Toxicologic Pathology in the 21st Century

Toxicologic Pathology

Volumn 41, Issue 5, 2013, Pages 689-708

  Ettlin, Robert A ^a  

^a Ettlin Consulting Ltd   (Switzerland)

Author keywords

alternative models in toxicology; animal models; biomarkers; computer data image collection; discovery pathology; mechanisms of toxicity; toxicologic pathology

Indexed keywords

AGRICULTURAL CHEMICAL; BIOLOGICAL MARKER;

ADULT RESPIRATORY DISTRESS SYNDROME; ARTIFICIAL INTELLIGENCE; AUTOMATION; BUDGET; COMPUTER; COMPUTER MODEL; DISEASE SEVERITY; DNA MODIFICATION; FINANCIAL MANAGEMENT; HUMAN; IMAGE ANALYSIS; IN VITRO STUDY; IN VIVO STUDY; MICROSCOPE; NONHUMAN; PATHOLOGIST; PATHOLOGY; PATHOPHYSIOLOGY; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; SOCIAL ASPECT; SYSTEMS BIOLOGY; TELEPATHOLOGY; TOXICOGENOMICS; TOXICOLOGIC PATHOLOGY; TOXICOLOGY; TOXICOPATHOLOGIST;

ALTERNATIVE MODELS IN TOXICOLOGY; ANIMAL MODELS; BIOMARKERS; COMPUTER DATA/IMAGE COLLECTION; DISCOVERY PATHOLOGY; MECHANISMS OF TOXICITY.; TOXICOLOGIC PATHOLOGY;

ANIMALS; BIOLOGICAL MARKERS; DISEASE MODELS, ANIMAL; HUMANS; PATHOLOGY; TOXICOLOGY;

ANIMALIA;

EID: 84879488904     PISSN: 01926233     EISSN: 15331601     Source Type: Journal    
DOI: 10.1177/0192623312466192     Document Type: Article

References (121)

