PRINCIPLES OF TOXICOLOGY TESTING

Principles Of Toxicology Testing

Volumn , Issue , 2007, Pages 1-313

  Barile, Frank A ^a  

^a ST JOHN'S UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85153656539     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/9781420008326     Document Type: Book

References (506)

1. Abraham, J., The science and politics of medicines control, Drug Saf., 26, 135, 2003.
2. Bois, F.Y., Applications of population approaches in toxicology, Toxicol. Lett., 120, 385, 2001.
3. Eaton, D.L. and Klassen, C.D., Principles of toxicology, in Casarett and Doull’s Toxicology:The Basic Science of Poisons, Klassen, C.D., Ed., 6th ed., McGraw-Hill, New York, 2001, ch. 2.
4. Ettlin, R.A. et al., Careers in toxicology in Europe: options and requirements. Report of a workshop presented at the EUROTOX Congress in London (September 17-20, 2000), Arch. Toxicol., 75, 251, 2001.
5. Gennings, C., On testing for drug/chemical interactions: definitions and inference, J. Biopharm. Stat., 10, 457, 2000.
6. Greenberg, G., Internet resources for occupational and environmental health professionals, Toxicology, 178, 263, 2002.
7. Guzelian, P.S., Victoroff, M.S., Halmes, N.C., James, R.C., and Guzelian, C.P., Evidencebased toxicology: a comprehensive framework for causation, Hum. Exp. Toxicol. 24, 161, 2005.
8. Kaiser, J., Toxicology: tying genetics to the risk of environmental diseases, Science, 300, 563, 2003.
9. Meyer, O., Testing and assessment strategies including alternative and new approaches, Toxicol. Lett., 140, 2003.
10. Tennant, R.W., The National Center for Toxicogenomics: using new technologies to inform mechanistic toxicology, Environ. Health Perspect., 110, A8, 2002.
11. Aardema, M.J. and MacGregor, J.T., Toxicology and genetic toxicology in the new era of “toxicogenomics”: impact of "-omics” technologies, Mutat. Res., 499, 13, 2002.
12. Abraham, J. and Reed, T., Progress, innovation and regulatory science in drug development:the politics of international standard setting, Soc. Stud. Sci., 32, 337, 2002.
13. Barnard, R.C., Some regulatory definitions of risk: interaction of scientific and legal principles, Regul. Toxicol. Pharmacol., 11, 201, 1990.
14. Collins, T.F., History and evolution of reproductive and developmental toxicology guidelines, Curr. Pharm. Des. 12, 1449, 2006.
15. Eason, C. and O’Halloran, K., Biomarkers in toxicology versus ecological risk assessment, Toxicology, 181, 517, 2002.
16. Fostel, J. et al., Chemical effects in biological systems data dictionary (CEBS-DD): a compendium of terms for the capture and integration of biological study design description, conventional phenotypes, and “omics” data. Toxicol. Sci. 88, 585, 2005.
17. Harris, S.B. and Fan, A.M., Hot topics in toxicology, Int. J. Toxicol., 21, 383, 2002.
18. Johnson, D.E. and Wolfgang, G.H., Assessing the potential toxicity of new pharmaceuticals, Curr. Top. Med. Chem., 1, 233, 2001.
19. Lewis, R.W. et al., Recognition of adverse and nonadverse effects in toxicity studies, Toxicol. Pathol., 30, 66, 2002.
20. Reynolds, V.L., Applications of emerging technologies in toxicology and safety assessment, Int. J. Toxicol., 24, 135, 2005.
21. Rietjens, I.M. and Alink, G.M., Future of toxicology: low dose toxicology and risk-benefit analysis, Chem Res Toxicol. 19, 977, 2006.
22. Schrenk, D., Regulatory toxicology: objectives and tasks defined by the working group of the German society of experimental and clinical pharmacology and toxicology, Toxicol. Lett., 126, 167, 2002.
23. Waddell, W.J., The science of toxicology and its relevance to MCS, Regul. Toxicol. Pharmacol., 18, 13, 1993.
24. Wolfgang, G.H. and Johnson, D.E., Web resources for drug toxicity, Toxicology, 173, 67, 2002.
25. Acquavella, J. et al., Epidemiologic studies of occupational pesticide exposure and cancer:regulatory risk assessments and biologic plausibility, Ann. Epidemiol., 13, 1, 2003.
26. Ashby, J., The leading role and responsibility of the international scientific community in test development, Toxicol. Lett., 140, 37, 2003.
27. Carnevali, O. and Maradonna, F., Exposure to xenobiotic compounds: looking for new biomarkers, Gen. Comp. Endocrinol., 131, 203, 2003.
28. Eaton, D.L. and Klassen, C.D., Principles of toxicology, in Casarett and Doull’s Toxicology:The Basic Science of Poisons, Klaassen, C.D., Ed., 6th ed., McGraw-Hill, New York, 2001, Ch. 2.
29. Olsen, C.M., Meussen-Elholm, E.T., Hongslo, J.K., Stenersen, J., and Tollefsen, K.E., Estrogenic effects of environmental chemicals: an interspecies comparison. Comp. Biochem. Physiol. C Toxicol. Pharmacol. 141, 267, 2005.
30. Yang, A., Cardona, D.L., and Barile, F.A., Subacute cytotoxicity testing with cultured human lung cells, Toxicol. in Vitro, 16, 33, 2002.
31. Basketter, D.A. et al., Factors affecting thresholds in allergic contact dermatitis: safety and regulatory considerations, Contact Dermatitis, 47, 1, 2002.
32. Bolt, H.M. and Kiesswetter, E., Is multiple chemical sensitivity a clinically defined entity? Toxicol. Lett., 128, 99, 2002.
33. Dewhurst, I.C., Toxicological assessment of biological pesticides, Toxicol. Lett., 120, 67, 2001.
34. Edler, L. and Kopp-Schneider, A., Statistical models for low dose exposure, Mutat. Res., 405, 227, 1998.
35. Efroymson, R.A. and Murphy, D.L., Ecological risk assessment of multimedia hazardous air pollutants: estimating exposure and effects, Sci. Total Environ., 274, 219, 2001.
36. Feron, V.J. et al., International issues on human health effects of exposure to chemical mixtures, Environ. Health Perspect, 110, 893, 2002.
37. Foster, J.R., The functions of cytokines and their uses in toxicology, Int. J. Exp. Pathol., 82, 171, 2001.
38. Furtaw, E.J., Jr., An overview of human exposure modeling activities at the U.S. EPA’s National Exposure Research Laboratory, Toxicol. Ind. Health, 17, 302, 2001.
39. Gaylor, D.W. and Kodell, R.L., Dose-response trend tests for tumorigenesis adjusted for differences in survival and body weight across doses, Toxicol. Sci., 59, 219, 2001.
40. Goldman, L.R., Epidemiology in the regulatory arena, M. J. Epidemiol., 154, 18, 2001.
41. Green, S., Goldberg, A., and Zurlo, J., TestSmart high production volume chemicals: an approach to implementing alternatives into regulatory toxicology, Toxicol. Sci., 63, 6, 2001.
42. Hakkinen, P.J. and Green, D.K., Alternatives to animal testing: information resources via the Internet and World Wide Web, Toxicology, 173, 3, 2002.
43. Hanson, M.L. and Solomon, K.R., New technique for estimating thresholds of toxicity in ecological risk assessment, Environ. Sci. Technol., 36, 3257, 2002.
44. Hastings, K.L., Implications of the new FDA/CDER immunotoxicology guidance for drugs, Int. Immunopharmacol., 2, 1613, 2002.
45. Hattan, D.G. and Kahl, L.S., Current developments in food additive toxicology in the USA, Toxicology, 181, 417, 2002.
46. Herbarth, O. et al., Effect of sulfur dioxide and particulate pollutants on bronchitis in children:a risk analysis, Environ. Toxicol., 16, 269, 2001.
47. Isbister, G.K., Data collection in clinical toxinology: debunking myths and developing diagnostic algorithms, J. Toxicol. Clin. Toxicol., 40, 231, 2002.
48. Jarup, L., Health and environment information systems for exposure and disease mapping, and risk assessment. Environ. Health Perspect., 112, 995, 2004.
49. Kenna, L.A., Labbe, L., Barrett, J.S., and Pfister, M., Modeling and simulation of adherence:approaches and applications in therapeutics, AAPS J., 7, E390, 2005.
50. Kimber, I., Gerberick, G.F., and Basketter, D.A., Thresholds in contact sensitization: theoretical and practical considerations, Food Chem. Toxicol., 37, 553, 1999.
51. Krishnan, K. and Johanson, G., Physiologically-based pharmacokinetic and toxicokinetic models in cancer risk assessment. J. Environ. Sci. Health C Environ. Carcinog. Ecotoxicol. Rev., 23, 31, 2005.
52. Maurer, T., Skin as a target organ of immunotoxicity reactions, Dev. Toxicol. Environ. Sci., 12, 147, 1986.
53. McCarty, L.S., Issues at the interface between ecology and toxicology, Toxicology, 181, 497, 2002.
54. McCurdy, T. et al., The national exposure research laboratory’s consolidated human activity database, J. Expo. Anal. Environ. Epidemiol., 10, 566, 2000.
55. Melnick, R.L. and Kohn, M.C., Dose-response analyses of experimental cancer data, Drug Metab. Rev., 32, 193, 2000.
56. Moschandreas, D.J. and Saksena, S., Modeling exposure to particulate matter, Chemosphere, 49, 1137, 2002.
57. Moya, J. and Phillips, L., Overview of the use of the U.S. EPA exposure factors handbook, Int. J. Hyg. Environ. Health, 205, 155, 2002.
58. Mueller, S.O., Xenoestrogens: mechanisms of action and detection methods, Anal. Bioanal. Chem., 378, 582, 2004.
59. Palmer, J.R. et al., Risk of breast cancer in women exposed to diethylstilbestrol in utero:preliminary results (U.S.), Cancer Causes Control, 13, 753, 2002.
60. Pennington, D. et al., Assessing human health response in life cycle assessment using ED10s and DALYs: part 2, noncancer effects, Risk Anal., 22, 947, 2002.
61. Schneider, T. et al., Conceptual model for assessment of dermal exposure, Occup. Environ. Med., 56, 765, 1999.
62. Strickland, J.A. and Foureman, G.L., U.S. EPA’s acute reference exposure methodology for acute inhalation exposures, Sci. Total Environ., 288, 51, 2002.
63. Tanaka, E., Toxicological interactions between alcohol and benzodiazepines, J. Toxicol. Clin. Toxicol., 40, 69, 2002.
64. Wexler, P. and Phillips, S., Tools for clinical toxicology on the World Wide Web: review and scenario, J. Toxicol. Clin. Toxicol., 40, 893, 2002.
65. Kauffman, F.C., Sulfonation in pharmacology and toxicology, Drug Metab Rev., 36, 823, 2004.
66. Klaassen, C.D. and Slitt, A.L., Regulation of hepatic transporters by xenobiotic receptors, Curr. Drug Metab., 6, 309, 2005.
