIMBACH, T.; FREIWALD, S.; SMITH, D.; WINTERS, R.; MICHAEL, S.;
SURENDRAN, N. and CAI, H. (2005): Validation of a semi-automated human
hepatocyte assay for the determination and prediction of intrinsic clearance
in discovery. J. Pharm. Biomed. Anal. 37: 319-326.
LEWIS, D. F.; IOANNIDES, C. and PARKE, D. V. (1998): Cytochromes P450 and
species differences in xenobiotic metabolism and activation of carcinogen.
Env. Health Persp. 106: 633-641.
LIN, J. H. (1998): Applications and limitations of interspecies scaling and in
vitro extrapolation in pharmacokinetics. Drug. Metab. Dispos. 26: 1202-1212.
BUN, H.; DISDIER, B., AUBERT, C. and CATALIN, J. (1999): Interspecies variability
and drug interactions of clozapine metabolism by microsomes. Fundam. Clin.
Pharmacol. 13: 577-581.

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