메뉴 건너뛰기




Volumn 9, Issue 9, 2013, Pages 1171-1180

Dogs and monkeys in preclinical drug development: The challenge of reducing and replacing

Author keywords

3Rs; ADME; Animal experimentation; Safety; Toxicology

Indexed keywords

DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DEVELOPMENT; DRUG DISTRIBUTION; DRUG INDUSTRY; DRUG METABOLISM; DRUG SAFETY; DRUG SCREENING; ECHOGRAPHY; EXPERIMENTAL DOG; EXPERIMENTAL MONKEY; LAB ON A CHIP; NON INVASIVE MEASUREMENT; NONHUMAN; NUCLEAR MAGNETIC RESONANCE IMAGING; POSITRON EMISSION TOMOGRAPHY; REVIEW; RISK ASSESSMENT; STANDARD; STEM CELL; STUDY DESIGN; TISSUE DISTRIBUTION; TOXICITY TESTING;

EID: 84882314613     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1517/17425255.2013.804061     Document Type: Review
Times cited : (7)

References (77)
  • 1
    • 0004259456 scopus 로고    scopus 로고
    • Random House; New York, NY first published in 1975
    • Singer P. Animal liberation. Random House; New York, NY: 2009; first published in 1975
    • (2009) Animal Liberation
    • Singer, P.1
  • 3
    • 34547700118 scopus 로고    scopus 로고
    • The ethics of animal research
    • Festing S, Wilkinson R. The ethics of animal research. EMBO Rep 2007;8:526-30
    • (2007) EMBO Rep , vol.8 , pp. 526-530
    • Festing, S.1    Wilkinson, R.2
  • 4
    • 80052535785 scopus 로고    scopus 로고
    • Ethical and scientific considerations regarding animal testing and research
    • Ferdowsian HR, Beck N. Ethical and scientific considerations regarding animal testing and research. PLoS One 2011;9:e 24059
    • (2011) PLoS One , vol.9 , pp. 24059
    • Ferdowsian, H.R.1    Beck, N.2
  • 5
    • 84882367315 scopus 로고    scopus 로고
    • Scientific Committee on Health and Environment Risks (SCHER) Scientific opinion on the need for non-human primates in biomedical research, production and testing of products and devices. 2009
    • Scientific Committee on Health and Environment Risks (SCHER) Scientific opinion on the need for non-human primates in biomedical research, production and testing of products and devices. 2009. Available from: http://ec.europa.eu/ environment/chemicals/lab-animals/pdf/scher-o-110.pdf
  • 7
    • 1542758710 scopus 로고    scopus 로고
    • The 3Rs and animal welfare: Conflict or the way forward
    • Rusche B. The 3Rs and animal welfare: conflict or the way forward. ALTEX 2003;20:63-76
    • (2003) ALTEX , vol.20 , pp. 63-76
    • Rusche, B.1
  • 8
    • 84882384595 scopus 로고    scopus 로고
    • Directive 2010/63/EU of the European Parliament and of the Council of September 2010 on the protection of animals used for scientific purposes: L: 2010: 276: 0033: 0079: en: PDF
    • Directive 2010/63/EU of the European Parliament and of the Council of September 2010 on the protection of animals used for scientific purposes. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ: L:2010:276:0033:0079:en:PDF
  • 9
    • 79952316851 scopus 로고    scopus 로고
    • Comparative analysis of the revised directive 2010/63/EU for the protection of laboratory animals with its predecessor 86/809/EEC-A t4 report
    • Hartung T. Comparative analysis of the revised directive 2010/63/EU for the protection of laboratory animals with its predecessor 86/809/EEC-A t4 report. ALTEX 2010;27:285-303
    • (2010) ALTEX , vol.27 , pp. 285-303
    • Hartung, T.1
  • 10
    • 84882298993 scopus 로고    scopus 로고
    • Regulation (EC) of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and restriction of CHemicals (REACH). Official Journal of the European Union 30.12.2006. do?uri=OJ: L: 2007: 136: 0003: 0280: en: PDF