67. Medinsky, M.A. and Valentine, J.L., Principles of toxicology, in Casarett and Doull’s Toxicology:The Basic Science of Poisons, Klaassen, C.D., Ed., 6th ed., McGraw-Hill, New York, 2001, Ch. 7.
68. Norinder, U. and Bergstrom, C.A., Prediction of ADMET properties, Chem. Med. Chem.1, 920, 2006.
69. Rodriguez-Antona, C. and Ingelman-Sundberg, M., Cytochrome P450 pharmacogenetics and cancer, Oncogene, 25, 1679, 2006.
70. Strolin-Benedetti, M., Whomsley, R., and Baltes, E.L., Differences in absorption, distribution, metabolism and excretion of xenobiotics between the paediatric and adult populations, Expert Opin. Drug. Metab. Toxicol., 1, 447, 2005.
71. Urso, R., Blardi, P., and Giorgi, G., A short introduction to pharmacokinetics, Eur. Rev. Med. Pharmacol. Sci., 6, 33, 2002.
72. Wijnand, H.P., Pharmacokinetic model equations for the one- and two-compartment models with first-order processes in which the absorption and exponential elimination or distribution rate constants are equal, J. Pharmacokinet. Biopharm., 16, 109, 1988.
73. Barile, F.A., Dierickx, P.J., and Kristen, U., In vitro cytotoxicity testing for prediction of acute human toxicity, Cell Biol. Toxicol., 10, 155, 1994.
74. Bodo, A. et al., The role of multidrug transporters in drug availability, metabolism and toxicity, Toxicol. Lett., 140, 133, 2003.
75. Buchanan, J.R., Burka, L.T., and Melnick, R.L., Purpose and guidelines for toxicokinetic studies within the National Toxicology Program, Environ. Health Perspect., 105, 468, 1997.
76. Cascorbi, I., Genetic basis of toxic reactions to drugs and chemicals, Toxicol. Lett., 162, 16, Epub 2005
77. Dalvie, D., Recent advances in the applications of radioisotopes in drug metabolism, toxicology and pharmacokinetics, Curr. Pharm. Des., 6, 1009, 2000.
78. El-Tahtawy, A.A. et al., Evaluation of bioequivalence of highly variable drugs using clinical trial simulations II. Comparison of single and multiple-dose trials using AUC and Cmax, Pharm. Res., 15, 98, 1998.
79. Gamage, N. et al. Human sulfotransferases and their role in chemical metabolism, Toxicol Sci. 90, 5, Epub 2005.
80. Ikeda, M., Application of biological monitoring to the diagnosis of poisoning, J. Toxicol. Clin. Toxicol., 33, 617, 1995.
81. Ioannides, C. and Lewis, D.F., Cytochromes P450 in the bioactivation of chemicals, Curr. Top. Med. Chem., 4, 1767, 2004.
82. Ishii, K. et al., A new pharmacokinetic model including in vivo dissolution and gastrointestinal transit parameters, Biol. Pharm. Bull., 18, 882, 1995.
83. Krzyzanski, W. and Jusko, W.J., Mathematical formalism for the properties of four basic models of indirect pharmacodynamic responses, J. Pharmacokinet. Biopharm., 25, 107, 1997.
84. Lacey, L.F. et al., Evaluation of different indirect measures of rate of drug absorption in comparative pharmacokinetic studies, J. Pharm. Sci., 83, 212, 1994.
85. Lin, J.H., Species similarities and differences in pharmacokinetics, Drug Metab. Dispos., 23, 1008, 1995.
86. Lock, E.A. and Smith, L.L., The role of mode of action studies in extrapolating to human risks in toxicology, Toxicol. Lett., 140, 317, 2003.
87. Mahmood, I. and Miller, R., Comparison of the Bayesian approach and a limited sampling model for the estimation of AUC and Cmax: a computer simulation analysis, Int. J. Clin. Pharmacol. Ther., 37, 439, 1999.
88. Matthies, M., Exposure assessment of environmental organic chemicals at contaminated sites:a multicompartment modelling approach, Toxicol. Lett., 140, 367, 2003.
89. Meineke, I. and Gleiter, C.H., Assessment of drug accumulation in the evaluation of pharmacokinetic data, J. Clin. Pharmacol., 38, 680, 1998.
90. Myllynen, P., Pasanen, M., and Pelkonen, O., Human placenta: a human organ for developmental toxicology research and biomonitoring, Placenta, 26, 361, 2005.
91. Perri, D. et al., The kidney: the body’s playground for drugs: an overview of renal drug handling with selected clinical correlates, Can. J. Clin. Pharmacol., 10, 17, 2003.
92. Plusquellec, Y., Courbon, F., and Nogarede, S., Consequence of equal absorption, distribution and/or elimination rate constants, Eur. J. Drug Metab. Pharmacokinet., 24, 197, 1999.
93. Poulin, P. and Theil, F.P., Prediction of pharmacokinetics prior to studies II. Generic physiologically based pharmacokinetic models of drug disposition, J. Pharm. Sci., 91, 1358, 2002.
94. Ramanathan, M., Pharmacokinetic variability and therapeutic drug monitoring actions at steady state, Pharm. Res., 17, 589, 2000.
95. Repetto, M.R. and Repetto, M., Concentrations in human fluids: 101 drugs affecting the digestive system and metabolism, J. Toxicol. Clin. Toxicol., 37, 1, 1999.
96. Rogers, J.F., Nafziger, A.N., and Bertino, J.S., Jr., Pharmacogenetics affects dosing, efficacy, and toxicity of cytochrome P450-metabolized drugs, Am. J. Med., 113, 746, 2002.
97. Clarkson, T.W., Principles of risk assessment, Adv. Dent. Res., 6, 22, 1992.
98. Collins, T.F., History and evolution of reproductive and developmental toxicology guidelines, Curr. Pharm. Des., 12, 1449, 2006.
99. Cross, J. et al., Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, Pharmacoepidemiol. Drug Saf., 11, 439, 2002.
100. Dietz, F.K., Ramsey, J.C., and Watanabe, P.G., Relevance of experimental studies to human risk, Environ. Health Perspect., 52, 9, 1983.
101. Hays, S.M., Becker, R.A., Leung, H.W., Aylward, L.L., and Pyatt, D.W., Biomonitoring equivalents: a screening approach for interpreting biomonitoring results from a public health risk perspective, Regul. Toxicol. Pharmacol., 2006 [Epub ahead of print].
102. Luft, J. and Bode, G., Integration of safety pharmacology endpoints into toxicology studies, Fundam. Clin. Pharmacol., 16, 91, 2002.
103. Nicoll, A. and Murray, V., Health protection: strategy and a national agency, Publ.Health, 116, 129, 2002.
104. Patterson, J., Hakkinen, P.J., and Wullenweber, A.E., Human health risk assessment: selected Internet and world wide web resources, Toxicology, 173, 123, 2002.
105. Acquavella, J. et al., Epidemiologic studies of occupational pesticide exposure and cancer:regulatory risk assessments and biologic plausibility, Ann. Epidemiol., 13, 1, 2003.
106. Baht, R.V. and Moy, G.G., Monitoring and assessment of dietary exposure to chemical contaminants, World Health Stat. Q., 50, 132, 1997.
107. Barlow, S.M. et al., Hazard identification by methods of animal-based toxicology, Food Chem. Toxicol., 40, 145, 2002.
108. Bernauer, U., Oberemm, A., Madle, S., and Gundert-Remy, U., The use of in vitro data in risk assessment, Basic Clin. Pharmacol. Toxicol., 96, 176, 2005.
109. Boyes, W.K. et al., EPA’s neurotoxicity risk assessment guidelines, Fundam. Appl. Toxicol., 40, 175, 1997.
110. Buchanan, J.R., Burka, L.T., and Melnick, R.L., Purpose and guidelines for toxicokinetic studies within the National Toxicology Program, Environ. Health Perspect., 105, 468, 1997.
111. Bull, R.J., Conolly, R.B., De Marini, D.M., MacPhail, R.C., Ohanian, E.V., and Swenberg, J.A. Incorporating biologically based models into assessments of risk from chemical contaminants, J. Am. Water Works Assn., 85, 49, 1993.
112. Carere, A. and Benigni, R., Strategies and governmental regulations, Teratog. Carcinog. Mutagen, 10, 199, 1990.
113. Casciano, D.A., FDA: a science-based agency, FDA Consum., 36, 40, 2002.
114. Cimino, M.C., Comparative overview of current international strategies and guidelines for genetic toxicology testing for regulatory purposes, Environ. Mol. Mutagen. 47, 362, 2006.
115. Clewell, H.J. 3rd, Andersen, M.E., and Barton, H.A., A consistent approach for the application of pharmacokinetic modeling in cancer and noncancer risk assessment, Environ. Health Perspect., 110, 85, 2002.
116. Conolly, R.B., The use of biologically based modeling in risk assessment, Toxicology, 181, 275, 2002.
117. Cornfield, J., Rai, K., and Van Ryzin, J., Procedures for assessing risk at low levels of exposure, Arch. Toxicol. Suppl. 3, 295, 1980.
118. Dorato, M.A. and Engelhardt, J.A., The no-observed-adverse-effect level in drug safety evaluations: use, issues, and definition(s), Regul. Toxicol. Pharmacol. 42, 265, 2005.
119. Eason, C. and O’Halloran, K., Biomarkers in toxicology versus ecological risk assessment, Toxicology, 181, 517, 2002.
120. Indans, I., The use and interpretation of in vitro data in regulatory toxicology: cosmetics, toiletries and household products, Toxicol. Lett., 127, 177, 2002.
121. Jensen, J. and Pedersen, M.B. Ecological risk assessment of contaminated soil, Rev. Environ. Contam. Toxicol., 186, 73, 2006.
122. Kowalski, L. et al., Overview of EPA Superfund human health research program, Int. J. Hyg. Environ. Health, 205, 143, 2002.
123. Lathers, C.M., Risk assessment in regulatory policy making for human and veterinary public health, J. Clin. Pharmacol., 42, 846, 2002.
124. Hansson, S.O. and Ruden, C., Evaluating the risk decision process, Toxicology, 218, 100, 2006.
125. Hayashi, Y., Designing in vitro assay systems for hazard characterization: basic strategies and related technical issues, Exp. Toxicol. Pathol., 57, 227, 2005.
126. Liebsch, M. and Spielmann, H., Currently available in vitro methods used in the regulatory toxicology, Toxicol. Lett., 127, 127, 2002.
127. Lorber, M., Indirect exposure assessment at the United States Environmental Protection Agency, Toxicol. Ind. Health, 17, 145, 2001.
128. Lu, F.C. and Sielken, R.L. Jr., Assessment of safety/risk of chemicals: inception and evolution of the ADI and dose-response modeling procedures, Toxicol. Lett., 59, 5, 1991.
129. Pirkle, J.L. et al., Using biological monitoring to assess human exposure to priority toxicants, Environ. Health Perspect., 103, 45, 1995.
