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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 :
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
Tytuł :
Summary of major conclusions from the 5th IWGT, Basel, Switzerland, 17-19 August 2009.
Autorzy :
Kirkland DJ; Kirkland Consulting, PO Box 79, Tadcaster LS24 0AS, UK. />Hayashi M
Jacobson-Kram D
Kasper P
Gollapudi B
Müller L
Uno Y
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Źródło :
Mutation research [Mutat Res] 2011 Aug 16; Vol. 723 (2), pp. 73-6. Date of Electronic Publication: 2011 Mar 16.
Typ publikacji :
Introductory Journal Article
MeSH Terms :
Mutagenicity Tests/*methods
Mutagenicity Tests/*trends
Animals ; Humans
Czasopismo naukowe
Tytuł :
Relevance and follow-up of positive results in in vitro genetic toxicity assays: an ILSI-HESI initiative.
Autorzy :
Thybaud V; Drug Safety Evaluation, sanofi-aventis, 94400 Vitry sur Seine, France.
Aardema M
Casciano D
Dellarco V
Embry MR
Gollapudi BB
Hayashi M
Holsapple MP
Jacobson-Kram D
Kasper P
MacGregor JT
Rees R
Pokaż więcej
Źródło :
Mutation research [Mutat Res] 2007 Oct 04; Vol. 633 (2), pp. 67-79. Date of Electronic Publication: 2007 May 24.
Typ publikacji :
Congress
MeSH Terms :
Data Interpretation, Statistical*
Mutagenicity Tests*/standards
Animals ; Dose-Response Relationship, Drug ; Follow-Up Studies ; Humans ; Mutagens/pharmacokinetics ; Mutagens/toxicity ; Reproducibility of Results ; Risk Assessment
Tytuł :
Summary of major conclusions from the 4th IWGT, San Francisco, 9-10 September, 2005.
Autorzy :
Kirkland DJ; Covance Laboratories Ltd., Otley Road, Harrogate, HG3 1PY, UK. />Hayashi M
Jacobson-Kram D
Kasper P
MacGregor JT
Müller L
Uno Y
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Źródło :
Mutation research [Mutat Res] 2007 Feb 03; Vol. 627 (1), pp. 5-9. Date of Electronic Publication: 2006 Nov 29.
Typ publikacji :
Congress
MeSH Terms :
Mutagenicity Tests/*methods
Animals ; Bone Marrow Cells ; Carcinogens/classification ; Carcinogens/toxicity ; Comet Assay/methods ; Lymphoma/genetics ; Micronucleus Tests/methods ; Mutagens/toxicity ; Mutation ; Risk Assessment ; Rodentia ; Thymidine Kinase/genetics
Tytuł :
The International Workshops on Genotoxicity Testing (IWGT): history and achievements.
Autorzy :
Kirkland DJ
Hayashi M
Jacobson-Kram D
Kasper P
MacGregor JT
Müller L
Uno Y
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Źródło :
Mutation research [Mutat Res] 2007 Feb 03; Vol. 627 (1), pp. 1-4. Date of Electronic Publication: 2006 Nov 28.
Typ publikacji :
Editorial
MeSH Terms :
Mutagenicity Tests/*methods
Animals ; Congresses as Topic ; International Cooperation ; Mice ; Mutagenicity Tests/standards
Opinia redakcyjna
Tytuł :
Strategy for genotoxicity testing: hazard identification and risk assessment in relation to in vitro testing.
Autorzy :
Thybaud V; Drug Safety Evaluation, Sanofi-aventis, 94400 Vitry sur Seine, France. />Aardema M
Clements J
Dearfield K
Galloway S
Hayashi M
Jacobson-Kram D
Kirkland D
MacGregor JT
Marzin D
Ohyama W
Schuler M
Suzuki H
Zeiger E
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Corporate Authors :
Expert Working Group on Hazard Identification and Risk Assessment in Relation to In Vitro Testing
Źródło :
Mutation research [Mutat Res] 2007 Feb 03; Vol. 627 (1), pp. 41-58. Date of Electronic Publication: 2006 Nov 27.