    • Regulation (EC) of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and restriction of CHemicals (REACH). Official Journal of the European Union 30.12.2006. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ. do?uri=OJ:L:2007:136:0003:0280:en:PDF
  • 11
    • 84882380824 scopus 로고    scopus 로고
    • Chemical safety for sustainability, Strategic Research Action plan 2012-2016. United States Environmental Protection Agency. EPA 601/R-12/006 June 2012
    • Chemical safety for sustainability, Strategic Research Action plan 2012-2016. United States Environmental Protection Agency. EPA 601/R-12/006 June 2012. Available from: http://www.epa.gov/research/docs/css-strap.pdf
  • 13
    • 84858776347 scopus 로고    scopus 로고
    • Activists ground primate flights
    • Wadman M. Activists ground primate flights. Nature 2012;483:381-2
    • (2012) Nature , vol.483 , pp. 381-382
    • Wadman, M.1
  • 14
    • 84882330315 scopus 로고    scopus 로고
    • Eurobarometer. Science and technology report. 2010
    • Eurobarometer. Science and technology report. 2010. Available from: http://ec.europa.eu/public-opinion/archives/ebs/ebs-340-en.pdf
  • 15
    • 84882308194 scopus 로고    scopus 로고
    • Sixth report on the statistics on the number of animals used for experimental and other scientific purposes in the member states of the European Union. Accompanying document. Available from: http://ec.europa.eu/environment/ bchemicals/lab-animals/pdf/sec-2010-1107.pdf 16. 2010 US statistics AWA report animal usage United States Department of Agriculture. 2011
    • Sixth report on the statistics on the number of animals used for experimental and other scientific purposes in the member states of the European Union. Accompanying document. Available from: http://ec.europa.eu/environment/ chemicals/lab-animals/pdf/sec-2010-1107.pdf 16. 2010 US statistics AWA report animal usage United States Department of Agriculture. 2011. Available from: http://www.aphis.usda.gov/animal-welfare/efoia/downloads/2010-Animals-Used-In- Research.pdf
  • 16
    • 84882319046 scopus 로고    scopus 로고
    • Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2) CPMP/ICH/286/95. 2009; The European Agency for the Evaluation of Medicinal Products. Human medicines evaluation unit
    • Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2) CPMP/ICH/286/95. 2009; The European Agency for the Evaluation of Medicinal Products. Human medicines evaluation unit. Available from: http://www.ema. europa.eu/docs/en-GB/ document-library/Scientific-guideline/2009/09/WC500002720.pdf
  • 17
    • 0033771951 scopus 로고    scopus 로고
    • Concordance of the toxicity of pharmaceuticals in humans and animals
    • Olson H, Betton G, Robinson D, et al. Concordance of the toxicity of pharmaceuticals in humans and animals. Regul Toxicol Pharmacol 2000;32:56-67
    • (2000) Regul Toxicol Pharmacol , vol.32 , pp. 56-67
    • Olson, H.1    Betton, G.2    Robinson, D.3
  • 18
    • 41849108479 scopus 로고    scopus 로고
    • Medical progress depends on animal models-doesn't it
    • Matthews RAJ. Medical progress depends on animal models-doesn't it? J R Soc Med 2008;101:95-8
    • (2008) J R Soc Med , vol.101 , pp. 95-98
    • Matthews, R.A.J.1
  • 19
    • 84873355257 scopus 로고    scopus 로고
    • Systematic reviews of animal models: Methodology versus epistemology
    • Greek R, Menache A. Systematic reviews of animal models: methodology versus epistemology. Int J Med Sci 2013;10(3):206-21
    • (2013) Int J Med Sci , vol.10 , Issue.3 , pp. 206-221
