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Tytuł :
Assessment of the biochemical pathways for acetaminophen toxicity: Implications for its carcinogenic hazard potential.
Autorzy :
Jaeschke H; University of Kansas Medical Center, Department of Pharmacology, Toxicology & Therapeutics, Kansas City, KS, USA.
Murray FJ; Murray & Associates, San Jose, CA, USA.
Monnot AD; Cardno ChemRisk, San Fransisco, CA, USA.
Jacobson-Kram D; ToxRox Consulting, McLean, VA, USA.
Cohen SM; University of Nebraska Medical Center, Havlik-Wall Professor of Oncology, Department of Pathology and Microbiology, Omaha, NE, USA.
Hardisty JF; Experimental Pathology Laboratories, Inc., Research Triangle Park, NC, USA.
Atillasoy E; Johnson & Johnson Consumer Health, Fort Washington, PA, USA.
Hermanowski-Vosatka A; Johnson & Johnson Consumer Health, Fort Washington, PA, USA.
Kuffner E; Johnson & Johnson Consumer Health, Fort Washington, PA, USA.
Wikoff D; ToxStrategies, Asheville, NC, USA.
Chappell GA; ToxStrategies, Asheville, NC, USA.
Bandara SB; Cardno ChemRisk, San Fransisco, CA, USA.
Deore M; Johnson & Johnson Consumer Products, India.
Pitchaiyan SK; Johnson & Johnson Consumer Products, India.
Eichenbaum G; Johnson & Johnson, New Brunswick, NJ, USA. Electronic address: .
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2021 Mar; Vol. 120, pp. 104859. Date of Electronic Publication: 2021 Jan 01.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
A comprehensive weight of evidence assessment of published acetaminophen genotoxicity data: Implications for its carcinogenic hazard potential.
Autorzy :
Kirkland D; Kirkland Consulting, Tadcaster, LS24 0AS, UK.
Kovochich M; Cardno ChemRisk, Chicago, IL, USA.
More SL; Cardno ChemRisk, Portland, OR, USA.
Murray FJ; Murray & Associates, San Jose, CA, USA.
Monnot AD; Cardno ChemRisk, San Francisco, CA, USA.
Miller JV; Cardno ChemRisk, Pittsburgh, PA, USA.
Jaeschke H; University of Kansas Medical Center, Kansas City, KS, USA.
Jacobson-Kram D; ToxRox Consulting, McLean, VA, USA.
Deore M; Johnson & Johnson Consumer, India.
Pitchaiyan SK; Johnson & Johnson Consumer, India.
Unice K; Cardno ChemRisk, Pittsburgh, PA, USA.
Eichenbaum G; Johnson & Johnson, New Brunswick, NJ, USA. Electronic address: .
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2021 Feb 13; Vol. 122, pp. 104892. Date of Electronic Publication: 2021 Feb 13.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
A critical review of the acetaminophen preclinical carcinogenicity and tumor promotion data and their implications for its carcinogenic hazard potential.
Autorzy :
Murray FJ; Murray & Associates, San Jose, CA, USA.
Monnot AD; Cardno ChemRisk, San Francisco, CA, USA.
Jacobson-Kram D; ToxRox Consulting, McLean, VA, USA.
Cohen SM; Havlik-Wall Professor of Oncology, Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, NE, USA.
Hardisty JF; Experimental Pathology Laboratories, Inc., Durham, NC, USA.
Bandara SB; Cardno ChemRisk, San Francisco, CA, USA.
Kovochich M; Cardno ChemRisk, Chicago, IL, USA.
Deore M; Johnson & Johnson Consumer, India.
Pitchaiyan SK; Johnson & Johnson Consumer, India.
Gelotte CK; Johnson & Johnson Consumer Products, USA.
Lai JCK; Johnson & Johnson Consumer Products, USA.
Atillasoy E; Johnson & Johnson Consumer Products, USA.
Hermanowski-Vosatka A; Johnson & Johnson Consumer Products, USA.
Kuffner E; Johnson & Johnson Consumer Products, USA.
Unice KM; Cardno ChemRisk, Pittsburgh, PA, USA.
Yang K; DILIsym Services Inc., Research Triangle Park, NC, USA.