1. Afshari C. A. Hamadeh H. K. Bushel P. R. (2011). The evolution of bioinformatics in toxicology: Advancing toxicogenomics. Toxicol Sci 120 Suppl 1, S225–37.
2. Andersen M. E. Al-Zoughool M. Croteau M. Westphal M. Krewski D. (2010). The future of toxicity testing. J Toxicol Environ Health B Crit Rev 13, 163–96.
3. Andersen M. E. Krewski D. (2009). Toxicity testing in the 21st century: Bringing the vision to life. Toxicol Sci 107, 324–30.
4. Astashkina A. Mann B. Grainger D. W. (2012). A critical evaluation of in vitro cell culture models for high-throughput drug screening and toxicity. Pharmacol Ther 134, 82–106.
5. Attarwala H. (2010). TGN1412: From discovery to disaster. J Young Pharm 2, 332–36.
6. Bach F. H. Winkler H. Wrighton C. J. Robson S. C. Stuhlmeier K. Ferran C. (1996). Xenotransplantation: A possible solution to the shortage of donor organs. Transplant Proc 28, 416–17.
7. Bagci U. Bray M. Caban J. Yao J. Mollura D. J. (2012). Computer-assisted detection of infectious lung diseases: A review. Comput Med Imaging Graph 36, 72–84.
8. Bailey J. (2005). Non-human primates in medical research and drug development: A critical review. Biogenic Amines 19, 235–55.
9. Bailey J. Taylor K. (2009). The SCHER report on non-human primate research — biased and deeply flawed. Altern Lab Anim 37, 427–35.
10. Berg N. De Wever B. Fuchs H. W. Gaca M. Krul C. Roggen E. L. (2011). Toxicology in the 21st century–working our way towards a visionary reality. Toxicol in Vitro 25, 874–81.
11. Bhogal N. (2010). Immunotoxicity and immunogenicity of biopharmaceuticals: Design concepts and safety assessment. Curr Drug Saf 5, 293–307.
12. Bhogal N. Grindon C. Combes R. Balls M. (2005). Toxicity testing: Creating a revolution based on new technologies. Trends Biotechnol 23, 299–307.
13. Blaauboer B. J. (2008). The contribution of in vitro toxicity data in hazard and risk assessment: Current limitations and future perspectives. Toxicol Lett 180, 81–84.
14. Bode G. Clausing P. Gervais F. Loegsted J. Luft J. Nogues V. Sims J. (2010). The utility of the minipig as an animal model in regulatory toxicology. J Pharmacol Toxicol Methods 62, 196–220.
15. Bolon B. Barale-Thomas E. Bradley A. Ettlin R. A. Franchi C. A. George C. Giusti A. M. Hall R. Jacobsen M. Konishi Y. Ledieu D. Morton D. Park J. H. Scudamore C. L. Tsuda H. Vijayasarathi S. K. Wijnands M. V. (2011). International recommendations for training future toxicologic pathologists participating in regulatory-type, nonclinical toxicity studies. Exp Toxicol Pathol 63, 187–95.
16. Boverhof D. R. Chamberlain M. P. Elcombe C. R. Gonzalez F. J. Heflich R. H. Hernandez L. G. Jacobs A. C. Jacobson-Kram D. Luijten M. Maggi A. Manjanatha M. G. Benthem J. Gollapudi B. B. (2011). Transgenic animal models in toxicology: Historical perspectives and future outlook. Toxicol Sci 121, 207–33.
17. Brauchli K. Oberholzer M. (2005). The iPath telemedicine platform. J Telemed Telecare 11 Suppl 2, S3–7.
18. Brauchli K. O'Mahony D. Banach L. Oberholzer M. (2005). iPath—A telemedicine platform to support health providers in low resource settings. Stud Health Technol Inform 114, 11–17.
19. Bretz F. Schmidli H. Konig F. Racine A. Maurer W. (2006). Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: General concepts. Biom J 48, 623–34.
20. Burbach G. J. Zuberbier T. (2011). Diagnosis of drug-induced skin reactions: A future role for computer-aided systems? Curr Opin Allergy Clin Immunol 11, 451–56.
21. Burns M. J. (2001). The pharmacology and toxicology of atypical antipsychotic agents. J Toxicol Clin Toxicol 39, 1–14.
22. Campus Medicus®. (n.d.). A software for diagnostic decision support, teleteaching and documentation. Accessed July 15, 2012. https://campusmedicus.com/more.