    • Greek, R.1    Menache, A.2
  • 20
    • 67650445156 scopus 로고    scopus 로고
    • Toxicology for the twenty-first century
    • Hartung T. Toxicology for the twenty-first century. Nature 2009;460:208-12
    • (2009) Nature , vol.460 , pp. 208-212
    • Hartung, T.1
  • 21
    • 84882398494 scopus 로고    scopus 로고
    • Animal Research for Life: "Recent examples of alternative methods developed by the pharmaceutical industry
    • Animal Research for Life: "Recent examples of alternative methods developed by the pharmaceutical industry". Available from: http: www. animalresearchforlife.euAlternatives
  • 22
    • 34548722771 scopus 로고    scopus 로고
    • Replacing animal experiments: Choices, changes and challenges
    • Langley G, Evans T, Holgate ST, et al. Replacing animal experiments: choices, changes and challenges. Bioessays 2007;29:918-26
    • (2007) Bioessays , vol.29 , pp. 918-926
    • Langley, G.1    Evans, T.2    Holgate, S.T.3
  • 23
    • 77749283710 scopus 로고    scopus 로고
    • Replacing, reducing and refining animal experiments: Making sound progress, but must do better
    • Balls M. Replacing, reducing and refining animal experiments: making sound progress, but must do better. ATLA 2009;37:579-80
    • (2009) ATLA , vol.37 , pp. 579-580
    • Balls, M.1
  • 24
    • 84858976293 scopus 로고    scopus 로고
    • Inroads to predict in vivo toxicology-An introduction to the eTOX project
    • Briggs K, Cases M, Heard DJ, et al. Inroads to predict in vivo toxicology-An introduction to the eTOX project. Int J Mol Sci 2012;13:3820-46
    • (2012) Int J Mol Sci , vol.13 , pp. 3820-3846
    • Briggs, K.1    Cases, M.2    Heard, D.J.3
  • 25
    • 84882428082 scopus 로고    scopus 로고
    • National Research Council (NCR). Toxicity testing in the 21st century: a vision and a strategy. National Academy Press. Washington DC
    • National Research Council (NCR). Toxicity testing in the 21st century: a vision and a strategy. National Academy Press. Washington DC. Available from: http://www.nap.edu/catalog.php?record-id=11970
  • 26
    • 59149106151 scopus 로고    scopus 로고
    • Toxicity testing in the 21st century: Bringing the vision to life
    • Andersen ME, Krewski D. Toxicity testing in the 21st century: bringing the vision to life. Toxicol Sci 2009;107(2):324-30
    • (2009) Toxicol Sci , vol.107 , Issue.2 , pp. 324-330
    • Andersen, M.E.1    Krewski, D.2
  • 27
    • 79955484701 scopus 로고    scopus 로고
    • Toxicology in the 21st century-working our way towards a visionary reality
    • Berg N, De Wever B, Fuchs HW. Toxicology in the 21st century-working our way towards a visionary reality. Toxicol in Vitro 2011;25:874-81
    • (2011) Toxicol in Vitro , vol.25 , pp. 874-881
    • Berg, N.1    De Wever, B.2    Fuchs, H.W.3
  • 28
    • 79952313498 scopus 로고    scopus 로고
    • From alternative methods to a new toxicology
    • Hartung T. From alternative methods to a new toxicology. Eur J Pharm Biopharm 2011;77:338-49
    • (2011) Eur J Pharm Biopharm , vol.77 , pp. 338-349
    • Hartung, T.1
  • 29
    • 73649133282 scopus 로고    scopus 로고
    • A 1 year toxicity in dogs is no longer a scientifically justifiable core-data requirement for the safety assessment of pesticides
    • Kobel W, Fegert I, Billington R, et al. A 1 year toxicity in dogs is no longer a scientifically justifiable core-data requirement for the safety assessment of pesticides. Critical Rev Toxicol 2010;40(1):1-15
    • (2010) Critical Rev Toxicol , vol.40 , Issue.1 , pp. 1-15
    • Kobel, W.1    Fegert, I.2    Billington, R.3