Gebremichael Y; DILIsym Services Inc., Research Triangle Park, NC, USA.
Howell BA; DILIsym Services Inc., Research Triangle Park, NC, USA.
Eichenbaum G; Johnson & Johnson, New Brunswick, NJ, USA. Electronic address: .
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2020 Dec; Vol. 118, pp. 104801. Date of Electronic Publication: 2020 Oct 09.
Typ publikacji :
Journal Article; Review
Czasopismo naukowe
Tytuł :
Application of the DILIsym® Quantitative Systems Toxicology drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen.
Autorzy :
Eichenbaum G; Johnson & Johnson, New Brunswick, NJ, 08901, USA. Electronic address: .
Yang K; DILIsym Services Inc., Research Triangle Park, NC, 27709, USA.
Gebremichael Y; DILIsym Services Inc., Research Triangle Park, NC, 27709, USA.
Howell BA; DILIsym Services Inc., Research Triangle Park, NC, 27709, USA.
Murray FJ; Murray & Associates, San Jose, CA, 95138, USA.
Jacobson-Kram D; ToxRox Consulting LLC, McLean, VA, 22101, USA.
Jaeschke H; University of Kansas Medical Center, Kansas City, KS, 66160, USA.
Kuffner E; Johnson & Johnson, New Brunswick, NJ, 08901, USA.
Gelotte CK; Johnson & Johnson Consumer Products US, Fort Washington, PA, USA.
Lai JCK; Johnson & Johnson Consumer Products US, Fort Washington, PA, USA.
Wikoff D; ToxStrategies, Inc., Asheville, NC, USA.
Atillasoy E; Johnson & Johnson Consumer Products US, Fort Washington, PA, USA.
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2020 Dec; Vol. 118, pp. 104788. Date of Electronic Publication: 2020 Oct 22.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Modernizing Human Cancer Risk Assessment of Therapeutics.
Autorzy :
Fielden MR; Amgen, One Amgen Center Drive, Thousand Oaks, CA, USA. Electronic address: .
Ward LD; Amgen, One Amgen Center Drive, Thousand Oaks, CA, USA.
Minocherhomji S; Amgen, One Amgen Center Drive, Thousand Oaks, CA, USA.
Nioi P; Amgen, One Amgen Center Drive, Thousand Oaks, CA, USA.
Lebrec H; Amgen, One Amgen Center Drive, Thousand Oaks, CA, USA.
Jacobson-Kram D; ToxRox Consulting, McLean, VA, USA.
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Źródło :
Trends in pharmacological sciences [Trends Pharmacol Sci] 2018 Mar; Vol. 39 (3), pp. 232-247. Date of Electronic Publication: 2017 Dec 11.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Pharmacovigilance*
Carcinogens/*toxicity
Drug-Related Side Effects and Adverse Reactions/*prevention & control
Neoplasms/*prevention & control
Biomarkers, Pharmacological/analysis ; Biomarkers, Tumor/genetics ; Biomarkers, Tumor/metabolism ; Genetic Predisposition to Disease ; Humans
Czasopismo naukowe
Tytuł :
Scientific and Regulatory Policy Committee (SRPC) Review: Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment.
Autorzy :
Wood CE; U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, USA .
Hukkanen RR; The Dow Chemical Company, Midland, Michigan, USA.
Sura R; The Dow Chemical Company, Midland, Michigan, USA.
Jacobson-Kram D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA Current Affiliation: NDA Partners, LLC, Rochelle, Virginia, USA.
Nolte T; Boehringer Ingelheim Pharma GmbH & Co., KG Development, Biberach an der Riss, Germany.
Odin M; Roche Diagnostics GmbH, PLBT, Penzberg, Germany.
Cohen SM; University of Nebraska Medical Center, Omaha, Nebraska, USA.
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Źródło :
Toxicologic pathology [Toxicol Pathol] 2015 Aug; Vol. 43 (6), pp. 760-75. Date of Electronic Publication: 2015 Apr 22.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Carcinogens/*toxicity
Cell Proliferation/*drug effects
Neoplasms/*diagnosis
Neoplasms/*epidemiology
Risk Assessment/*standards
Humans ; Immunohistochemistry/standards ; Quality Control ; Reference Standards ; Research Design
Czasopismo naukowe
Tytuł :
Improving prediction of carcinogenicity to reduce, refine, and replace the use of experimental animals.