23. Cohen S. M. (2010). Evaluation of possible carcinogenic risk to humans based on liver tumors in rodent assays: The two-year bioassay is no longer necessary. Toxicol Pathol 38, 487–501.
24. Collings F. B. Vaidya V. S. (2008). Novel technologies for the discovery and quantitation of biomarkers of toxicity. Toxicology 245, 167–74.
25. Cortes-Mateos M. J. Martin D. Sandoval S. Ruidiaz M. E. Messmer D. Wang-Rodriguez J. Trogler W. Kummel A. C. Blair S. L. (2009). Automated microscopy to evaluate surgical specimens via touch prep in breast cancer. Ann Surg Oncol 16, 709–20.
26. Decordier I. Papine A. Vande Loock K. Plas G. Soussaline F. Kirsch-Volders M. (2011). Automated image analysis of micronuclei by IMSTAR for biomonitoring. Mutagenesis 26, 163–68.
27. Demartines N. Battegay E. Liebermann J. Oberholzer M. Rufli T. Harder F. (2000). Telemedicine: Perspectives and multidisciplinary approach. Schweiz Med Wochenschr 130, 314–23.
28. Derelanko M. J. Hollinger M. A. (2002). Handbook of Toxicology. CRC Press, Boca Raton, FL.
29. Deschl U. Kittel B. Rittinghausen S. Morawietz G. Kohler M. Mohr U. Keenan C. (2002). The value of historical control data–scientific advantages for pathologists, industry and agencies. Toxicol Pathol 30, 80–87.
30. Desoize B. Robert J. (1994). Individual dose adaptation of anticancer drugs. Eur J Cancer 30A, 844–51.
31. EC. (1976). Council directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC). Accessed July 15, 2012. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1976L0768:20100301:en:PDF
32. EC. (2010). 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. SEC 1107. Accessed July 15, 2012. http://ec.europa.eu/environment/chemicals/lab_animals/pdf/com_2010_511.pdf.
33. ECHA. (n.d.). Guidance on REACH and CLP implementation. Accessed July 15, 2012. http://echa.europa.eu/web/guest/support/guidance-on-reach-and-clp-implementation.
34. ECVAM. (n.d.). European Center for the Validation of Alternative Methods. Accessed July 15, 2012. http://ecvam.jrc.it/.
35. European Parliament. (2010). Directive 2010/63/EU of the European parliament and of the council of 22 September 2010 on the protection of animals used for scientific purposes. Accessed July 15, 2012. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:EN:PDF.
36. Ettlin R. A. Bolon B. Pyrah I. Konishi Y. Black H. E. (2009). Global recognition of qualified toxicologic pathologists: Credential review as a potential route for recognizing the proficiency of pathologists involved in regulatory-type nonclinical studies. Toxicol Pathol 37, 553–61.
37. Ettlin R. A. Kuroda J. Plassmann S. Prentice D. E. (2010a). Successful drug development despite adverse preclinical findings. Part 1: Processes to address issues and most important findings. J Toxicol Pathol 23, 189–211.
38. Ettlin R. A. Kuroda J. Plassmann S. Hayashi M. Prentice D. E. (2010b). Successful drug development despite adverse preclinical findings. Part 2: Examples. J Toxicol Pathol 23, 213–34.
39. Ettlin R. A. Oberholzer M. Perentes E. Ryffel B. Kolopp M. Qureshi S. R. (1991). A brief review of modern toxicologic pathology in regulatory and explanatory toxicity studies of chemicals. Arch Toxicol 65, 445–53.
40. Ferran C. Badrichani A. Z. Cooper J. T. Stroka D. M. Bach F. H. (1997). Xenotransplantation: Progress toward clinical development. Adv Nephrol Necker Hosp 27, 391–420.
41. Firestone M. Kavlock R. Zenick H. Kramer M. (2010). The U.S. Environmental Protection Agency strategic plan for evaluating the toxicity of chemicals. J Toxicol Environ Health B Crit Rev 13, 139–62.
42. Flockhart D. A. Yasuda S. U. Honig P. Rosebraugh C. Woosley R.L. (2009). Preventable adverse drug reactions: A focus on drug interactions. Accessed July 15, 2012. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm110632.htm.