  • 30
    • 73649133977 scopus 로고    scopus 로고
    • The mouse carcinogenicity study is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides
    • Billington R, Lewis RW, Mehta JM, Dewhurst I. The mouse carcinogenicity study is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides. Crit Rev Toxicol 2010;40(1):35-49
    • (2010) Crit Rev Toxicol , vol.40 , Issue.1 , pp. 35-49
    • Billington, R.1    Lewis, R.W.2    Mehta, J.M.3    Dewhurst, I.4
  • 31
    • 84882433090 scopus 로고    scopus 로고
    • ICH guideline S6(R1): preclinical safety evaluation of biotechnology-derived pharmaceuticals. Step EMA/CHMP/ICH/731268/1998
    • ICH guideline S6(R1): preclinical safety evaluation of biotechnology-derived pharmaceuticals. Step EMA/CHMP/ICH/731268/1998. Available from: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/ 2009/09/WC500002828.pdf
  • 32
    • 84455189541 scopus 로고    scopus 로고
    • Critical evaluation of the use of dogs in biomedical research and testing
    • Zurlo J, Bayne KA, Brown DC, et al. Critical evaluation of the use of dogs in biomedical research and testing. ALTEX 2011;28:355-9
    • (2011) ALTEX , vol.28 , pp. 355-359
    • Zurlo, J.1    Bayne, K.A.2    Brown, D.C.3
  • 33
    • 78549259732 scopus 로고    scopus 로고
    • ICH guidelines: Inception, revision and implications for drug development
    • Wang T, Jacobson-Kram D, Pilaro AM, et al. ICH guidelines: inception, revision and implications for drug development. Toxicol Sci 2010;118(2):356-67
    • (2010) Toxicol Sci , vol.118 , Issue.2 , pp. 356-367
    • Wang, T.1    Jacobson-Kram, D.2    Pilaro, A.M.3
  • 34
    • 85019916253 scopus 로고    scopus 로고
    • ADME studies in animals and humans
    • In: Zhang D, Zhu M, Humphreys WG, editors Drug metabolism in drug design and development". John Wiley & sons, Inc, Hoboken, NJ, USA
    • Zhang D, Comezoglu SN. ADME studies in animals and humans. In: Zhang D, Zhu M, Humphreys WG, editors. Experimental design, metabolite profiling and identification, and data presentation in "Drug metabolism in drug design and development". John Wiley & sons, Inc, Hoboken, NJ, USA; 2008
    • (2008) Experimental Design, Metabolite Profiling and Identification, and Data Presentation in
    • Zhang, D.1    Comezoglu, S.N.2
  • 35
    • 84872163274 scopus 로고    scopus 로고
    • Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: A commentary on why they are still necessary
    • White RE, Evans DC, Hop CE, et al. Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: a commentary on why they are still necessary. Xenobiotica 2013;43:219-25
    • (2013) Xenobiotica , vol.43 , pp. 219-225
    • White, R.E.1    Evans, D.C.2    Hop, C.E.3
  • 36
    • 82955193812 scopus 로고    scopus 로고
    • Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: Are they still necessary
    • Obach RS, Nedderman AN, Smith DA. Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: are they still necessary? Xenobiotica 2012;42:46-56
    • (2012) Xenobiotica , vol.42 , pp. 46-56
    • Obach, R.S.1    Nedderman, A.N.2    Smith, D.A.3
  • 37
    • 84856092196 scopus 로고    scopus 로고
    • Preclinical in vivo ADME studies in drug development: A critical review
    • Pellegatti M. Preclinical in vivo ADME studies in drug development: a critical review. Expert Opin Drug Metab Toxicol 2012;8(2):161-72
    • (2012) Expert Opin Drug Metab Toxicol , vol.8 , Issue.2 , pp. 161-172
    • Pellegatti, M.1
  • 38
    • 84455181545 scopus 로고    scopus 로고
    • Critical evaluation of the use of dogs in biomedical research and testing in Europe