130. Temple, R., Policy developments in regulatory approval, Stat. Med., 21, 2939, 2002.
131. Van Ryzin, J., Quantitative risk assessment, J. Occup. Med., 22, 321, 1980.
132. Weed, D.L., Weight of evidence: a review of concept and methods, Risk Anal., 25, 1545, 2005.
133. Bayne, K.A., Environmental enrichment of nonhuman primates, dogs and rabbits used in toxicology studies, Toxicol. Pathol., 31, 132, 2003.
134. Dirks, A.J. and Leeuwenburgh, C., Caloric restriction in humans: potential pitfalls and health concerns, Mech. Ageing Dev., 127, 1, 2006.
135. Heilbronn, L.K. and Ravussin, E., Calorie restriction and aging: review of the literature and implications for studies in humans, Am. J. Clin. Nutr., 78, 361, 2003.
136. Keenan, K.P., Laroque, P., and Dixit, R., Need for dietary control by caloric restriction in rodent toxicology and carcinogenicity studies, J. Toxicol. Environ. Health. B Crit, Rev., 1, 135, 1998.
137. U.S. Department of Agriculture, National Agricultural Library, Animal Welfare Information Center, http://www.nal.usda.gov.
138. Barrow, P.C., Reproductive toxicology studies and immunotherapeutics, Toxicology, 185, 205, 2003.
139. Bucher, J.R., The National Toxicology Program Rodent Bioassay: designs, interpretations, and scientific contributions, Ann. NY Acad. Sci., 982, 198, 2002.
140. Faulks, S.C, Turner, N., Else, P.L., and Hulbert, A.J., Calorie restriction in mice: effects on body composition, daily activity, metabolic rate, mitochondrial reactive oxygen species production, and membrane fatty acid composition, J. Gerontol. A Biol. Sci. Med. Sci., 61, 781, 2006.
141. Harper, J.M., et al., Stress resistance and aging: influence of genes and nutrition. Mech. Ageing Dev., 127, 687, 2006.
142. James, M.L., IACUC training: from new-member orientation to continuing education, Lab. Anim. (NY), 31, 26, 2002.
143. Leakey, J.E.A., Seng, J.E., and Allaben, W.T., Influence of body weight, diet, and stress on aging, survival and pathological endpoints in rodents: implications for toxicity testing and risk assessment, Reg. Res. Perspectives, 4, 1, 2004.
144. Merry, B.J., Oxidative stress and mitochondrial function with aging the effects of calorie restriction, Aging Cell, 3, 7, 2004.
145. Meyer, O., Testing and assessment strategies, including alternative and new approaches, Toxicol. Lett., 140, 21, 2003.
146. Pauluhn, J., Overview of testing methods used in inhalation toxicity: from facts to artifacts, Toxicol. Lett., 140, 183, 2003.
147. Pitts, M., A guide to the new ARENA/OLAW IACUC guidebook, Lab. Anim. (NY), 31, 40, 2002.
148. Rogers, J.V. and McDougal, J.N., Improved method for in vitro assessment of dermal toxicity for volatile organic chemicals, Toxicol. Lett., 135, 125, 2002.
149. Silverman, J., Animal breeding and research protocols: the missing link, Lab. Anim. (NY), 31, 19, 2002.
150. Smialowicz, R.J., The rat as a model in developmental immunotoxicology, Hum. Exp. Toxicol., 21, 513, 2002.
151. Steneck, N.H., Role of the institutional animal care and use committee in monitoring research, Ethics Behav., 7, 173, 1997.
152. Stephenson, W., Institutional animal care and use committees and the moderate position, Between Species, 7, 6, 1991.
153. Whitney, R.A., Animal care and use committees: history and current policies in the United States, Lab. Anim. Sci., 37, 18, 1987.
154. Clode, S.A., Assessment of in vivo assays for endocrine disruption, Best Pract. Res. Clin. Endocrinol. Metab., 20, 35, 2006.
155. Huxley, A., Testing is necessary on animals as well as in vitro, Nature, 439, 138, 2006.
156. Lamb, J.C. and Brown, S.M., Chemical testing strategies for predicting health hazards to children, Reprod. Toxicol., 14, 83, 2000.
157. Travis, K.Z., Pate, I., and Welsh, Z.K., The role of the benchmark dose in a regulatory context, Regul. Toxicol. Pharmacol., 43, 280, 2005.
158. Botham, P.A., Acute systemic toxicity: prospects for tiered testing strategies, Toxicol. in Vitro, 18, 227, 2004.
159. Brent, R.L., Utilization of animal studies to determine the effects and human risks of environmental toxicants (drugs, chemicals, and physical agents), Pediatrics, 113, 984, 2004.
160. Gelbke, H.P., Kayser, M., and Poole, A., OECD test strategies and methods for endocrine disruptors, Toxicology, 205, 17, 2004.
161. Krishna, G., Urda, G., and Theiss, J., Principles and practices of integrating genotoxicity evaluation into routine toxicology studies: a pharmaceutical industry perspective, Environ. Mol. Mutagen, 32, 115, 1998.
162. Meyer, O., Testing and assessment strategies, including alternative and new approaches, Toxicol. Lett., 140, 21, 2003.
163. Pauluhn, J., Overview of inhalation exposure techniques: strengths and weaknesses, Exp. Toxicol. Pathol., 57, 111, 2005.
164. Rispin, A., et al., Alternative methods for the median lethal dose (LD50) test: the up-and-down procedure for acute oral toxicity, ILAR J., 43, 233, 2002.
165. Rosenkranz, H.S. and Cunningham, A.R., Lack of predictivity of the rat lethality (LD50) test for ecological and human health effects, Altern. Lab. Anim., 33, 9, 2005.
166. Rosolen, S.G., Rigaudiere, F., Le Gargasson, J.F., and Brigell, M.G., Recommendations for a toxicological screening ERG procedure in laboratory animals, Doc. Ophthalmol., 110, 57, 2005.
167. Schlede, E. et al., Oral acute toxic class method: a successful alternative to the oral LD50 test, Regul. Toxicol. Pharmacol., 42, 15, 2005.
168. Stallard, N. and Whitehead, A., A statistical evaluation of the fixed dose procedure, Altern. Lab. Anim., 32, 2004.
169. The Revised Up-and-Down Procedure: A Test Method for Determining the Acute Oral Toxicology of Chemicals, 2001, NIH Publication 02-4501, http://iccvam.niehs.nih.gov/ docs/docs.htm#udp.
170. Walker, D.K., The use of pharmacokinetic and pharmacodynamic data in the assessment of drug safety in early drug development, Br. J. Clin. Pharmacol., 58, 601, 2004.
171. Allaben, W.T. et al., FDA points-to-consider documents: the need for dietary control for the reduction of experimental variability within animal assays and the use of dietary restriction to achieve dietary control, Toxicol. Pathol., 24, 776, 1996.
172. Barlow, S.M., Agricultural chemicals and endocrine-mediated chronic toxicity or carcinogenicity, Scand. J. Work Environ. Health, 31, 141, 2005.
173. Combes, R., Gaunt, I., and Balls, M., A scientific and animal welfare assessment of the OECD Health Effects Test Guidelines for the safety testing of chemicals under the European Union REACH system, Altern. Lab. Anim., 34, 77, 2006.
174. Cooper, R.L. et al., A tiered approach to life stages testing for agricultural chemical safety assessment, Crit. Rev. Toxicol., 36, 69, 2006.
175. Lai, M.W. et al., Annual report of the American Association of Poison Control Centers’ national poisoning and exposure database, Clin. Toxicol., 44, 803, 2006.
176. Lin, K.K., Progress report on the guidance for industry for statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals, J. Biopharm. Stat., 10, 481, 2000.
177. International Conference on Harmonisation, Guidance on the duration of chronic toxicity testing in animals (rodent and nonrodent toxicity testing), availability, U.S. Food and Drug Administration, Fed. Regist., 64, 34259, 1999.
178. Van Cauteren, H. et al., The industry view on long-term toxicology testing in drug development of human pharmaceuticals, Pharmacol. Toxicol., 86, 1, 2000.
179. Cunha, G.C. and van Ravenzwaay, B., Evaluation of mechanisms inducing thyroid toxicity and the ability of the enhanced OECD Test Guideline 407 to detect these changes, Arch. Toxicol., 79, 390, 2005.
180. Doe, J.E., Lewis, R.W., and Botham, P.A., Comments on a scientific and animal welfare assessment of the OECD Health Effects Test Guidelines for the safety testing of chemicals under the European Union REACH system, Altern. Lab. Anim., 34, 111, 2006.
181. Gelbke, H.P., Hofmann, A., Owens, J.W., and Freyberger A., The enhancement of the subacute repeat dose toxicity test OECD TG 407 for the detection of endocrine active chemicals:comparison with toxicity tests of longer duration, Arch. Toxicol., 2006 [Epub ahead of print].
182. Hard, G.C. and Khan, K.N., A contemporary overview of chronic progressive nephropathy in the laboratory rat, and its significance for human risk assessment, Toxicol. Pathol., 32, 171, 2004.
183. Hoffmann, S. and Hartung, T., Toward an evidence-based toxicology, Hum. Exp. Toxicol., 25, 497, 2006.
184. Hutchinson, T.H., Shillabeer, N., Winter, M.J., and Pickford, D.B., Acute and chronic effects of carrier solvents in aquatic organisms: a critical review, Aquat. Toxicol., 76, 69, 2006.
185. Kroes, R. et al., Threshold of toxicological concern for chemical substances present in the diet: a practical tool for assessing the need for toxicity testing, Food Chem. Toxicol., 38, 255, 2000.
186. McCarty, L.S. and Borgert, C.J., Review of the toxicity of chemical mixtures: theory, policy, and regulatory practice, Regul. Toxicol. Pharmacol., 45, 119, 2006.
187. Tetko, I.V. et al., Can we estimate the accuracy of ADME-Tox predictions? Drug Discov. Today, 11, 700, 2006.
188. Basketter, D.A. et al., Threshold for classification as a skin sensitizer in the local lymph node assay: a statistical evaluation, Food Chem. Toxicol., 37, 1, 1999.
189. Draize, J.H. and Kelley, E.A., The urinary excretion of boric acid preparations following oral administration and topical applications to intact and damaged skin of rabbits, Toxicology, 1, 267, 1959.
190. Draize, J. H., Woodward, G., and Calvery, H.O., Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes, J. Pharmacol. Exp. Ther., 82, 377, 1944.
191. Friedenwald, J.S. and Buschke, W., Some factors concerned in the mitotic and wound-healing activities of the corneal epithelium, Trans. Am. Ophthalmol. Soc., 42, 371, 1944.
192. ICCVAM, The murine local lymph node assay, NIH Publication 99-4494, Research Triangle Park, NC, 1999, http:/iccvam.niehs.nih.gov/methods/epiddocs/cwgfinal/cwgfinal.html.
193. Jester, J.V., Extent of corneal injury as a biomarker for hazard assessment and the development of alternative models to the Draize rabbit eye test, Cutan. Ocul. Toxicol., 25, 41, 2006.
194. Magnusson, B. and Kligman, A.M., The identification of contact allergens by animal assay:the guinea pig maximization test, J. Invest. Dermatol., 52, 268, 1969.