43. Fraenkel L. Fried T. R. (2010). Individualized medical decision making: Necessary, achievable, but not yet attainable. Arch Intern Med 170, 566–69.
44. Friede T. Parsons N. Stallard N. Todd S. Valdes Marquez E. Chataway J. Nicholas R. (2011). Designing a seamless phase II/III clinical trial using early outcomes for treatment selection: An application in multiple sclerosis. Stat Med 30, 1528–40.
45. Friedman M. A. Woodcock J. Lumpkin M. M. Shuren J. E. Hass A. E. Thompson L. J. (1999). The safety of newly approved medicines: Do recent market removals mean there is a problem? JAMA 281, 1728–34.
46. Gad S. C. (2007). Animal Models in Toxicology. CRC/Taylor & Francis, Boca Raton, FL.
47. Gillett N. A. Chan C. M. (1999). Molecular pathology in the preclinical development of biopharmaceuticals. Toxicol Pathol 27, 48–52.
48. Gleeson M. P. Modi S. Bender A. Robinson R. L. Kirchmair J. Promkatkaew M. Hannongbua S. Glen R. C. (2012). The challenges involved in modeling toxicity data in silico: A review. Curr Pharm Des 18, 1266–91.
49. Goldenberg R. Peled N. (2011). Computer-aided simple triage. Int J Comput Assist Radiol Surg 6, 705–11.
50. Gomase V. S. Tagore S. Kale K. V. (2008). Microarray: An approach for current drug targets. Curr Drug Metab 9, 221–31.
51. Graf C. Wager E. Bowman A. Fiack S. Scott-Lichter D. Robinson A. (2007). Best practice guidelines on publication ethics: A publisher's perspective. Int J Clin Pract Suppl, 1–26.
52. Gribaldo L. (2007). Overview of alternative methodologies in toxicology. Accessed October 26, 2012. http://www.currentprotocols.com/WileyCDA/CPUnit/refId-tx2001.html.
53. Hartung T. (2010). Comparative analysis of the revised Directive 2010/63/EU for the protection of laboratory animals with its predecessor 86/609/EEC – a t4 report. Altex 27, 285–303.
54. Horne B. D. Lenzini P. A. Wadelius M. Jorgensen A. L. Kimmel S. E. Ridker P. M. Eriksson N. Anderson J. L. Pirmohamed M. Limdi N. A. Pendleton R. C. McMillin G. A. Burmester J. K. Kurnik D. Stein C. M. Caldwell M. D. Eby C. S. Rane A. Lindh J. D. Shin J. G. Kim H. S. Angchaisuksiri P. Glynn R. J. Kronquist K. E. Carlquist J. F. Grice G. R. Barrack R. L. Li J. Gage B. F. (2012). Pharmacogenetic warfarin dose refinements remain significantly influenced by genetic factors after one week of therapy. Thromb Haemost 107, 232–40.
55. Hubbs A. F. Mercer R. R. Benkovic S. A. Harkema J. Sriram K. Schwegler-Berry D. Goravanahally M. P. Nurkiewicz T. R. Castranova V. Sargent L. M. (2011). Nanotoxicology—A pathologist's perspective. Toxicol Pathol 39, 301–24.
56. ICH (2012). Concept paper – S1: rodent carcinogenicity studies for human pharmaceuticals. Accessed July 15, 2012. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S1/S1_Final_Concept_Paper_April_2012.pdf.
57. Ito R. Takahashi T. Katano I. Ito M. (2012). Current advances in humanized mouse models. Cell Mol Immunol 9, 208–14.
58. Jacobson-Kram D. (2010). Cancer risk assessment approaches at the FDA/CDER: Is the era of the 2-year bioassay drawing to a close? Toxicol Pathol 38, 169–70.
59. Johnson D. E. Rodgers A. D. (2006). Computational toxicology: Heading toward more relevance in drug discovery and development. Curr Opin Drug Discov Devel 9, 29–37.
60. Johnson K. A. (2007). Imaging techniques for small animal imaging models of pulmonary disease: Micro-CT. Toxicol Pathol 35, 59–64.
61. Kandarova H. Letasiova S. (2011). Alternative methods in toxicology: Pre-validated and validated methods. Interdiscip Toxicol 4, 107–13.
62. Kayser K. Gortler J. Bogovac M. Bogovac A. Goldmann T. Vollmer E. Kayser G. (2009). AI (artificial intelligence) in histopathology—from image analysis to automated diagnosis. Folia Histochem Cytobiol 47, 355–61.
63. Keenan J. M. (2002). Value of in vitro allergy testing. Postgrad Med 111, 23; author reply 23–24.