    • Hasiwa N, Bailey J, Clausing P, et al. Critical evaluation of the use of dogs in biomedical research and testing in Europe. ALTEX 2011;28:326-40
    • (2011) ALTEX , vol.28 , pp. 326-340
    • Hasiwa, N.1    Bailey, J.2    Clausing, P.3
  • 39
    • 77957226434 scopus 로고    scopus 로고
    • The RETHINK Project: Minipig as models for the toxicity testing of new medicines and chemicals: An impact assessment
    • Forster R, Bode G, Ellegard L, et al. The RETHINK Project: minipig as models for the toxicity testing of new medicines and chemicals: an impact assessment. J Pharmacol Toxicol Methods 2010;62:158-9
    • (2010) J Pharmacol Toxicol Methods , vol.62 , pp. 158-159
    • Forster, R.1    Bode, G.2    Ellegard, L.3
  • 40
    • 77957226435 scopus 로고    scopus 로고
    • The RETHINK project on minipigs in the toxicity testing of new medicines and chemicals: Conclusions and recommendations
    • Forster R, Bode G, Ellegard L, et al. The RETHINK project on minipigs in the toxicity testing of new medicines and chemicals: conclusions and recommendations. J Pharmacol Toxicol Methods 2010;62:236-42
    • (2010) J Pharmacol Toxicol Methods , vol.62 , pp. 236-242
    • Forster, R.1    Bode, G.2    Ellegard, L.3
  • 41
    • 84872440155 scopus 로고    scopus 로고
    • Animal models of toxicology testing: The role of pigs
    • Helke KL, Swindle MM. Animal models of toxicology testing: the role of pigs. Expert Opin Drug Metab Toxicol 2013;98(2):127-39
    • (2013) Expert Opin Drug Metab Toxicol , vol.98 , Issue.2 , pp. 127-139
    • Helke, K.L.1    Swindle, M.M.2
  • 43
    • 29444441457 scopus 로고    scopus 로고
    • Non-human primates in medical research and drug development: A critical review
    • Bailey J. Non-human primates in medical research and drug development: a critical review. Biog Amines 2005;19:235-55
    • (2005) Biog Amines , vol.19 , pp. 235-255
    • Bailey, J.1
  • 44
    • 84882435664 scopus 로고    scopus 로고
    • Great Ape Protection and Cost Saving Act of 2011
    • Great Ape Protection and Cost Saving Act of 2011. Available from: http://www.govtrack.us/congress/bills/112/s810/text
  • 46
    • 80054800557 scopus 로고    scopus 로고
    • Considerations regarding nonhuman primate use in safety assessment of biopharmaceuticals
    • Buckley LA, Chapman K, Burns-Naas LA, et al. Considerations regarding nonhuman primate use in safety assessment of biopharmaceuticals. Int J Toxicol 2011;30:583-90
    • (2011) Int J Toxicol , vol.30 , pp. 583-590
    • Buckley, L.A.1    Chapman, K.2    Burns-Naas, L.A.3
  • 47
    • 84857372735 scopus 로고    scopus 로고
    • The design of chronic toxicology studies on monoclonal antibodies: Implications for reduction in the use of non-human primates
    • Chapman KL, Andrews L, Bjramovic JJ, et al. The design of chronic toxicology studies on monoclonal antibodies: implications for reduction in the use of non-human primates. Regul Toxicol Pharmacol 2012;62(2):347-54
    • (2012) Regul Toxicol Pharmacol , vol.62 , Issue.2 , pp. 347-354
    • Chapman, K.L.1    Andrews, L.2    Bjramovic, J.J.3
  • 48
    • 84863230445 scopus 로고    scopus 로고
    • Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration
    • Zheng Y, Tesar DB, Benincasa L, et al. Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration. MAbs 2012;4(2):243-55
    • (2012) MAbs , vol.4 , Issue.2 , pp. 243-255
    • Zheng, Y.1    Tesar, D.B.2    Benincasa, L.3
  • 49
    • 84875838049 scopus 로고    scopus 로고
    • A new approach to predicting human hepatic clearance of CYP3A4 substrates using monkey pharmacokinetic data