Typ publikacji :
Journal Article
MeSH Terms :
Risk Assessment*
Mutagenicity Tests/*methods
Mutagenicity Tests/*trends
Animals ; Chromosome Aberrations ; Cytogenetic Analysis ; DNA/drug effects ; Dose-Response Relationship, Drug ; Follow-Up Studies ; Humans ; Mutagens/toxicity ; Reproducibility of Results ; Spindle Apparatus/drug effects
Czasopismo naukowe
Tytuł :
Re-evaluation of the mutagenic potential of quinacrine dihydrochloride dihydrate.
Autorzy :
Clarke JJ; Genetic Toxicology Division, BioReliance Corporation, 9630 Medical Center Drive, Rockville, MD 20850, USA. />Sokal DC
Cancel AM
Campen DB
Gudi R
Wagner VO
San RH
Jacobson-Kram D
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Źródło :
Mutation research [Mutat Res] 2001 Jul 25; Vol. 494 (1-2), pp. 41-53.
Typ publikacji :
Evaluation Study; Journal Article
MeSH Terms :
Mutagens/*toxicity
Quinacrine/*toxicity
Animals ; CHO Cells ; Chromosome Aberrations ; Cricetinae ; Dose-Response Relationship, Drug ; Female ; Male ; Mice ; Mice, Inbred ICR ; Micronucleus Tests ; Mutagenicity Tests ; Sterilization, Reproductive
Czasopismo naukowe
Tytuł :
Health effects of depleted uranium on exposed Gulf War veterans.
Autorzy :
McDiarmid MA; Department of Veterans Affairs Medical Center, Baltimore, Maryland, USA. />Keogh JP
Hooper FJ
McPhaul K
Squibb K
Kane R
DiPino R
Kabat M
Kaup B
Anderson L
Hoover D
Brown L
Hamilton M
Jacobson-Kram D
Burrows B
Walsh M
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Źródło :
Environmental research [Environ Res] 2000 Feb; Vol. 82 (2), pp. 168-80.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, Non-P.H.S.
MeSH Terms :
Veterans*
Environmental Exposure/*adverse effects
Occupational Exposure/*adverse effects
Uranium/*adverse effects
Wounds and Injuries/*complications
Adult ; Case-Control Studies ; Hematologic Tests ; Humans ; Kidney Function Tests ; Male ; Middle East ; Neurologic Examination ; Semen/chemistry ; Semen/physiology ; United States ; Uranium/urine ; Warfare ; Whole-Body Counting
Czasopismo naukowe
Tytuł :
Evaluation of potential genotoxicity of pulsed electric and electromagnetic fields used for bone growth stimulation.
Autorzy :
Jacobson-Kram D; Genetic Toxicology Division, Microbiological Associates, Inc., Rockville, MD 20850, USA. djacobson-kram@microbio.com
Tepper J
Kuo P
San RH
Curry PT
Wagner VO
Putman DL
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Źródło :
Mutation research [Mutat Res] 1997 Jan 15; Vol. 388 (1), pp. 45-57.
Typ publikacji :
Journal Article
MeSH Terms :
Chromosome Aberrations*
Electricity*
Electromagnetic Fields*
Mutagenesis*
DNA Replication/*drug effects
Liver/*metabolism
3T3 Cells ; Animals ; CHO Cells ; Cell Transformation, Neoplastic/radiation effects ; Cells, Cultured ; Cricetinae ; Escherichia coli/drug effects ; Liver/drug effects ; Male ; Mice ; Mutagenicity Tests ; Rats ; Rats, Sprague-Dawley ; Salmonella typhimurium/drug effects
Czasopismo naukowe
Tytuł :
Sister-chromatid exchange: second report of the Gene-Tox Program.
Autorzy :
Tucker JD; Biology and Biotechnology Research Program, Lawrence Livermore National Laboratory, Livermore, CA 94551.
Auletta A
Cimino MC
Dearfield KL
Jacobson-Kram D
Tice RR
Carrano AV
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Źródło :
Mutation research [Mutat Res] 1993 Sep; Vol. 297 (2), pp. 101-80.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, Non-P.H.S.; Review
MeSH Terms :
Sister Chromatid Exchange*
Mutagens/*pharmacology
Cells, Cultured ; Humans ; Mutagenicity Tests
Czasopismo naukowe
Tytuł :
Baseline and phosphoramide mustard-induced sister-chromatid exchanges in pharmacists handling anti-cancer drugs.
