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National Center for Toxicological Research, US
National Center for Toxicological Research, US L Sheppard, Manchester University College of Pharmacy, Fort Wayne, IN, USA Ó 2014 Elsevier Inc. All rights reserved. This article is a revision of the previous edition article by Ankur V. Dnyanmote and Harihara M. Mehendale, volume 4, pp 541–542, Ó 2005, Elsevier Inc.
The National Center for Toxicological Research (NCTR), located in Jefferson, Arkansas, is a component of the Jefferson Laboratories of the US Food and Drug Administration (FDA). NCTR supports the mission of the FDA and the Department of Health and Human Services (DHHS) to protect and promote public health. NCTR’s mission is to promote personal and public health by conducting innovative research, providing interdisciplinary scientific expertise, participating in national and international efforts to develop standardized technologies and risk-assessment methods, and working cooperatively with scientists not only in the FDA and other government agencies but also in industry and academia, to formulate sound regulatory policies based on solid scientific foundations. Research findings of the NCTR provide the basis for FDA to make science-based risk management decisions that promote the health of the American people. NCTR has five research focus areas: (1) biomarker identification, which aims to discover and evaluate translational biomarkers of disease and toxicity, and develop alternative models for assessing efficacy and toxicity of products regulated by the FDA; (2) bio-imaging, which includes the use of electronic images as tools for pathology review and the use of PET imaging to follow the biological course of diseases at the molecular level before changes to the anatomy are apparent; (3) nanotechnology, with the goal of developing analytical tools to quantify nanomaterials in complex matrices and developing procedures for characterizing nanotechnology in products regulated by the FDA; (4) personalized medicine, which aims to improve health, reduce costs, maximize benefits, and minimize side effects of preventions and therapies based on individual factors (such as gender and lifestyle) that influence susceptibility to specific diseases or responses to particular treatments; and (5) regulatory science training, which provides hands-on laboratory training alongside experienced researchers to undergraduate and graduate students, postgraduate scientists, college and university faculty, scientists from other countries, and others. NCTR conducts translational research (i.e., interpretation and/or revision of basic scientific concepts) focused on developing a sound scientific basis for regulatory decisions and reducing the risks associated with FDA-regulated products. This research is aimed at determining the biological effects of potentially toxic chemicals or microorganisms, defining the complex mechanisms that govern their toxicity, understanding critical biological events in the expression of toxicity, and developing methods to improve assessment of human exposure, susceptibility, and risk. Customized assessment of chemicals of vital interest to the FDA involves the coordination of expertise in the areas of biochemical and molecular markers of safety and toxicity, neurotoxicology, microbiology,
Encyclopedia of Toxicology, Volume 3
chemistry, genetic or molecular toxicology, and systemsbiology assessments to identify an individual’s health status, disease risk, and susceptibility to toxicants. Using its existing strengths in methods development, statistics, analytical chemistry, and spectroscopy, NCTR is developing and standardizing new technologies such as genomics, proteomics, metabolomics, and nanotechnology in conjunction with quantitative risk assessment methods to identify early biomarkers of toxicity. NCTR is providing a foundation for better predictive toxicology through the combination of traditional toxicological data with toxicoinformatics to manage and integrate data from new technologies. Following are the NCTR’s bioinformatics tools. Specific information can be found using the following URL: http:// www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofScientific andMedicalPrograms/NCTR/default.htm 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
ArrayTrackÔ Decision Forest Endocrine Disruptor Knowledge Base (EDKB) FDALabel Gene Ontology for Functional Analysis (GOFFA) Liver Toxicity Knowledge Base (LTKB) MicroArray Quality Control (MAQC) Mold2 NCTR Liver Cancer Database (NCTRltcb) SNPTrack
NCTR shares knowledge through collaborations with scientific staff from other FDA centers representing numerous disciplines in addition to researchers at other government agencies and in industry and academia. Dissemination of research results not only to other scientists but also to the American public is a goal of NCTR’s strategic plan. To this end, NCTR staff participated in over 160 publications during fiscal year 2010, and an outreach and communications plan will inform broader audiences of the content and relevance of NCTR’s contributions. The NCTR is an FDA-owned facility that occupies a million square feet of floor space in 30 buildings on 496 acres. Laboratory and support space includes 132 general or special purpose research labs, 82 animal rooms, a nonhumanprimate research facility, a phototoxicology research center, an imaging center, and 23 specialized laboratories for pathological processing and evaluation. A BioSafety Level 3 (BSL-3) laboratory complex contains 10 individual BSL-3 laboratories. An onsite housing unit can accommodate up to 16 visiting scientists. NCTR’s online scientific journal, Regulatory Research Perspectives, highlights some of the latest research topics in the scientific regulatory arena. This publication as well as additional information about the NCTR is available on the NCTR website.
http://dx.doi.org/10.1016/B978-0-12-386454-3.00339-0
451
452
National Center for Toxicological Research, US
Contact Details
Relevant Websites
National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA. Tel.: þ1 870 543 7000. URL: http://www.fda.gov/NCTR/.
http://www.fda.gov/NCTR – National Center for Toxicological Research. http://www.fda.gov/ – U.S. Food and Drug Administration.