64. Kheir J. N. Scharp L. A. Borden M. A. Swanson E. J. Loxley A. Reese J. H. Black K. J. Velazquez L. A. Thomson L. M. Walsh B. K. Mullen K. E. Graham D. A. Lawlor M. W. Brugnara C. Bell D. C. McGowan F. X. Jr (2012). Oxygen gas-filled microparticles provide intravenous oxygen delivery. Sci Transl Med 4, 140ra88.
65. Kramer J. A. Sagartz J. E. Morris D. L. (2007). The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates. Nat Rev Drug Discov 6, 636–49.
66. Krewski D. Acosta D. Jr Andersen M. Anderson H. Bailar J. C. 3rd Boekelheide K. Brent R. Charnley G. Cheung V. G. Green S. Jr Kelsey K. T. Kerkvliet N. I. Li A. A. McCray L. Meyer O. Patterson R. D. Pennie W. Scala R. A. Solomon G. M. Stephens M. Yager J. Zeise L. (2010). Toxicity testing in the 21st century: A vision and a strategy. J Toxicol Environ Health B Crit Rev 13, 51–138.
67. Krewski D. Westphal M. Al-Zoughool M. Croteau M. C. Andersen M. E. (2011). New directions in toxicity testing. Annu Rev Public Health 32, 161–78.
68. Kulpa-Eddy J. Snyder M. Stokes W. (2008). A review of trends in animal use in the United States (1972–2006). AATEX 14, 163–65.
69. Kumar D. (2011). The personalised medicine. A paradigm of evidence-based medicine. Ann Ist Super Sanita 47, 31–40.
70. Laksman Z. Detsky A. S. (2011). Personalized medicine: Understanding probabilities and managing expectations. J Gen Intern Med 26, 204–206.
71. Lazarou J. Pomeranz B. H. Corey P. N. (1998). Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 279, 1200–1205.
72. Liebsch M. Grune B. Seiler A. Butzke D. Oelgeschlager M. Pirow R. Adler S. Riebeling C. Luch A. (2011). Alternatives to animal testing: current status and future perspectives. Arch Toxicol 85, 841–58.
73. Long R. E. Smith A. Machotka S. V. Chlipala E. Cann J. Knight B. Kawano Y. Ellin J. Lowe A. (2012). Scientific and Regulatory Policy Committee (SRPC) paper: Validation of digital pathology systems in the regulated nonclinical environment. Toxicol Pathol, published online June 21, 2012. Accessed July 15, 2012. http://tpx.sagepub.com/content/early/2012/06/20/0192623312451162
74. Lumb G. Mitchell L. de la Iglesia F. A. (1985). Regression of pathologic changes induced by the long-term administration of contraceptive steroids to rodents. Toxicol Pathol 13, 283–95.
75. Mahadevan B. Snyder R. D. Waters M. D. Benz R. D. Kemper R. A. Tice R. R. Richard A. M. (2011). Genetic toxicology in the 21st century: Reflections and future directions. Environ Mol Mutagen 52, 339–54.
76. Mann P. C. Vahle J. Keenan C. M. Baker J. F. Bradley A. E. Goodman D. G. Harada T. Herbert R. Kaufmann W. Kellner R. Nolte T. Rittinghausen S. Tanaka T. (2012). International harmonization of toxicologic pathology nomenclature: An overview and review of basic principles. Toxicol Pathol 40, 7S–13S.
77. Maronpot R. R. (2011). Responsible authorship and publication practices. Toxicol Pathol 39, 1029–31.
78. May F. E. Stewart R. B. Cluff L. E. (1977). Drug interactions and multiple drug administration. Clin Pharmacol Ther 22, 322–28.
79. McCullough B. Ying X. Monticello T. Bonnefoi M. (2004). Digital microscopy imaging and new approaches in toxicologic pathology. Toxicol Pathol 32 Suppl 2, 49–58.
80. McGinnity D. F. Collington J. Austin R. P. Riley R. J. (2007). Evaluation of human pharmacokinetics, therapeutic dose and exposure predictions using marketed oral drugs. Curr Drug Metab 8, 463–79.
81. Merlot C. (2010). Computational toxicology—a tool for early safety evaluation. Drug Discov Today 15, 16–22.
82. NICEATM/ICCVAM. (n.d.). The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). Accessed July 15, 2012. http://iccvam.niehs.nih.gov/.
83. The Predictive Safety Testing Consortium. (2010). Special issue. Nat Biotechnol 28, 431–94.