    • Ogawa K, Kato M, Honjo T, et al. A new approach to predicting human hepatic clearance of CYP3A4 substrates using monkey pharmacokinetic data. Xenobiotica 2013;43:468-78
    • (2013) Xenobiotica , vol.43 , pp. 468-478
    • Ogawa, K.1    Kato, M.2    Honjo, T.3
  • 50
    • 2442680354 scopus 로고    scopus 로고
    • A comprehensive and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog and monkey to humans
    • Ward KW, Smith BR. A comprehensive and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog and monkey to humans. I Clearance. Drug Met Dis 2004;32:603-11
    • (2004) I Clearance. Drug Met Dis , vol.32 , pp. 603-611
    • Ward, K.W.1    Smith, B.R.2
  • 51
    • 78751499845 scopus 로고    scopus 로고
    • Quantitative prediction of human pharmacokinetics for monoclonal antibodies: Retrospective analysis of monkey as a single species for first-in-human prediction
    • Dong JQ, Salinger DH, Christopher J, et al. Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction. Clin Pharmacokinet 2011;50(2):131-42
    • (2011) Clin Pharmacokinet , vol.50 , Issue.2 , pp. 131-142
    • Dong, J.Q.1    Salinger, D.H.2    Christopher, J.3
  • 52
    • 0026621257 scopus 로고
    • Problems and opportunities in toxicity testing arising from species differences in xenobiotic metabolism
    • Caldwell J. Problems and opportunities in toxicity testing arising from species differences in xenobiotic metabolism. Toxicol Lett 1992;64-65:651-9
    • (1992) Toxicol Lett , vol.64-65 , pp. 651-659
    • Caldwell, J.1
  • 53
    • 79954522718 scopus 로고    scopus 로고
    • Species differences between cynomolgus monkey and humans on Cytochrome P450 2D and 3A-dependent drug oxidation activities in liver microsomes
    • Emoto C, Iwasaki K, Koizumi R, et al. Species differences between cynomolgus monkey and humans on Cytochrome P450 2D and 3A-dependent drug oxidation activities in liver microsomes. J Health Sci 2011;57(2):164-70
    • (2011) J Health Sci , vol.57 , Issue.2 , pp. 164-170
    • Emoto, C.1    Iwasaki, K.2    Koizumi, R.3
  • 54
    • 76149110084 scopus 로고    scopus 로고
    • A comparison of pharmacokinetics between humans and monkeys
    • Akabane T, Tabata K, Kadono K, et al. A comparison of pharmacokinetics between humans and monkeys. Drug Metabol Dispos 2010;38(2):308-16
    • (2010) Drug Metabol Dispos , vol.38 , Issue.2 , pp. 308-316
    • Akabane, T.1    Tabata, K.2    Kadono, K.3
  • 55
    • 84555187264 scopus 로고    scopus 로고
    • Integration of dosimetry, exposure, and high-throughput data in chemical toxicity assessment
    • Wetmore BA, Wambaugh J, Ferguson SS, et al. Integration of dosimetry, exposure, and high-throughput data in chemical toxicity assessment. Toxicol Sci 2012;125(1):157-74
    • (2012) Toxicol Sci , vol.125 , Issue.1 , pp. 157-174
    • Wetmore, B.A.1    Wambaugh, J.2    Ferguson, S.S.3
  • 56
    • 78549237487 scopus 로고    scopus 로고
    • The use of in vitro toxicity data and physiologically based kinetic modeling to predict dose-response curves for in vivo developmental toxicity of glycol ethers in rat and man
    • Louisse J, de Jong E, van de Sandt JJM, et al. The use of in vitro toxicity data and physiologically based kinetic modeling to predict dose-response curves for in vivo developmental toxicity of glycol ethers in rat and man. Toxicol Sci 2010;118(2):470-84
    • (2010) Toxicol Sci , vol.118 , Issue.2 , pp. 470-484
    • Louisse, J.1    De Jong, E.2    Van De Sandt, J.J.M.3
  • 57
    • 84864910252 scopus 로고    scopus 로고