Autorzy :
Bourcier T; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA. .
McGovern T; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.
Stavitskaya L; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.
Kruhlak N; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.
Jacobson-Kram D; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA; ToxRox Consulting, 5910 Chesterbrook Road, McLean, VA 22101, USA.
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Źródło :
Journal of the American Association for Laboratory Animal Science : JAALAS [J Am Assoc Lab Anim Sci] 2015 Mar; Vol. 54 (2), pp. 163-9.
Typ publikacji :
Journal Article
MeSH Terms :
Animal Experimentation*
Animals, Laboratory*
Carcinogenicity Tests*
Animal Welfare ; Animals ; Biological Assay ; Carcinogens/toxicity ; Mice ; Rats ; Species Specificity
Czasopismo naukowe
Tytuł :
Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.
Autorzy :
Sewell F; UK National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London NW1 2BE, UK. Electronic address: .
Chapman K; UK National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London NW1 2BE, UK.
Baldrick P; Covance Laboratories Ltd, Otley Road, Harrogate HG3 1PY, UK.
Brewster D; Vertex Pharmaceuticals Inc., 50 Northern Avenue, Boston, MA 02139, USA.
Broadmeadow A; Huntingdon Life Sciences Ltd, Occold, Eye, Suffolk IP23 7PX, UK.
Brown P; Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Burns-Naas LA; Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.
Clarke J; Biogen Idec, Cambridge, MA 02142, USA.
Constan A; Infinity Pharmaceuticals, 780 Memorial Drive, Cambridge, MA 02139, USA.
Couch J; Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
Czupalla O; Bayer Pharma AG, Müllerstrasse 170, 13353 Berlin, Germany.
Danks A; Charles River Laboratories, Preclinical Services, Tranent, Edinburgh EH33 2NE, UK.
DeGeorge J; Merck, 770 Sumneytown Pike, Mailstop WP45-201, West Point, PA 19486, USA.
de Haan L; MedImmune, Granta Park, Cambridge CB21 6GH, UK.
Hettinger K; Austrian Agency for Health and Food Safety, Traisengasse 5, 1200 Vienna, Austria.
Hill M; Novartis Institutes for BioMedical Research (NIBR), Basel, Switzerland.
Festag M; Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, CH - 4070 Basel, Switzerland.
Jacobs A; Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Jacobson-Kram D; Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Kopytek S; Celgene, 86 Morris Avenue, Summit, NJ 07901, USA.
Lorenz H; AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany.
Moesgaard SG; Novo Nordisk A/S, Novo Nordisk Park, Maaloev, Denmark.
Moore E; Huntingdon Life Sciences Ltd, Alconbury, Huntingdon, Cambridgeshire PE28 4HS, UK.
Pasanen M; University of Eastern Finland, Faculty of Health Sciences, School of Pharmacy, Kuopio, Finland.
Perry R; Pfizer Drug Safety Research and Development, 455 Eastern Point Rd., Groton, CT 06340, USA.
Ragan I; Board member, NC3Rs, Gibbs Building, 215 Euston Road, London NW1 2BE, UK.
Robinson S; AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.
Schmitt PM; Paul-Ehrlich-Institute, Federal Agency for Vaccines and Biomedicines, Langen, Germany.
Short B; Allergan, Drug Safety Evaluation, 2525 Dupont Dr, RD-2A, Irvine, CA 92612-1599, USA.
Lima BS; iMED, UL, University of Lisbon, Portugal.
Smith D; Millenium: The Takeda Oncology Company, 40 Landsdowne St., Cambridge, MA, USA.
Sparrow S; GlaxoSmithKline, Park Road, Ware, Hertfordshire SG12 0DP, UK.
van Bekkum Y; Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium.
Jones D; Medicines Healthcare Products Regulatory Agency (MHRA), UK.
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2014 Oct; Vol. 70 (1), pp. 413-29. Date of Electronic Publication: 2014 Jul 29.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Design*
Models, Animal*
Drug Evaluation, Preclinical/*methods
Toxicology/*methods
Animals ; Humans ; International Cooperation ; Research Design ; Surveys and Questionnaires ; Time Factors
Czasopismo naukowe

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