195. Martinez, V. et al., Evaluation of eye and skin irritation of arginine-derivative surfactants using different in vitro endpoints as alternatives to in vivo assays, Toxicol. Lett., 164, 259, 2006.
196. Secchi, A. and Deligianni, V., Ocular toxicology: the Draize eye test, Curr. Opin. Allergy Clin. Immunol., 6, 367, 2006.
197. Wilhelmus, K.R., The Draize eye test. Surv. Ophthalmol., 45, 493, 2001.
198. Abraham, M.H. et al., Draize rabbit eye test compatibility with eye irritation thresholds in humans: a quantitative structure-activity relationship analysis, Toxicol. Sci., 76, 384, 2003.
199. Auletta, C.S., Current in vivoassays for cutaneous toxicity: local and systemic toxicity testing, Basic Clin. Pharmacol. Toxicol., 95, 201, 2004.
200. Basketter D.A. et al., Evaluation of the skin sensitizing potency of chemicals by using the existing methods and considerations of relevance for elicitation, Cont. Derm., 52, 39, 2005.
201. Buehler, E.V., Occlusive patch method for skin sensitization in guinea pigs: the Buehler method, Food Chem. Toxicol., 32, 97, 1994.
202. Chatterjee, A., Babu, R.J., Ahaghotu, E. and Singh, M., The effect of occlusive and unocclusive exposure to xylene and benzene on skin irritation and molecular responses in hairless rats, Arch. Toxicol., 79, 294, 2005.
203. Frankild, S., Volund, A., Wahlberg, J.E., and Andersen, K.E., Comparison of the sensitivities of the Buehler test and the guinea pig maximization test for predictive testing of contact allergy, Acta Derm. Venereol., 80, 256, 2000.
204. Kimber, I. et al., Skin sensitization testing in potency and risk assessment, Toxicol. Sci., 59, 198, 2001.
205. Maurer, J.K., Parker, R.D., and Carr, G.J., Ocular irritation: microscopic changes occurring over time in the rat with surfactants of known irritancy, Toxicol. Pathol., 26, 217, 1998.
206. McDougal, J.N. and Boeniger, M.F., Methods for assessing risks of dermal exposures in the workplace, Crit. Rev. Toxicol., 32, 291, 2002.
207. OECD, Guideline 429: Murine Local Lymph Node Assay, http://www.oecd.org.
208. Prinsen, M.K., The Draize eye test and in vitro alternatives: a left-handed marriage? Toxicol. in Vitro, 20, 78, 2006.
209. Roberts, J.E., Screening for ocular phototoxicity, Int. J. Toxicol., 21, 491, 2002.
210. Robinson, M.K., Nusair, T.L., Fletcher, E.R., and Ritz, H.L., A review of the Buehler guinea pig skin sensitization test and its use in a risk assessment process for human skin sensitization, Toxicology, 61, 91, 1990.
211. Robinson, M.K. and Perkins, M.A., A strategy for skin irritation testing, Am. J. Contact Derm., 13, 21, 2002.
212. Svendsen, O., The minipig in toxicology, Exp. Toxicol. Pathol., 57, 335, 2006.
213. York, M. and Steiling, W., A critical review of the assessment of eye irritation potential using the Draize rabbit eye test, J. Appl. Toxicol., 18, 233, 1998.
214. Anonymous, International Conference on Harmonisation: guidelines on detection of toxicity to reproduction for medicinal products, Fed. Reg., 59, 48746, 1994.
215. Flick, B. and Klug, S., Whole embryo culture: an important tool in developmental toxicology today, Curr. Pharm. Des., 12, 1467, 2006.
216. Hurtt, M.E., Cappon, G.D., and Browning A., Proposal for a tiered approach to developmental toxicity testing for veterinary pharmaceutical products for food-producing animals. Food Chem. Toxicol., 41, 611, 2003.
217. Organization of Teratogen Information Services, http://www.otispregnancy.org/, last accessed November 20, 2006.
218. U.S. Environmental Protection Agency, Health Effects Test Guidelines, OPPTS 870.3700, Prenatal Developmental Toxicity Study, EPA 712, 207, 1998.
219. Bignami, G., Economical test methods for developmental neurobehavioral toxicity, Environ. Health Perspect., 104, 285, 1996.
220. Brachet, A. Recherches sur le determinism hereditaire de l’ouef des manniferes: development in vitro de jeunes vesicules blastodermique du lapin, Arch. Biol., 28, 447, 1913.
221. Buschmann, J., Critical aspects in reproductive and developmental toxicity testing of environmental chemicals, Reprod. Toxicol., 22, 157, 2006.
222. Cohen, S.M., Robinson, D., and MacDonald, J., Alternative models for carcinogenicity testing, Toxicol. Sci., 64, 14, 2001.
223. Detailed Review Document on Classification Systems for Reproductive Toxicity in OECD Member Countries, OECD Series on Testing and Assessment, Number 15, 1999.
224. Foote, R.H. and Carney, E.W., The rabbit as a model for reproductive and developmental toxicity studies, Reprod. Toxicol., 14, 477, 2000.
225. Hurtt, M.E., Cappon, G.D., and Browning A., Proposal for a tiered approach to developmental toxicity testing for veterinary pharmaceutical products for food-producing animals, Food Chem. Toxicol., 41, 611, 2003.
226. Jelinek, R., The contribution of new findings and ideas to the old principles of teratology, Reprod. Toxicol., 20, 295, 2005.
227. Riecke, K. and Stahlmann, R., Test systems to identify reproductive toxicants. Andrologia, 32, 209, 2000.
228. Seed, J., et al., Methods for assessing sperm motility, morphology, and counts in the rat, rabbit, and dog: a consensus report, Reprod. Toxicol., 10, 237, 1996.
229. Storgaard, L., Bonde, J.P., and Olsen, J., Male reproductive disorders in humans and prenatal indicators of estrogen exposure: a review of published epidemiological studies, Reprod. Toxicol., 21, 4, 2006.
230. Tam, P.P., Post-implantation mouse development: whole embryo culture and micro-manipulation, Int. J. Dev. Biol., 42, 895, 1998.
231. Walker, R., The significance of excursions above the ADI: duration in relation to pivotal studies, Regul. Toxicol. Pharmacol., 30, S114, 1999.
232. Webster, W.S., Brown-Woodman, P.D., and Ritchie, H.E., A review of the contribution of whole embryo culture to the determination of hazard and risk in teratogenicity testing, Int. J. Dev. Biol., 41, 329, 1997.
233. Ames, B.N., Identifying environmental chemicals causing mutations and cancer, Science, 204, 587, 1979.
234. Ames, B.N., Gold, L.S., and Willett, W.E., The causes and prevention of cancer, Proc. Natl. Acad. Sci. USA, 92, 5258, 1995.
235. European Economic Community, Genotoxicity: specific aspects of regulatory genotoxicity tests for pharmaceuticals. Legislative Basis Directive 75/318/EEC, Brussels, 1995.
236. International Agency for Research on Cancer, http://www.iarc.fr.
237. Tavtigian, S.V., Pierotti, M.A., and Borresen-Dale, A.L., International Agency for Research on Cancer Workshop on expression array analyses in breast cancer taxonomy, Breast Cancer Res., 8, 303, 2006 [Epub ahead of print].
238. Weisburger, J.H. and Williams, G.M., The decision-point approach for systematic carcinogen testing, Food Cosmet. Toxicol., 19, 561, 1981.
239. Williams, G.M. and Weisburger, J.H., Application of a cellular test battery in the decision point approach to carcinogen identification, Mutat. Res., 205, 79, 1988.
240. Benigni, R. and Giuliani, A., Putting the predictive toxicology challenge into perspective:reflections on the results, Bioinformatics, 19, 1194, 2003.
241. Bennett, L.M. and Davis, B.J., Identification of mammary carcinogens in rodent bioassays, Environ. Mol. Mutagen., 39, 150, 2002.
242. Bristol, D.W., Wachsman, J.T., and Greenwell, A., The NIEHS Predictive Toxicology Evaluation Project: chemcarcinogenicity bioassays, Environ. Health Perspect., 104, 1001, 1996.
243. Carr, C.J. and Kolbye, A.C. Jr., A critique of the use of the maximum tolerated dose in bioassays to assess cancer risks from chemicals, Reg. Toxicol. Pharmacol., 14, 78, 1991.
244. Chico-Galdo, V. et al., Acrylamide, an in vivo thyroid carcinogenic agent, induces DNA damage in rat thyroid cell lines and primary cultures, Mol. Cell. Endocrinol., 257, 6, 2006.
245. Cimino, M.C., Comparative overview of current international strategies and guidelines for genetic toxicology testing for regulatory purposes, Environ. Mol. Mutagen., 47, 362, 2006.
246. Cohen, S.M. and Ellwein, L.B., Cell proliferation in carcinogenesis, Science, 249, 1007, 1990.
247. Contrera, J. and DeGeorge, J., In vivo transgenic bioassays and assessment of the carcinogenic potential of pharmaceuticals, Environ. Health Perspect., 106, 71, 1998.
248. Doe, J.E. et al., A tiered approach to systemic toxicity testing for agricultural chemical safety assessment, Crit. Rev. Toxicol., 36, 37, 2006.
249. Duerksen-Hughes, P.J. et al., Induction as a genotoxic test for 25 chemicals undergoing in vivo carcinogenicity testing, Environ. Health Perspect., 107, 805, 1999.
250. Gregory, A.R., Species comparisons in evaluating carcinogenicity in humans, Reg. Toxicol. Pharmacol., 8, 160, 1988.
251. Helma, C. and Kramer, S., A survey of the predictive toxicology challenge 2000-2001, Bioinformatics, 19, 1179, 2003.
252. Ikeda, M. et al., Combined genotoxic effects of radiation and a tobacco-specific nitrosamine in the lungs of gpt-delta transgenic mice. Mut. Res., 2006 [Epub ahead of print].
253. Jacobson-Kram, D., Sistare, F.D., and Jacobs, A.C., Use of transgenic mice in carcinogenicity hazard assessment, Toxicol. Pathol., 32, 49, 2004.
254. Jones, S. and Kazlauskas, A., Growth-factor-dependent mitogenesis requires two distinct phases of signaling, Nat. Cell Biol., 3, 165, 2001.
255. Kane, A.B., Animal models of malignant mesothelioma, Inhal. Toxicol., 18, 1001, 2006.
256. Keenan, K.P., Laroque, P., and Dixit, R., Need for dietary control by caloric restriction in rodent toxicology and carcinogenicity studies, J. Toxicol. Environ. Health B Crit. Rev., 1, 135, 1998.
257. MacDonald, J. et al., The utility of genetically modified mouse assays for identifying human carcinogens: a basic understanding and path forward, Toxicol. Sci., 77, 188, 2004.
258. Mebust, M., Crawford-Brown, D., Hofmann, W., and Schollnberger, H., Testing extrapolation of a biologically based exposure-response model from in vitro to in vivo conditions. Regul. Toxicol. Pharmacol., 35, 72, 2002.
259. Moolgavkar, S.H. and Knudson, A.G., Mutation and cancer: a model for human carcinogenesis, J. Natl. Cancer Inst., 66, 1037, 1981.