    • Cutting edge PBPK models and analyses: Providing the basis for future modeling efforts and bridges to emerging toxicology paradigms
    • article ID 852384
    • Caldwell JC, Evans MV, Krishnan K. Cutting edge PBPK models and analyses: providing the basis for future modeling efforts and bridges to emerging toxicology paradigms. J Toxicol 2012;2012:article ID 852384
    • (2012) J Toxicol , vol.2012
    • Caldwell, J.C.1    Evans, M.V.2    Krishnan, K.3
  • 58
    • 84882355084 scopus 로고    scopus 로고
    • Alternative testing strategies. Progress report 2012. European Commission. European research area
    • Alternative testing strategies. Progress report 2012. European Commission. European research area. Available from: http://axlr8.eu/assets/ axlr8-progress-report-2012.pdf
  • 59
    • 79958288447 scopus 로고    scopus 로고
    • Current standing and future prospects for the technologies proposed to transform toxicity testing in the 21st century
    • Van Vliet E. Current standing and future prospects for the technologies proposed to transform toxicity testing in the 21st century. ALTEX 2011;28:17-44
    • (2011) ALTEX , vol.28 , pp. 17-44
    • Van Vliet, E.1
  • 60
    • 84872269827 scopus 로고    scopus 로고
    • Organotypic cultures of HepG2 cells for in vitro toxicity studies
    • Mueller D, Koetemann A, Noor F. Organotypic cultures of HepG2 cells for in vitro toxicity studies. J Bioengineer Biomedical Sci 2011;S2:002
    • (2011) J Bioengineer Biomedical Sci , vol.S2 , pp. 002
    • Mueller, D.1    Koetemann, A.2    Noor, F.3
  • 61
    • 79954447513 scopus 로고    scopus 로고
    • Present state and future perspectives of using pluripotent stem cells in toxicology research
    • Wobus AM, Loser P. Present state and future perspectives of using pluripotent stem cells in toxicology research. Arch Toxicol 2011;85:79-117
    • (2011) Arch Toxicol , vol.85 , pp. 79-117
    • Wobus, A.M.1    Loser, P.2
  • 62
    • 84873894054 scopus 로고    scopus 로고
    • Three dimensionally engineered biomimetic tissue models for in vitro drug evaluation: Delivery, efficacy and toxicity
    • Peck Y, Wang DA. Three dimensionally engineered biomimetic tissue models for in vitro drug evaluation: delivery, efficacy and toxicity. Exp Opin Drug Deliv 2013;10(3):369-83
    • (2013) Exp Opin Drug Deliv , vol.10 , Issue.3 , pp. 369-383
    • Peck, Y.1    Wang, D.A.2
  • 63
    • 77955785233 scopus 로고    scopus 로고
    • Integration of in silico and in vitro platforms for PK-PD modelling
    • Sung JH, Esh MB, Shuler ML. Integration of in silico and in vitro platforms for PK-PD modelling. Expert Opin Drug Metab Toxicol 2010;6:1063-81
    • (2010) Expert Opin Drug Metab Toxicol , vol.6 , pp. 1063-1081
    • Sung, J.H.1    Esh, M.B.2    Shuler, M.L.3
  • 65
    • 49249103327 scopus 로고    scopus 로고
    • Cellular imaging prediction of clinical drug induced liver injury
    • Xu JX, Henstock PV, Dunn MC, et al. Cellular imaging prediction of clinical drug induced liver injury. Toxicol Sci 2008;105:97-105
    • (2008) Toxicol Sci , vol.105 , pp. 97-105
    • Xu, J.X.1    Henstock, P.V.2    Dunn, M.C.3
  • 66
    • 55049116679 scopus 로고    scopus 로고
    • Biomedical imaging in the safety evaluation of new drugs Lab Anim
    • Wang YXS, Yan SX. Biomedical imaging in the safety evaluation of new drugs Lab Anim 2008; 42: 423-41
    • (2008) Pharmazie , vol.42 , pp. 423-41
    • Wang, Y.X.S.1    Yan, S.X.2
  • 67
    • 77949898228 scopus 로고    scopus 로고
    • The use of computer models in pharmaceutical safety evaluation
