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Wyświetlanie 1-8 z 8
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 :
Development and evaluation of a genomic signature for the prediction and mechanistic assessment of nongenotoxic hepatocarcinogens in the rat.
Autorzy :
Fielden MR; Comparative Biology and Safety Sciences, Amgen, South San Francisco, California 94080, USA. />Adai A
Dunn RT 2nd
Olaharski A
Searfoss G
Sina J
Aubrecht J
Boitier E
Nioi P
Auerbach S
Jacobson-Kram D
Raghavan N
Yang Y
Kincaid A
Sherlock J
Chen SJ
Car B
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Corporate Authors :
Predictive Safety Testing Consortium, Carcinogenicity Working Group
Źródło :
Toxicological sciences : an official journal of the Society of Toxicology [Toxicol Sci] 2011 Nov; Vol. 124 (1), pp. 54-74. Date of Electronic Publication: 2011 Aug 02.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Gene Expression Profiling*
Models, Genetic*
Carcinogens/*toxicity
Gene Expression Regulation, Neoplastic/*drug effects
Liver/*drug effects
Liver Neoplasms, Experimental/*chemically induced
Animals ; Carcinogens/classification ; Genetic Markers ; Genomics ; Liver/metabolism ; Liver Neoplasms, Experimental/genetics ; Male ; Predictive Value of Tests ; Rats ; Rats, Sprague-Dawley
Czasopismo naukowe
Tytuł :
Human carcinogenic risk evaluation, Part III: Assessing cancer hazard and risk in human drug development.
Autorzy :
Jacobs A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland, USA. />Jacobson-Kram D
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Źródło :
Toxicological sciences : an official journal of the Society of Toxicology [Toxicol Sci] 2004 Oct; Vol. 81 (2), pp. 260-2. Date of Electronic Publication: 2004 May 12.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug-Related Side Effects and Adverse Reactions*
Carcinogens/*toxicity
Animals ; Carcinogenicity Tests ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Drug Approval ; Humans ; Pharmacology ; Risk Assessment
Czasopismo naukowe
Tytuł :
Use of transgenic mice in carcinogenicity hazard assessment.
Autorzy :
Jacobson-Kram D; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20850, USA. />Sistare FD
Jacobs AC
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Źródło :
Toxicologic pathology [Toxicol Pathol] 2004 Mar-Apr; Vol. 32 Suppl 1, pp. 49-52.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Carcinogenicity Tests/*methods
Carcinogens/*toxicity
Neoplasms, Experimental/*chemically induced
Risk Assessment/*trends
Toxicology/*methods
Animals ; Disease Models, Animal ; Government Regulation ; Mice ; Mice, Transgenic ; Neoplasms, Experimental/genetics ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Use of transgenic animals for carcinogenicity testing: considerations and implications for risk assessment.
Autorzy :
Gulezian D; Taconic Farms, Inc, Madison, Connecticut 06443, USA.
Jacobson-Kram D
McCullough CB
Olson H
Recio L
Robinson D
Storer R
Tennant R
Ward JM
Neumann DA
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Źródło :
Toxicologic pathology [Toxicol Pathol] 2000 May-Jun; Vol. 28 (3), pp. 482-99.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Review
MeSH Terms :
Animals, Genetically Modified*
Carcinogenicity Tests/*methods
Carcinogens/*toxicity
Neoplasms, Experimental/*chemically induced
Toxicology/*methods
Animals ; Female ; Gene Targeting ; Male ; Mice ; Mice, Knockout ; Neoplasms, Experimental/genetics ; Rats ; Risk Assessment
Czasopismo naukowe
    Wyświetlanie 1-8 z 8

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