260. Perera, E.P., Perspectives on the risk assessment of nongenotoxic carcinogens and tumor promotors, Environ. Health Perspect., 94, 231, 1991.
261. Rao, G.N. and Huff, J., Refinement of long-term toxicity and carcinogenicity studies, Fundam. Appl. Toxicol., 15, 33, 1990.
262. Rao, P.M. et al., Dietary and metabolic manipulations of the carcinogenic process: role of nucleotide pool imbalances in carcinogenesis, Toxicol. Pathol., 15, 190, 1987.
263. Roe, F.J., Refinement of long term toxicity and carcinogenesis studies, Fundam. Appl. Toxicol., 16, 616, 1991.
264. Slamenova, D. Contemporary trends in in vivo and in vitro testing of chemical carcinogens, Neoplasma, 48, 425, 2001.
265. Tharappel, J.C. et al., Regulation of cell proliferation, apoptosis, and transcription factor activities during the promotion of liver carcinogenesis by polychlorinated biphenyls, Toxicol. Appl. Pharmacol., 179, 172, 2002.
266. Waddell, W.J., Fukushima, S., and Williams, G.M., Concordance of thresholds for carcinogenicity of N-nitrosodiethylamine, Arch. Toxicol., 80, 305, 2006.
267. Barile, F.A., Introduction to In Vitro Cytotoxicology: Mechanisms and Methods, CRC Press, Boca Raton, FL, 1994.
268. Eagle, H., Media for animal cell culture, Tissue Cult. Assn. Man., 3, 517, 1977.
269. Freshney, R.I., Culture of Animal Cells: A Manual of Basic Technique, 4th ed., Wiley-Liss, New York, 2000.
270. McGarrity, G.J., Serum quality control, Tissue Cult. Assn. Man., 1, 167, 1975.
271. Robertson, A.L., Envelop technique for selective isolation of cells from multilayer organ cultures for metabolic studies, Tissue Cult. Assn. Man., 1, 139, 1975.
272. Weiss, L., Cell contact phenomena, in Advances in Tissue Culture, Waymouth, C., Ed., Williams and Wilkins, Baltimore, 1970, p. 48.
273. Abir, R., Nitke, S., Ben-Haroush, A., and Fisch, B., In vitro maturation of human primordial ovarian follicles: clinical significance, progress in mammals, and methods for growth evaluation, Histol. Histopathol., 21, 887, 2006.
274. Aschner, M., Fitsanakis, V.A., dos Santos, A.P., Olivi, L., and Bressler, J.P., Blood-brain barrier and cell-cell interactions: methods for establishing in vitro models of the blood-brain barrier and transport measurements, Methods Mol. Biol., 341, 1, 2006.
275. Rippon, H.J. and Bishop, A.E., Embryonic stem cells, Cell Prolif., 37, 23, 2004.
276. Seth, G., Hossler, P., Yee, J.C., and Hu, W.S., Engineering cells for cell culture bioprocessing:physiological fundamentals, Adv. Biochem. Eng. Biotechnol., 101, 119, 2006.
277. Turksen, K. and Troy, T.C., Human embryonic stem cells: isolation, maintenance, and differentiation, Methods Mol. Biol., 331, 1, 2006.
278. American Type Culture Collection (ATCC), Manassas, VA, http://www.atcc.org.
279. Andrei, G., Three-dimensional culture models for human viral diseases and antiviral drug development, Antiviral Res., 71, 96, 2006.
280. El-Ali, J., Sorger, P.K., and Jensen, K.F., Cells on chips, Nature, 442, 403, 2006.
281. European Collection of Cell Cultures (ECACC), Porton Down, Wiltshire, U.K. http://www.ecacc.org.uk.
282. Hay, R.J., Human cells and cell cultures: availability, authentication and future prospects, Hum. Cell, 9, 143, 1996.
283. National Disease Research Interchange (NDRI), Philadelphia, http://www.ndriresource.org.
284. National Institutes of Health, Human Embryonic Stem Cell Registry, Bethesda, MD, http://stemcells.nih.gov/research/registry.
285. Seth, G., Hossler, P., Yee, J.C., and Hu, W.S., Engineering cells for cell culture bioprocessing:physiological fundamentals, Adv. Biochem. Eng. Biotechnol., 101, 119, 2006.
286. Williams, D.J. and Sebastine, I.M., Tissue engineering and regenerative medicine: manufacturing challenges, IEE Proc. Nanobiotechnol., 152, 207, 2005.
287. Wlaschin, K.F. and Hu, W.S., Feedbatch culture and dynamic nutrient feeding, Adv. Biochem. Eng. Biotechnol., 101, 43, 2006.
288. Alonso, L. and Fuchs, E., Stem cells of the skin epithelium, Proc. Natl. Acad. Sci. USA, 100, 11830, 2003.
289. Bradley, A., Evans, M., Kaufman, M., and Robertson, E., Formation of germ-line chimaeras from embryo-derived teratocarcinoma cell lines, Nature, 309, 255, 1984.
290. Butler, M., Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals, Appl. Microbiol. Biotechnol., 68, 283, 2005.
291. Evans, M., and Kaufman, M., Establishment in culture of pluripotential cells from mouse embryos, Nature, 92, 154, 1981.
292. Even, M.S., Sandusky, C.B., and Barnard, N.D., Serum-free hybridoma culture: ethical, scientific and safety considerations, Trends Biotechnol. 24, 105, 2006.
293. Findikli, N., Candan, N.Z., and Kahraman, S., Human embryonic stem cell culture: current limitations and novel strategies, Reprod. Biomed. Online, 13, 581, 2006.
294. Garner, J.P., Tissue engineering in surgery, Surgeon, 2, 70, 2004.
295. Kim, J.B., Three-dimensional tissue culture models in cancer biology, Semin. Cancer Biol., 15, 365, 2005.
296. Kuwahara, M. et al. In vitro organogenesis of gut-like structures from mouse embryonic stem cells, Neurogastroenterol. Motil., 16, 14, 2004.
297. Mackenzie, I.C., Stem cell properties and epithelial malignancies, Eur J. Cancer, 42, 1204, 2006.
298. Rosolowsky, M., McKee, R., Nichols, W., and Garfinkle, B., Chromosomal characterization of MRC-5 cell banks utilizing G-banding technique, Dev. Biol. Stand., 93, 109, 1998.
299. Thorgeirsson, S.S. and Grisham, J.W., Overview of recent experimental studies on liver stem cells, Semin. Liver Dis., 23, 303, 2003.
300. Turksen, K. and Troy, T.C., Human embryonic stem cells: isolation, maintenance, and differentiation, Methods Mol. Biol., 331, 1, 2006.
301. Verlinsky, Y., et al., Repository of human embryonic stem cell lines and development of individual specific lines using stembrid technology, Reprod. Biomed. Online, 13, 547, 2006.
302. Barile, F.A., Continuous cell lines as a model for drug toxicity assessment, in In Vitro Methods in Pharmaceutical Research, Castell, J.V. and Gómez-Lechón, M.J., Eds., Academic Press, London, 1997.
303. Ekwall, B., Basal cytotoxicity data (BC data) in human risk assessment, in Proceedings of Workshop on Risk Assessment and Risk Management of Toxic Chemicals, National Institute for Environmental Studies, Ibaraki, Japan, 1992, p. 137.
304. Ekwall, B., The basal cytotoxicity concept, in Alternative Methods in Toxicology and the Life Sciences, Goldberg, A. and van Zupten, L.F.M., Eds., Mary Ann Liebert, New York, 1995, pp. 11, 721.
305. Ekwall, B. and Barile, F.A., Standardization and validation, in Introduction to In Vitro Cytotoxicology:Mechanisms and Methods, Barile, F.A., Ed., CRC Press, Boca Raton, FL, 1994, chap. 11.
306. Gautheron, P., Dukic, M., Alix, D., and Sina, J.F., Bovine corneal opacity and permeability test: an in vitro assay of ocular irritancy, Fundam. Appl. Toxicol., 18, 442, 1992.
307. Atkinson, K.A., Fentem, J.H., Clothier, R.H., and Balls, M., Alternatives to ocular irritation testing in animals, Lens Eye Toxic. Res., 9, 247, 1992.
308. Aufderheide, M., Knebel, J.W., and Ritter D., Novel approaches for studying pulmonary toxicity in vitro, Toxicol. Lett., 140, 205, 2003.
309. Barile, F.A. and Cardona, M., Acute cytotoxicity testing with cultured human lung and dermal cells, In Vitro Cell Develop. Biol. 34, 631, 1998.
310. Barile, F.A., Arjun, S., and Hopkinson, D., In vitro cytotoxicity testing: biological and statistical significance, Toxicol. in Vitro, 7, 111, 1993.
311. Basketter, D.A. et al., The classification of skin irritants by human patch test, Food Chem. Toxicol., 35, 845, 1997.
312. Bishop, A.E. and Rippon, H.J., Stem cells: potential for repairing damaged lungs and growing human lungs for transplant, Expert Opin. Biol. Ther., 6, 751, 2006.
313. Borenfreund, E. and Puerner, J.A., Cytotoxicity of metals, metal-metal and metal-chelator combinations assayed in vitro, Toxicology, 39, 121, 1986.
314. Braun, A. et al., Cell cultures as tools in biopharmacy, Eur. J. Pharm. Sci., 11, S51, 2000.
315. Bruner, L.H., Carr, G.J., Curren, R.D., and Chamberlain, M., Validation of alternative methods for toxicity testing, Environ. Health Perspect., 106, 477, 1998.
316. Burton, A.B., York, M., and Lawrence, R.S., The in vitro assessment of severe eye irritants, Food Cosmet. Toxicol., 19, 471, 1981.
317. Cockshott, A. et al., The local lymph node assay in practice: a current regulatory perspective, Hum. Exp. Toxicol., 25, 387, 2006.
318. Dearman, R.J., Basketter, D.A., and Kimber, I., Local lymph node assay: use in hazard and risk assessment, J. Appl. Toxicol., 19, 299, 1999.
319. Dolbeare, F. and Vanderlaan, M., Techniques for measuring cell proliferation, in In Vitro Toxicity Indicators, Methods in Enzymology, Tyson, C.A. and Frazier, J.M., Eds., Academic Press, San Diego, 1994, pp. 1B, 178.
320. Elaut, G. et al., Molecular mechanisms underlying the dedifferentiation process of isolated hepatocytes and their cultures, Curr. Drug Metab., 7, 629, 2006.
321. Fentem, J.H. and Botham, P.A., ECVAM’s activities in validating alternative tests for skin corrosion and irritation, Altern. Lab. Anim., 30, 61, 2002.
322. Forbes, B. and Ehrhardt, C., Human respiratory epithelial cell culture for drug delivery applications, Eur. J. Pharm. Biopharm., 60, 193, 2005.
323. Freed, L.E. and Vunjak-Novakovic, G., Space flight bioreactor studies of cells and tissues, Adv. Space Biol. Med., 8, 177, 2002.