    • Boyer S. The use of computer models in pharmaceutical safety evaluation. ATLA 2009;37:467-75
    • (2009) ATLA , vol.37 , pp. 467-475
    • Boyer, S.1
  • 68
    • 84858858717 scopus 로고    scopus 로고
    • Application of advanced in silico methods for predictive modelling and information integration
    • Valerio LG. Application of advanced in silico methods for predictive modelling and information integration. Exp Opin Drug Metab Toxicol 2012;8(4):395-8
    • (2012) Exp Opin Drug Metab Toxicol , vol.8 , Issue.4 , pp. 395-398
    • Valerio, L.G.1
  • 69
    • 84859178050 scopus 로고    scopus 로고
    • Computational prediction of metabolism: Sites, products, SAR, P450 enzyme dynamics and mechanisms
    • Kirchmair J, Williamson MJ, Tyzack JD, et al. Computational prediction of metabolism: sites, products, SAR, P450 enzyme dynamics and mechanisms. J Chem Inf Model 2012;52:617-48
    • (2012) J Chem Inf Model , vol.52 , pp. 617-648
    • Kirchmair, J.1    Williamson, M.J.2    Tyzack, J.D.3
  • 71
    • 80052268766 scopus 로고    scopus 로고
    • Towards an integrated human clearance prediction strategy that minimises animal use
    • Beaumont K, Gardner I, Chapman K, et al. Towards an integrated human clearance prediction strategy that minimises animal use. J Pharm Sci 2011;100:4518-35
    • (2011) J Pharm Sci , vol.100 , pp. 4518-4535
    • Beaumont, K.1    Gardner, I.2    Chapman, K.3
  • 72
    • 6444244789 scopus 로고    scopus 로고
    • Preclinical safety evaluation using non rodent species: An industry/welfare project to minimise dog use
    • Smith D, Broadhead C, Descartes G, et al. Preclinical safety evaluation using non rodent species: an industry/welfare project to minimise dog use. ILAR J 2002;43:S39-42
    • (2002) ILAR J , vol.43
    • Smith, D.1    Broadhead, C.2    Descartes, G.3
  • 73
    • 70449706122 scopus 로고    scopus 로고
    • The end of monkey research
    • Suran M, Wolinsky H. The end of monkey research. EMBO Rep 2009;10(10):1080-2
    • (2009) EMBO Rep , vol.10 , Issue.10 , pp. 1080-1082
    • Suran, M.1    Wolinsky, H.2
  • 74
    • 84882429801 scopus 로고    scopus 로고
    • Animal research info. The global resource for scientific evidence in animal research
    • Animal research info. The global resource for scientific evidence in animal research. Available from: http://animalresearch. info/en
  • 75
    • 80053108853 scopus 로고    scopus 로고
    • Understanding pharmacology in humans: Phase 1 and phase
    • MerloPich E. Understanding pharmacology in humans: phase 1 and phase Curr Opin Pharmacol 2011;11:557-62
    • (2011) Curr Opin Pharmacol , vol.11 , pp. 557-562
    • Merlopich, E.1
  • 76
    • 41349119550 scopus 로고    scopus 로고
    • Mechanism-based pharmacokinetic-pharmacodynamic modelling in translational drug research
    • Danhof M, de Lange EC, Della Pasqua OE, et al. Mechanism-based pharmacokinetic-pharmacodynamic modelling in translational drug research. Trends Pharmacol Sci 2008;29(4):186-91
    • (2008) Trends Pharmacol Sci , vol.29 , Issue.4 , pp. 186-191
    • Danhof, M.1    De Lange, E.C.2    Della Pasqua, O.E.3
  • 77
    • 84865322934 scopus 로고    scopus 로고
    • Investigative safety science as a competitive advantage for Pharma
    • Moggs J, Moulin P, Pognan F, et al. Investigative safety science as a competitive advantage for Pharma. Expert Opin Drug Metab Toxicol 2012;8(9):1071-82
    • (2012) Expert Opin Drug Metab Toxicol , vol.8 , Issue.9 , pp. 1071-1082
    • Moggs, J.1    Moulin, P.2    Pognan, F.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.