84. Oberholzer M. Kehrer B. Ettlin R. A. Haroske G. Kunze K.-D. (2010). Globalisierung in der Chirurgie (Globalization in surgery). Telemedizin — ein Instrument zur weltweiten Vernetzung (Telemedicine — an instrument for worldwide consultation). Z Herz- Thorax- Gefäßchir 24, 1435–1277.
85. Offit K. (2011). Personalized medicine: new genomics, old lessons. Hum Genet 130, 3–14.
86. Olson H. Betton G. Robinson D. Thomas K. Monro A. Kolaja G. Lilly P. Sanders J. Sipes G. Bracken W. Dorato M. Van Deun K. Smith P. Berger B. Heller A. (2000). Concordance of the toxicity of pharmaceuticals in humans and in animals. Regul Toxicol Pharmacol 32, 56–67.
87. Owens L. Marzano K. Yang E. (2008). Veterinary pathologists employer demographic survey: Final report. Accessed July 15, 2012. http://www.acvp.org/Media/pdf/07employerreport.pdf
88. Ozer J. S. Dieterle F. Troth S. Perentes E. Cordier A. Verdes P. Staedtler F. Mahl A. Grenet O. Roth D. R. Wahl D. Legay F. Holder D. Erdos Z. Vlasakova K. Jin H. Yu Y. Muniappa N. Forest T. Clouse H. K. Reynolds S. Bailey W. J. Thudium D. T. Topper M. J. Skopek T. R. Sina J. F. Glaab W. E. Vonderscher J. Maurer G. Chibout S. D. Sistare F. D. Gerhold D. L. (2010). A panel of urinary biomarkers to monitor reversibility of renal injury and a serum marker with improved potential to assess renal function. Nat Biotechnol 28, 486–94.
89. Painter J. T. Clayton N. P. Herbert R. A. (2010). Useful immunohistochemical markers of tumor differentiation. Toxicol Pathol 38, 131–41.
90. Pogue D. (2012). Use it better: The worst tech predictions of all time. Accessed July 15, 2012. http://www.scientificamerican.com/article.cfm?id=pogue-all-time-worst-tech-predictions.
91. Preskorn S. H. (2001). Antipsychotic drug development in the pre-human-genome era: A full circle. J Psychiatr Pract 7, 209–13.
92. Pysz M. A. Gambhir S. S. Willmann J. K. (2010). Molecular imaging: Current status and emerging strategies. Clin Radiol 65, 500–16.
93. Quigley M. (2007). Non-human primates: The appropriate subjects of biomedical research? J Med Ethics 33, 655–58.
94. Rhomberg L. R. (2010). Toxicity testing in the 21st century: How will it affect risk assessment? J Toxicol Environ Health B Crit Rev 13, 361–75.
95. Roberts I. S. Benamore R. E. Benbow E. W. Lee S. H. Harris J. N. Jackson A. Mallett S. Patankar T. Peebles C. Roobottom C. Traill Z. C. (2012). Post-mortem imaging as an alternative to autopsy in the diagnosis of adult deaths: A validation study. Lancet 379, 136–42.
96. Routledge P. A. O'Mahony M. S. Woodhouse K. W. (2004). Adverse drug reactions in elderly patients. Br J Clin Pharmacol 57, 121–26.
97. Roy N. C. Altermann E. Park Z. A. McNabb W. C. (2011). A comparison of analog and next-generation transcriptomic tools for mammalian studies. Brief Funct Genomics 10, 135–50.
98. Ryan T. P. Stevens J. L. Thomas C. E. (2008). Strategic applications of toxicogenomics in early drug discovery. Curr Opin Pharmacol 8, 654–60.
99. Schaffner J.-C. Ernst R. Junker U. Thomas H. Germann P. G. (2009). Vascular endothelial growth factor inhibitors (VEGF inhibitors). In Classic Examples in Toxicologic Pathology (Karbe E. Drommer W. Germann P.G. Morawietz G. Kellner R., eds), 3rd ed. European Society of Toxicologic Pathology, Hannover. CD-ROM.
100. SCHER — European Commission Scientific Committees on Health and Environmental Risks. (2009). Non-human primates in research and safety testing. Accessed August 22, 2012. http://ec.europa.eu/health/opinions/en/non-human-primates/index.htm#2.
101. Schmidli H. Bretz F. Racine A. Maurer W. (2006). Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations. Biom J 48, 635–43.
102. Schwetz B. A. (2003). Toxicologic pathology: Looking ahead. Toxicol Pathol 31 Suppl, 2–5.
103. Scott S. A. (2011). Personalizing medicine with clinical pharmacogenetics. Genet Med 13, 987–95.