324. Ginis, I. et al., Differences between human and mouse embryonic stem cells, Develop. Biol., 269, 360, 2004.
325. Gomez-Lechon, M.J., Donato, M.T., Castell, J.V., and Jover R., Human hepatocytes in primary culture: the choice to investigate drug metabolism in man, Curr. Drug Metab., 5, 443, 2004.
326. Guha, C., Lee, S.W., Chowdhury, N.R., and Chowdhury, J.R., Cell culture models and animal models of viral hepatitis, Part II: hepatitis C, Lab. Anim., 34, 39, 2005.
327. Hoffman, J. et al., Epidermal Skin Test 1000 (EST-1000): a new reconstructed epidermis for in vitro skin corrosivity testing, Toxicol. in Vitro, 19, 925, 2005.
328. Huggins, J., Alternatives to animal testing: research, trends, validation, regulatory acceptance, ALTEX, 20, 3, 2003.
329. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), Report of International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity, NIH Publication 01-4499. National Institute of Environmental Health Sciences, Research Triangle Park, NC, 2001. http://iccvam.niehs.nih.gov/docs/guidelines/ subguide.htm.
330. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), Guidance Document on Using in Vitro Data to Estimate in Vivo Starting Doses for Acute Toxicity, NIH Publication 01-4500. National Institute of Environmental Health Sciences, Research Triangle Park, NC, 2001. http://iccvam.niehs.nih.gov/docs/guide lines/subguide.htm.
331. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), Biennial Progress Report of National Toxicology Program, NIH Publication 04-4509, National Institute of Environmental Health Sciences, Research Triangle Park, NC, 2003. http://iccvam.niehs.nih.gov/about/annrpt/bienrpt044509.pdf.
332. Jones, B. and Stacey, G., Safety considerations for in vitro toxicology testing, Cell Biol. Toxicol., 17, 247, 2001.
333. Jones, P.A. et al., Comparative evaluation of five in vitro tests for assessing the eye irritation potential of hair care products, Altern. Lab. Anim., 29, 669, 2001.
334. Kimber, I. et al., The local lymph node assay and skin sensitization: a cut-down screen to reduce animal requirements? Contact Derm., 54, 181, 2006.
335. Louekari, K., Sihvonen, K., Kuittinen, M., and Somnes, V., In vitro tests within the REACH information strategies. Altern. Lab. Anim., 34, 377, 2006.
336. Mosmann, T., Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assays, J. Immunol. Meth., 65, 55, 1983.
337. Robinson, M.K. and Perkins, M.A., A strategy for skin irritation testing, Am. J. Contact Derm., 13, 21, 2002.
338. Robinson, M.K. et al., Non-animal testing strategies for assessment of the skin corrosion and skin irritation potential of ingredients and finished products, Food Chem. Toxicol., 40, 573, 2002.
339. Stobbe, J.L., Drake, K.D., and Maier, K.J., Comparison of in vivo (Draize method) and in vitro (Corrositex assay) dermal corrosion values for selected industrial chemicals, Int. J. Toxicol., 22, 99, 2003.
340. Ubels, J.L., Ditlev, J.A., Clousing, D.P., and Casterton, P.L., Corneal permeability in a redesigned corneal holder for the bovine cornea opacity and permeability assay, Toxicol. in Vitro, 18, 853, 2004.
341. Ubels, J.L., Pruis, R.M., Sybesma, J.T., and Casterton, P.L., Corneal opacity, hydration and endothelial morphology in the bovine cornea opacity and permeability assay using reduced treatment times, Toxicol. in Vitro, 14, 379, 2000.
342. Vermeir, M. et al., Cell-based models to study hepatic drug metabolism and enzyme induction in humans, Expert Opin. Drug Metab. Toxicol., 1, 75, 2005.
343. During, A. and Harrison, E.H., Intestinal absorption and metabolism of carotenoids: insights from cell culture, Arch. Biochem. Biophys., 430, 77, 2004.
344. Flint, O.P. and Orton, T.C., An in vitro assay for teratogens with cultures of rat embryo midbrain and limb bud cells, Toxicol. Appl. Pharmacol., 76, 383, 1984.
345. U.S. Food and Drug Administration, Guidance for Industry-Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro, Rockville, MD, 1997.
346. Andersen, M.E., Toxicokinetic modeling and its applications in chemical risk assessment, Toxicol. Lett., 138, 9, 2003.
347. Bakand, S., Winder, C., Khalil, C., and Hayes, A., Toxicity assessment of industrial chemicals and airborne contaminants: transition from in vivoto in vitro test methods: a review, Inhal. Toxicol., 17, 775, 2005.
348. Blaauboer, B.J., Biokinetic and toxicodynamic modelling and its role in toxicological research and risk assessment, Altern. Lab. Anim., 31, 277, 2003.
349. Ding, S., Yao, D., Burchell, B., Wolf, C.R., and Friedberg, T., High levels of recombinant CYP3A4 expression in Chinese hamster ovary cells are modulated by co-expression of human reductase and hemin supplementation, Arch. Biochem. Biophys., 348, 403, 1997.
350. Ekins, S. et al., Progress in predicting human ADME parameters in silico, J. Pharmacol. Toxicol. Meth., 44, 251, 2000.
351. Gonzales, F.J. and Korzekwa, K.R., Cytochrome P450 expression systems, Ann. Rev. Pharmacol. Toxicol., 35, 369, 1995.
352. Groneberg, D.A., Grosse-Siestrup, C., and Fischer, A., In vitro models to study hepatotoxicity, Toxicol. Pathol., 30, 394, 2002.
353. Guillouzo, A., Liver cells models in in vitro toxicology, Environ. Health Perspect., 106, 511, 1998.
354. Hayashi, Y., Designing in vitro assay systems for hazard characterization: basic strategies and related technical issues, Exp. Toxicol. Pathol., 57, 227, 2005.
355. Kedderis, G.L. and Lipscomb, J.C., Application of in vitro biotransformation data and pharmacokinetic modeling to risk assessment, Toxicol. Ind. Health, 17, 315, 2001.
356. Lin, J.H., Tissue distribution and pharmacodynamics: a complicated relationship, Curr. Drug Metab., 7, 39, 2006.
357. McCarley, K.D. and Bunge, A.L., Pharmacokinetic models of dermal absorption, J. Pharm. Sci., 90, 1699, 2001.
358. Zucco, F., De Angelis, I., Testai, E., and Stammati, A., Toxicology investigations with cell culture systems: 20 years after, Toxicol. in Vitro, 18, 153, 2004.
359. Ames, B.N., Gurney, E.G., Miller, J.A., and Bartsch, H., Carcinogens as frameshift mutagens:metabolites and derivatives of 2-acetylaminofluorene and other aromatic amine carcinogens, Proc. Natl. Acad. Sci. USA, 69, 3128, 1972.
360. Ames, B.N., Sims, P., and Grover, P.L., Epoxides of carcinogenic polycyclic hydrocarbons are frameshift mutagens, Science, 176, 47, 1972.
361. Ames, B.N., Identifying environmental chemicals causing mutations and cancer, Science, 204, 587, 1979.
362. Ames, B.N., Gold, L.S., and Willett, W.E., The causes and prevention of cancer, Proc. Natl. Acad. Sci. USA, 92, 5258, 1995.
363. Cohen, S.M. and Ellwein, L.B., Cell proliferation in carcinogenesis, Science, 249, 1007l, 1990.
364. Weinstein, I.B., Cancer prevention: recent progress, and future opportunities, Cancer Res., 51, 5080s, 1991.
365. Aardema, M.J. et al., SFTG international collaborative study on in vitro micronucleus test III. Using CHO cells, Mutat. Res., 607, 61, 2006.
366. Bolt, H.M., Foth, H., Hengstler, J.G., and Degen, G.H., Carcinogenicity categorization of chemicals: new aspects to be considered in a European perspective, Toxicol. Lett., 151, 29, 2004.
367. Brusick, D., Evolution of testing strategies for genetic toxicity, Mutat. Res., 205, 69, 1988.
368. Carere, A., Stammati, A., and Zucco, F., In vitro toxicology methods: impact on regulation from technical and scientific advancements, Toxicol Lett., 127, 153, 2002.
369. Clare, M.G. et al., SFTG international collaborative study on in vitro micronucleus test II. Using human lymphocytes, Mutat. Res., 607, 37, 2006.
370. Decordier, I. and Kirsch-Volders, M., The in vitro micronucleus test: from past to future, Mutat. Res., 607, 2, 2006.
371. Farmer, P.B., Committee on Mutagenicity (COM) of Chemicals in Food, Consumer Products and the Environment ILSI/HESI research programme on alternative cancer models:results of Syrian hamster embryo cell transformation assay. Toxicol. Pathol., 30, 536, 2002.
372. Hartley-Asp, B., Wilkinson, R., Venitt, S., and Harrap, K.R., Studies on the mechanism of action of LS 1727, a nitrosocarbamate of 19-nortestosterone. Acta Pharmacol. Toxicol., 48, 129, 1981.
373. Kirkland, D.J. et al., Testing strategies in mutagenicity and genetic toxicology: an appraisal of the guidelines of the European Scientific Committee for Cosmetics and Non-Food Products for the evaluation of hair dyes, Mutat. Res., 588, 88, 2005.
374. Kowalski, L.A., In vitro carcinogenicity testing: present and future perspectives in pharmaceutical development, Curr. Opin. Drug Discov. Devel., 4, 29, 2001.
375. Müller, L. et al., ICH-harmonized guidances on genotoxicity testing of pharmaceuticals:evolution, reasoning and impact, Mutat. Res., 436, 195, 1999.
376. MacGregor, J.T., Casciano, D., and Muller, L., Strategies and testing methods for identifying mutagenic risks, Mutat. Res., 455, 3, 2000.
377. Nesnow, S., Complex mixtures of chemical carcinogens, in Molecular Carcinogenesis and the Molecular Biology of Human Cancer, Warshawsky, D. and Landolph, J., Eds., CRC Press, Boca Raton, FL, 2006, chap. 14.
378. Oliver, J. et al., SFTG international collaborative study on in vitro micronucleus test V. Using L5178Y cells, Mutat. Res., 607, 125, 2006.
379. Parry, J.M. and Parry, E.M., The use of the in vitro micronucleus assay to detect and assess the aneugenic activity of chemicals, Mutat. Res., 607, 5, 2006.
380. Preston, R.J., Genetic toxicology, in Introduction to Biochemical Toxicology, 3rd ed., Hodgson, R. and Smart, R., Eds., John Wiley and Sons, New York, 2001, chap. 16.
381. Rothfuss, A., Steger-Hartmann, T., Heinrich, N., and Wichard, J., Computational prediction of the chromosome-damaging potential of chemicals, Chem. Res. Toxicol., 19, 1313, 2006.
382. Schramke, H. et al., The mouse lymphoma thymidine kinase assay for the assessment and comparison of the mutagenic activity of cigarette mainstream smoke particulate phase, Toxicology, 227, 193, 2006.
383. Wexler, P., The U.S. National Library of Medicine’s Toxicology and Environmental Health Information Program, Toxicology, 198, 161, 2004.