See also: Food and Drug Administration, US; Regulation, Toxicology and; Toxicology; Translational Toxicology.
The National Center for Toxicological Research (NCTR), located in Jefferson, Arkansas, is a component of the Jefferson Laboratories of the US Food and Drug Administration (FDA). NCTR supports the mission of the FDA and the Department of Health and Human Services (DHHS) to protect and promote public health. NCTR’s mission is to promote personal and public health by conducting innovative research, providing interdisciplinary scientific expertise, participating in national and international efforts to develop standardized technologies and risk-assessment methods, and working cooperatively with scientists not only in the FDA and other government agencies but also in industry and academia, to formulate sound regulatory policies based on solid scientific foundations. Research findings of the NCTR provide the basis for FDA to make science-based risk management decisions that promote the health of the American people. NCTR has five research focus areas: (1) biomarker identification, which aims to discover and evaluate translational biomarkers of disease and toxicity, and develop alternative models for assessing efficacy and toxicity of products regulated by the FDA; (2) bio-imaging, which includes the use of electronic images as tools for pathology review and the use of PET imaging to follow the biological course of diseases at the molecular level before changes to the anatomy are apparent; (3) nanotechnology, with the goal of developing analytical tools to quantify nanomaterials in complex matrices and developing procedures for characterizing nanotechnology in products regulated by the FDA; (4) personalized medicine, which aims to improve health, reduce costs, maximize benefits, and minimize side effects of preventions and therapies based on individual factors (such as gender and lifestyle) that influence susceptibility to specific diseases or responses to particular treatments; and (5) regulatory science training, which provides hands-on laboratory training alongside experienced researchers to undergraduate and graduate students, postgraduate scientists, college and university faculty, scientists from other countries, and others. NCTR conducts translational research (i.e., interpretation and/or revision of basic scientific concepts) focused on developing a sound scientific basis for regulatory decisions and reducing the risks associated with FDA-regulated products. This research is aimed at determining the biological effects of potentially toxic chemicals or microorganisms, defining the complex mechanisms that govern their toxicity, understanding critical biological events in the expression of toxicity, and developing methods to improve assessment of human exposure, susceptibility, and risk. Customized assessment of chemicals of vital interest to the FDA involves the coordination of expertise in the areas of biochemical and molecular markers of safety and toxicity, neurotoxicology, microbiology,
Encyclopedia of Toxicology, Volume 3
chemistry, genetic or molecular toxicology, and systemsbiology assessments to identify an individual’s health status, disease risk, and susceptibility to toxicants. Using its existing strengths in methods development, statistics, analytical chemistry, and spectroscopy, NCTR is developing and standardizing new technologies such as genomics, proteomics, metabolomics, and nanotechnology in conjunction with quantitative risk assessment methods to identify early biomarkers of toxicity. NCTR is providing a foundation for better predictive toxicology through the combination of traditional toxicological data with toxicoinformatics to manage and integrate data from new technologies. Following are the NCTR’s bioinformatics tools. Specific information can be found using the following URL: http:// www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofScientific andMedicalPrograms/NCTR/default.htm 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
ArrayTrackÔ Decision Forest Endocrine Disruptor Knowledge Base (EDKB) FDALabel Gene Ontology for Functional Analysis (GOFFA) Liver Toxicity Knowledge Base (LTKB) MicroArray Quality Control (MAQC) Mold2 NCTR Liver Cancer Database (NCTRltcb) SNPTrack
NCTR shares knowledge through collaborations with scientific staff from other FDA centers representing numerous disciplines in addition to researchers at other government agencies and in industry and academia. Dissemination of research results not only to other scientists but also to the American public is a goal of NCTR’s strategic plan. To this end, NCTR staff participated in over 160 publications during fiscal year 2010, and an outreach and communications plan will inform broader audiences of the content and relevance of NCTR’s contributions. The NCTR is an FDA-owned facility that occupies a million square feet of floor space in 30 buildings on 496 acres. Laboratory and support space includes 132 general or special purpose research labs, 82 animal rooms, a nonhumanprimate research facility, a phototoxicology research center, an imaging center, and 23 specialized laboratories for pathological processing and evaluation. A BioSafety Level 3 (BSL-3) laboratory complex contains 10 individual BSL-3 laboratories. An onsite housing unit can accommodate up to 16 visiting scientists. NCTR’s online scientific journal, Regulatory Research Perspectives, highlights some of the latest research topics in the scientific regulatory arena. This publication as well as additional information about the NCTR is available on the NCTR website.
http://dx.doi.org/10.1016/B978-0-12-386454-3.00339-0
451
452
National Center for Toxicological Research, US
Contact Details
Relevant Websites
National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA. Tel.: þ1 870 543 7000. URL: http://www.fda.gov/NCTR/.
http://www.fda.gov/NCTR – National Center for Toxicological Research. http://www.fda.gov/ – U.S. Food and Drug Administration.
See also: Food and Drug Administration, US; Regulation, Toxicology and; Toxicology; Translational Toxicology.