104. Sistare F. D. Morton D. Alden C. Christensen J. Keller D. Jonghe S. D. Storer R. D. Reddy M. V. Kraynak A. Trela B. Bienvenu J. G. Bjurstrom S. Bosmans V. Brewster D. Colman K. Dominick M. Evans J. Hailey J. R. Kinter L. Liu M. Mahrt C. Marien D. Myer J. Perry R. Potenta D. Roth A. Sherratt P. Singer T. Slim R. Soper K. Fransson-Steen R. Stoltz J. Turner O. Turnquist S. van Heerden M. Woicke J. DeGeorge J. J. (2011). An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: Support for a proposal to modify current regulatory guidelines. Toxicol Pathol 39, 716–44.
105. Smith D. Trennery P. Farningham D. Klapwijk J. (2001). The selection of marmoset monkeys (Callithrix jacchus) in pharmaceutical toxicology. Lab Anim 35, 117–30.
106. Stallard N. Todd S. (2011). Seamless phase II/III designs. Stat Methods Med Res 20, 623–34.
107. Storer R. D. Sistare F. D. Reddy M. V. DeGeorge J. J. (2010). An industry perspective on the utility of short-term carcinogenicity testing in transgenic mice in pharmaceutical development. Toxicol Pathol 38, 51–61.
108. Thomas K. Schmidt M. E. (2012). Glaxo agrees to pay $3 billion in fraud settlement. Accessed July 15, 2012. http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=1&_r=1&ref=finespenalties.
109. Tuomari D. L. Kemp R. K. Sellers R. Yarrington J. T. Geoly F. J. Fouillet X. L. Dybdal N. Perry R. (2007). Society of Toxicologic Pathology position paper on pathology image data: Compliance with 21 CFR Parts 58 and 11. Toxicol Pathol 35, 450–55.
110. Uehara T. Ono A. Maruyama T. Kato I. Yamada H. Ohno Y. Urushidani T. (2010). The Japanese toxicogenomics project: Application of toxicogenomics. Mol Nutr Food Res 54, 218–27.
111. U.S. FDA. (2006). Critical path opportunity list. Accessed July 15, 2012. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM077258.pdf.
112. U.S. FDA. (2011). Guidance for industry — Use of histology in biomarker qualification studies. Accessed August 20, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285297.pdf.
113. U.S. NAS. (2007). Toxicity testing in the 21st century: A vision and a strategy. Accessed July 15, 2012. http://dels.nas.edu/resources/static-assets/materials-based-on-reports/reports-in-brief/Toxicity_Testing_final.pdf.
114. U.S. NIH. (n.d.). ClinicalTrials.gov. Accessed July 15, 2012. http://clinicaltrials.gov/.
115. U.S. NTP. (2004). A National Toxicology Program for the 21st century — Roadmap to achieve the NTP vision. Accessed July 15, 2012. http://ntp.niehs.nih.gov/files/NTPrdmp.pdf.
116. Vahle J. Bradley A. Harada T. Herbert R. Kaufmann W. Kellner R. Mann P. Pyrah I. Rittinghausen S. Tanaka T. (2009). The international nomenclature project: An update. Toxicol Pathol 37, 694–97.
117. Vaidya V. S. Ozer J. S. Dieterle F. Collings F. B. Ramirez V. Troth S. Muniappa N. Thudium D. Gerhold D. Holder D. J. Bobadilla N. A. Marrer E. Perentes E. Cordier A. Vonderscher J. Maurer G. Goering P. L. Sistare F. D. Bonventre J. V. (2010). Kidney injury molecule-1 outperforms traditional biomarkers of kidney injury in preclinical biomarker qualification studies. Nat Biotechnol 28, 478–85.
118. van Tongeren S. Fagerland J. A. Conner M. W. Diegel K. Donnelly K. Grubor B. Lopez-Martinez A. Bolliger A. P. Sharma A. Tannehill-Gregg S. Turner P. V. Wancket L. M. (2011). The role of the toxicologic pathologist in the biopharmaceutical industry. Int J Toxicol 30, 568–82.
119. Xie L. Cianciolo R. E. Hulette B. Lee H. W. Qi Y. Cofer G. Johnson G. A. (2012). Magnetic resonance histology of age-related nephropathy in the Sprague Dawley rat. Toxicol Pathol 40, 764–78.
120. Xu J. J. Dunn M. C. Smith A. R. (2009). “Seeing is believing”: Perspectives of applying imaging technology in discovery toxicology. Comb Chem High Throughput Screen 12, 827–37.
121. Ying X. Monticello T. M. (2006). Modern imaging technologies in toxicologic pathology: An overview. Toxicol Pathol 34, 815–26.