384. Williams, G.M., Detection of chemical carcinogens by unscheduled DNA synthesis in rat liver primary cell cultures, Cancer Res., 37, 1845, 1977.
385. Bremer, S. and Hartung T., The use of embryonic stem cells for regulatory developmental toxicity testing in vitro: the current status of test development, Curr. Pharm. Des., 10, 2733, 2004.
386. Brown, N.A., Selection of test chemicals for the ECVAM international validation study on in vitro embryotoxicity tests, Altern. Lab. Animals, 30, 177, 2002.
387. Flint, O.P., In vitro tests for teratogens: desirable endpoints, test batteries and current status of the micromass teratogen test, Reprod. Toxicol., 7, 103, 1993.
388. Genbacev, O., White, T.E., Gavin, C.E., and Miller, R.K., Human trophoblast cultures: models for implantation and peri-implantation toxicology, Reprod. Toxicol., 7, 75, 1993.
389. Genschow, E. et al., The ECVAM international validation study on in vitro embryotoxicity tests: results of the definitive phase and evaluation of prediction models, Altern. Lab. Animal, 30, 151, 2002.
390. Genschow, E. et al., Validation of the embryonic stem cell test in the international ECVAM validation study on three in vitro embryotoxicity tests, Altern. Lab. Animals I, 32, 209, 2004.
391. Kirkland, D.J. et al., Testing strategies in mutagenicity and genetic toxicology: an appraisal of the guidelines of the European Scientific Committee for Cosmetics and Non-Food Products for the evaluation of hair dyes, Mutat. Res., 588, 88, 2005.
392. Palmer, A.K., Introduction to (pre)screening methods, Reprod. Toxicol., 7, 95, 1993.
393. Barile. F.A., Ripley-Rouzier, C., Siddiqi, Z.E., and Bienkowski R.S., Effects of prostaglandin E1 on collagen production and degradation in human fetal lung fibroblasts, Arch. Biochem. Biophys., 265, 441, 1988.
394. Barile, F.A., Siddiqi, Z.E., Ripley-Rouzier, C., and Bienkowski, R.S., Effects of puromycin and hydroxynorvaline on net production and intracellular degradation of collagen in human fetal lung fibroblasts, Arch. Biochem. Biophys., 270, 294, 1989.
395. Barile, F.A., Arjun, S., and Hopkinson D., In vitro cytotoxicity testing: biological and statistical significance, Toxicol. in Vitro, 7, 111, 1993.
396. Bechter, R., The validation and use of in vitro teratogenicity tests, Arch. Toxicol. Suppl., 17, 170, 1995.
397. Brachet, A., Recherches sur le determinism hereditaire de l’oeuf des mammiferes: development in vitro de jeunes vesicules blastodermique du lapin, Arch. Biol., 28, 447, 1913.
398. Brown, N.A., Teratogenicity testing in vitro: status of validation studies, Arch. Toxicol., 11, 105, 1987.
399. Buesen, R. et al., Trends in improving the embryonic stem cell test (EST): an overview, ALTEX, 21, 15, 2004.
400. Edwards, R.G., Stem cells today: Origin and potential of embryo stem cells, Reprod. Biomed. Online, 8, 275, 2004.
401. Evans, M. and Kaufman, M., Establishment in culture of pluripotential cells from mouse embryos, Nature, 92, 154, 1981.
402. Fein, A. et al., Peri-implantation mouse embryos: an in vitro assay for assessing serumassociated embryotoxicity in women with reproductive disorders, Reprod. Toxicol., 12, 155, 1998.
403. Flick, B. and Klug, S., Whole embryo culture: an important tool in developmental toxicology today, Curr. Pharm. Des., 12, 1467, 2006.
404. Flint, O. and Orton, T.C., An in vitro assay for teratogens with cultures of rat embryo midbrain and limb bud cells, Toxicol. Appl. Pharmacol., 76, 383, 1984.
405. Newall, D.R. and Beedles, K., The stem cell test: a novel in vitro assay for teratogenic potential, Toxicol. in Vitro, 8, 697, 1994.
406. Pellizzer, C., Bremer, S., and Hartung, T., Developmental toxicity testing from animal toward embryonic stem cells, ALTEX, 22, 47, 2005.
407. Piersma, A.H., Validation of alternative methods for developmental toxicity testing, Toxicol. Lett., 149, 147, 2004.
408. Riecke, K. and Stahlmann, R., Test systems to identify reproductive toxicants, Andrologia, 32, 209, 2000.
409. Rohwedel, J., Guan, K., Hegert, C., and Wobus, A.M., Embryonic stem cells as an in vitro model for mutagenicity, cytotoxicity and embryotoxicity studies: present state and future prospects, Toxicol. in Vitro, 15, 741, 2001.
410. Spielmann, H. and Liebsch, M., Validation successes: chemicals, Altern. Lab. Animals, 30, 33, 2002.
411. Tam, P.P., Post-implantation mouse development: whole embryo culture and micro-manipulation, Int. J. Develop. Biol., 42, 895, 1998.
412. Webster, W.S., Brown-Woodman, P.D., and Ritchie, H.E., A review of the contribution of whole embryo culture to the determination of hazard and risk in teratogenicity testing, Int. J. Dev. Biol., 41, 329, 1997.
413. Chan, V.S. and Theilade, M.D., The use of toxicogenomic data in risk assessment: a regulatory perspective, Clin. Toxicol., 43, 121, 2005.
414. Chen, T., DNA microarrays: an armory for combating infectious diseases in the new century, Infect. Disord. Drug Targets, 6, 263, 2006.
415. Cummins, J.M. and Velculescu, V.E., Implications of micro-RNA profiling for cancer diagnosis, Oncogene, 25, 6220, 2006.
416. Khaitovich, P., Enard, W., Lachmann, M., and Paabo, S., Evolution of primate gene expression, Nat. Rev. Genet., 7, 693, 2006.
417. Koczan, D. and Thiesen, H.J., Survey of microarray technologies suitable to elucidate transcriptional networks as exemplified by studying KRAB zinc finger gene families, Proteomics, 6, 4704, 2006.
418. Leighton, J.K. et al., Workgroup report: review of genomics data based on experience with mock submissions: view of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee, Environ. Health Perspect., 114, 573, 2006.
419. Lettieri, T., Recent applications of DNA microarray technology to toxicology and ecotoxicology, Environ. Health Perspect., 114, 4, 2006.
420. Modlich, O., Prisack, H.B., and Bojar, H., Breast cancer expression profiling: the impact of microarray testing on clinical decision making, Exp. Opin. Pharmacother., 7, 2069, 2006.
421. Atterwill, C.K. and Wing, M.G., In vitro preclinical lead optimisation technologies (PLOTs) in pharmaceutical development, Toxicol. Lett., 127, 143, 2002.
422. Breitling, R., Biological microarray interpretation: the rules of engagement, Biochim. Biophys. Acta, 1759, 319, 2006.
423. Bugelski, P.J., Gene expression profiling for pharmaceutical toxicology screening, Curr. Opin. Drug Discov. Devel., 5, 79, 2002.
424. Coppola, G. and Geschwind, D.H., Microarrays and the microscope: balancing throughput with resolution, J. Physiol., 575, 353, 2006.
425. Ekins, S., Systems: ADME/tox resources and network approaches, J. Pharmacol. Toxicol. Methods, 53, 38, 2006.
426. Garaizar, J., Rementeria, A., and Porwollik, S., DNA microarray technology: a new tool for the epidemiological typing of bacterial pathogens? FEMS Immunol. Med. Microbiol., 47, 178, 2006.
427. Gibson, N.J., Application of oligonucleotide arrays to high-content genetic analysis, Exp. Rev. Mol. Diagn., 6, 451, 2006.
428. Guillouzo, A., Applications of biotechnology to pharmacology and toxicology, Cell Mol. Biol., 47, 1301, 2001.
429. Irwin, R.D. et al., Application of toxicogenomics to toxicology: basic concepts in the analysis of microarray data, Toxicol. Pathol., 32, 72, 2004.
430. Jafari, P. and Azuaje, F., An assessment of recently published gene expression data analyses:reporting experimental design and statistical factors, BMC Med. Inform. Decis. Mak., 6, 27, 2006.
431. Jubb, A.M. et al., Quantitative in situ hybridization of tissue microarrays, Methods Mol. Biol., 326, 255, 2006.
432. Li, N., Tourovskaia, A., and Folch, A., Biology on a chip: microfabrication for studying the behavior of cultured cells, Crit. Rev. Biomed. Eng., 31, 423, 2003.
433. Low, Y.L., Wedren, S., and Liu, J., High-throughput genomic technology in research and clinical management of breast cancer: evolving landscape of genetic epidemiological studies, Breast Cancer Res., 8, 209, 2006.
434. Mans, J.J., Lamont, R.J., and Handfield, M., Microarray analysis of human epithelial cell responses to bacterial interaction, Infect. Disord. Drug Targets, 6, 299, 2006.
435. Maurer, H.H., Screening procedures for simultaneous detection of several drug classes used for high throughput toxicological analyses and doping control: a review, Comb. Chem. High Throughput Screen., 3, 467, 2000.
436. Meador, V., Jordan, W., and Zimmermann, J., Increasing throughput in lead optimization in in vivotoxicity screens, Curr. Opin. Drug Discov. Devel., 5, 72, 2002.
437. Merrick, B.A. and Bruno, M.E., Genomic and proteomic profiling for biomarkers and signature profiles of toxicity, Curr. Opin. Mol Ther., 6, 600, 2004.
438. Nielsen, T.O., Microarray analysis of sarcomas, Adv. Anat. Pathol. 13, 166, 2006.
439. Petrik, J. Diagnostic applications of microarrays, Transfus. Med., 16, 233, 2006.
440. Seo, D., Ginsburg, G.S., and Goldschmidt-Clermont, P.J., Gene expression analysis of cardiovascular diseases: novel insights into biology and clinical applications, J. Am. Coll. Cardiol., 48, 227, 2006.
441. Shioda, T., Application of DNA microarray to toxicological research, J. Environ. Pathol. Toxicol. Oncol., 23, 13, 2004.
442. Shockcor, J.P. and Holmes, E., Metabonomic applications in toxicity screening and disease diagnosis, Curr. Top. Med. Chem., 2, 35, 2002.
443. Sievertzon, M., Nilsson, P., and Lundeberg, J., Improving reliability and performance of DNA microarrays, Exp. Rev. Mol. Diagn., 6, 481, 2006.
444. Sobek, J. et al., Microarray technology as a universal tool for high-throughput analysis of biological systems, Comb. Chem. High Throughput Screen., 9, 365, 2006.
445. Walmsley, R.M., Genotoxicity screening: the slow march to the future, Exp. Opin. Drug Metab. Toxicol., 1, 261, 2005.
446. Barile, F.A., Introduction to In Vitro Cytotoxicology: Mechanisms and Methods, CRC Press, Boca Raton, FL, 1994.
447. Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man, 7th ed., Biomedical Publications, Foster City, CA, 2004.
448. Chow, S.C. and Shao, J., Statistics in Drug Research: Methodologies and Recent Developments, CRC Press, Boca Raton, FL, 2002.
449. Daniel, W.W., Biostatistics: A Foundation for Analysis in the Health Sciences, 8th ed., John Wiley and Sons, New York, 2006.
450. Gad, S.C., Statistics and Experimental Design for Toxicologists and Pharmacologists, 4th ed., Taylor and Francis, Boca Raton, FL, 2005.
451. Lewis, R.J., Jr., Hazardous Chemicals Desk Reference, John Wiley and Sons, New York, 2002.
452. Skillings, J.H. and Weber, D., A First Course in the Design of Experiments: A Linear Models Approach, CRC Press, Boca Raton, FL, 1999.
453. The Merck Index, 14th ed., O’Neil, M.J. et al., Eds., Merck Research Laboratories, Whitehouse Station, NJ, 2006.
454. Bernauer, U., Oberemm, A., Madle, S., and Gundert-Remy, U., The use of in vitro data in risk assessment, Basic Clin. Pharmacol. Toxicol., 96, 176, 2005.
455. Elliott, M.R., Joffe, M.M., and Chen, Z., A potential outcomes approach to developmental toxicity analyses, Biometrics, 62, 352, 2006.
456. Hayashi, Y., Designing in vitro assay systems for hazard characterization: basic strategies and related technical issues, Exp. Toxicol. Pathol., 57, 227, 2005.
457. Linkov, I. and Satterstrom, F.K., Weight of evidence: what is the state of the science? Risk Anal., 26, 573, 2006.
458. Rietjens, I.M. and Alink, G.M., Future of toxicology: low-dose toxicology and risk-benefit analysis, Chem. Res. Toxicol., 19, 977, 2006.
459. Suter, W., Predictive value of in vitro safety studies. Curr. Opin. Chem. Biol., 10, 362, 2006.
460. van der Hoeven, N., Current issues in statistics and models for ecotoxicological risk assessment. Acta Biother., 52, 201, 2004.
461. Arias-Mendoza, F. et al., Methodological standardization for a multi-institutional in vivo trial of localized 31P MR spectroscopy in human cancer research: in vitro and normal volunteer studies, NMR Biomed., 17, 382, 2004.
462. Balls, M. and Combes, R., The need for a formal invalidation process for animal and nonanimal tests, Altern. Lab. Anim., 33, 299, 2005.
463. Combes, R., Barratt, M., and Balls, M., An overall strategy for the testing of chemicals for human hazard and risk assessment under the EU REACH system, Altern. Lab. Anim., 34, 15, 2006.
464. Gartlon, J. et al., Evaluation of a proposed in vitro test strategy using neuronal and nonneuronal cell systems for detecting neurotoxicity, Toxicol. in Vitro, 20, 1569, 2006.
465. Hoffmann, S. and Hartung, T., Designing validation studies more efficiently according to the modular approach: retrospective analysis of the Episkin test for skin corrosion, Altern. Lab. Anim., 34, 177, 2006.
466. Prieto, P. et al., The assessment of repeated dose toxicity in vitro: a proposed approach: report and recommendations of ECVAM workshop 56, Altern. Lab. Anim., 34, 315, 2006.
467. Spielmann, H. et al., The practical application of three validated in vitro embryotoxicity tests:report and recommendations of an ECVAM/ZEBET workshop, Altern. Lab. Anim., 34, 527, 2006.
468. Barile, F.A., Continuous cell lines as a model for drug toxicity assessment, in Introduction to In Vitro Methods in Pharmaceutical Research, Castell, J.V. and Gómez-Lechón, M.J., Eds., Academic Press, London, 1997.
469. Barile, F.A., Dierickx, P.J., and Kristen, U., In vitro cytotoxicity testing for prediction of acute human toxicity, Cell Biol. Toxicol., 10, 155, 1994.
470. Clemedson C. et al., MEIC evaluation of acute systemic toxicity I. Methodology of 68 in vitro toxicity assays used to test the first 30 reference chemicals, Altern. Lab. Anim., 24, 249, 1996.
471. Clemedson, C. et al., MEIC evaluation of acute systemic toxicity II. In vitro results from 68 toxicity assays used to test the first 30 reference chemicals and a comparative cytotoxicity analysis, Altern. Lab. Anim., 24, 273, 1996.
472. Clemedson, C. et al., MEIC evaluation of acute systemic toxicity III. In vitro results from 16 additional methods used to test the first 30 reference chemicals and a comparative cytotoxicity analysis, Altern. Lab. Anim., 26, 93, 1998.
473. Clemedson, C. et al., MEIC evaluation of acute systemic toxicity IV. In vitro results from 67 toxicity assays used to test reference chemicals 31-50 and a comparative cytotoxicity analysis, Altern. Lab. Anim., 26, 131, 1998.
474. Clemedson, C. et al., MEIC evaluation of acute systemic toxicity VII. Prediction of human toxicity by results from testing of the first 30 reference chemicals with 27 further in vitro assays, Altern. Lab. Anim., 28, 161, 2000.
475. Curren, R., Bruner, L., Goldberg, A., and Walum E., Validation and acute toxicity testing:13th meeting of Scientific Group on Methodologies for the Safety Evaluation of Chemicals, Environ. Health Perspect., 106, 419, 1998.
476. Edler, L. and Ittrich, C., Biostatistical methods for the validation of alternative methods for in vitro toxicity testing, Altern. Lab. Anim., 31, 5, 2003.
477. Ekwall, B., Overview of final MEIC results II. The in vitro-in vivo evaluation including the selection of a practical battery of cell tests for prediction of acute lethal blood concentrations in humans, Toxicol. in Vitro, 13, 665, 1999.
478. Ekwall, B. and Barile, F.A., Standardization and validation, in In Vitro Cytotoxicology:Mechanisms and Methods, CRC Press, Boca Raton, FL, 1994, p. 189.
479. Ekwall, B. et al., MEIC evaluation of acute systemic toxicity V. Rodent and human toxicity data for the 50 reference chemicals, Altern. Lab. Anim., 26, 569, 1998.
480. Halle, W., Spielmann, H., and Liebsch, M., Prediction of human lethal concentrations by cytotoxicity data from 50 MEIC chemicals, ALTEX, 17, 75, 2000.
481. Hellberg, S. et al., Analogy models for prediction of human toxicity, Altern. Lab. Anim., 18, 103, 1990.
482. Interagency Coordinating Committee on the Validation of Alternative Methods, Biennial Progress Report of the National Toxicology Program, Publication 04-4509, National Institute of Environmental Health Sciences, Research Triangle Park, NC, 2003. http://iccvam.niehs.nih.gov/about/annrpt/bienrpt044509.pdf.
483. Louekari, K., Status and prospects of in vitro tests in risk assessment, Altern. Lab. Anim., 32, 431, 2004.
484. Paris, M. et al., Phase I and II results of a validation study to evaluate in vitro cytotoxicity assays for estimating rodent and human acute systemic toxicity, 43rd Annual Meeting of Society of Toxicology, Toxicol. Sci., Abstract 240, 2004.
485. Rispin, A., Stitzel, K., Harbell, J., and Klausner, M., Ensuring quality of in vitro alternative test methods: current practice, Regul. Toxicol. Pharmacol., 45, 97, 2006.
486. Spielmann, H., Genschow, E., Leibsch, M., and Halle W., Determination of starting dose for acute oral toxicity (LD50) testing, Altern. Lab. Anim., 27, 957, 1999.
487. Ubels, J.L. and Clousing, D.P., In vitro alternatives to the use of animals in ocular toxicology testing, Ocul Surf., 3, 126, 2005.
488. Barile, F.A., Mechanisms of cytotxicology, in Introduction to In Vitro Cytotoxicology: Mechanisms and Methods, CRC Press, Boca Raton, FL, 1994, p. 27.
489. Ekwall, B., Basal cytotoxicity data (BC data) in human risk assessment, in Proceedings of Workshop on Risk Assessment and Risk Management of Toxic Chemicals, National Institute for Environmental Studies, Ibaraki, Japan, 1992, p. 137.
490. Ekwall, B., The basal cytotoxicity concept, in Alternative Methods in Toxicology and the Life Sciences, vol. 11, Goldberg, A. and van Zupten, L.F.M., Eds., Mary Ann Liebert, New York, 1995, p. 721.
491. Garthoff, B., Alternatives to animal experimentation: the regulatory background, Toxicol. Appl. Pharmacol., 207, 388, 2005.
492. Grindon, C. and Combes, R., Introduction to the EU REACH legislation, Altern. Lab. Anim., 34, 5. 2006.
493. Gupta, K., Rispin, A., Stitzel, K., Coecke, S., and Harbell, J., Ensuring quality of in vitro alternative test methods: issues and answers, Regul. Toxicol. Pharmacol., 43, 219, 2005.
494. Koeter, H.B., Dialogue and collaboration: a personal view on laboratory animal welfare developments in general, and on ECVAM’s first decade in particular, Altern. Lab. Anim., 30, 207, 2002.
495. Schechtman, L.M., Implementation of the 3Rs (refinement, reduction, and replacement):validation and regulatory acceptance considerations for alternative toxicological test methods, ILAR J., 43, S85, 2002.
496. Schechtman, L.M. and Stokes, W.S., ECVAM-ICCVAM: prospects for future collaboration, Altern. Lab. Anim., 30, 227, 2002.
497. Straughan, D., Progress in applying the three Rs to the potency testing of botulinum toxin type A, Altern. Lab. Anim., 34, 305, 2006.
498. Combes, R., Gaunt, I., and Balls, M.A., Scientific and animal welfare assessment of the OECD Health Effects Test Guidelines for the safety testing of chemicals under the European Union REACH system, Altern. Lab. Anim., 34, 77, 2006.
499. Edler, L. and Ittrich, C., Biostatistical methods for the validation of alternative methods for in vitro toxicity testing, Altern. Lab. Anim., 31, 5, 2003.
500. Gruber, F.P. and Hartung, T., Alternatives to animal experimentation in basic research, ALTEX, 21, 3, 2004.
501. Huggins, J., Alternatives to animal testing: research, trends, validation, regulatory acceptance, ALTEX, 20, 3, 2003.
502. Kirkland, D.J., Testing strategies in mutagenicity and genetic toxicology: an appraisal of the guidelines of the European Scientific Committee for Cosmetics and Non-Food Products for the evaluation of hair dyes, Mutat. Res., 588, 88, 2005.
503. Louekari, K., Status and prospects of in vitro tests in risk assessment, Altern. Lab. Anim., 32, 431, 2004.
504. Meyer, O., Testing and assessment strategies, including alternative and new approaches, Toxicol. Lett., 140, 21, 2003.
505. Rispin, A., Stitzel, K., Harbell, J. and Klausner, M., Ensuring quality of in vitro alternative test methods: current practice, Regul. Toxicol. Pharmacol., 45, 97, 2006.
506. Stokes, W.S., Schechtman, L.M., and Hill, R.N., The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): a review of the ICCVAM test method evaluation process and current international collaborations with the European Centre for the Validation of Alternative Methods (ECVAM), Altern. Lab. Anim., 30, 23, 2002.