Autorzy :
McDiarmid MA; Johns Hopkins University, School of Hygiene and Public Health, Baltimore, MD 21205.
Kolodner K
Humphrey F
Putman D
Jacobson-Kram D
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Źródło :
Mutation research [Mutat Res] 1992 Jun 01; Vol. 279 (3), pp. 199-204.
Typ publikacji :
Journal Article
MeSH Terms :
Occupational Exposure*
Pharmacists*
Antineoplastic Agents/*adverse effects
Phosphoramide Mustards/*pharmacology
Sister Chromatid Exchange/*drug effects
Adult ; Female ; Humans ; Male
Czasopismo naukowe
Tytuł :
In vivo ionizing irradiations produce deletions in the hprt gene of human T-lymphocytes.
Autorzy :
Nicklas JA; Vermont Regional Cancer Center, Burlington.
O'Neill JP
Hunter TC
Falta MT
Lippert MJ
Jacobson-Kram D
Williams JR
Albertini RJ
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Źródło :
Mutation research [Mutat Res] 1991 Sep-Oct; Vol. 250 (1-2), pp. 383-96.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, U.S. Gov't, P.H.S.
MeSH Terms :
Chromosome Deletion*
Hypoxanthine Phosphoribosyltransferase/*radiation effects
Radioimmunotherapy/*adverse effects
T-Lymphocytes/*radiation effects
Adolescent ; Adult ; Aged ; Blotting, Southern ; Clone Cells ; DNA, Neoplasm/genetics ; DNA, Neoplasm/radiation effects ; Female ; Humans ; Hypoxanthine Phosphoribosyltransferase/genetics ; Male ; Middle Aged ; Receptors, Antigen, T-Cell/genetics ; Statistics as Topic ; T-Lymphocytes/enzymology
Czasopismo naukowe
Tytuł :
Evidence for acrolein-modified DNA in peripheral blood leukocytes of cancer patients treated with cyclophosphamide.
Autorzy :
McDiarmid MA; Johns Hopkins University, School of Hygiene and Public Health, Baltimore, MD 21205.
Iype PT
Kolodner K
Jacobson-Kram D
Strickland PT
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Źródło :
Mutation research [Mutat Res] 1991 May; Vol. 248 (1), pp. 93-9.
Typ publikacji :
Journal Article
MeSH Terms :
Acrolein/*pharmacology
Cyclophosphamide/*pharmacology
DNA/*drug effects
Neoplasms/*drug therapy
Adult ; Biomarkers, Tumor ; Dose-Response Relationship, Drug ; Enzyme-Linked Immunosorbent Assay ; Female ; Humans ; Immunoblotting ; In Vitro Techniques ; Leukocyte Count/drug effects ; Leukocytes/drug effects ; Male ; Middle Aged ; Smoking ; Time Factors
Czasopismo naukowe
Tytuł :
Baseline and phosphoramide mustard-induced sister-chromatid exchanges in cancer patients treated with cyclophosphamide.
Autorzy :
McDiarmid MA; Johns Hopkins University, School of Hygiene and Public Health, Baltimore, MD 21205.
Strickland PT
Kolodner K
Hansen J
Jacobson-Kram D
Pokaż więcej
Źródło :
Mutation research [Mutat Res] 1990 Jul; Vol. 241 (3), pp. 273-8.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
MeSH Terms :
Sister Chromatid Exchange*
Neoplasms/*drug therapy
Phosphoramide Mustards/*adverse effects
Breast Neoplasms/drug therapy ; Cells, Cultured ; Female ; Humans ; Leukemia/drug therapy ; Lymphocytes/drug effects ; Male ; Phosphoramide Mustards/therapeutic use ; Reference Values
Czasopismo naukowe
Tytuł :
Decreased in-vitro lifespan of fibroblasts derived from skin exposed to photochemotherapy in vivo.
Autorzy :
Jacobson-Kram D
Roe JL
Williams JR
Gange RW
Parrish JA
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Źródło :
Lancet (London, England) [Lancet] 1982 Dec 18; Vol. 2 (8312), pp. 1399-400.
Typ publikacji :
Letter; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
MeSH Terms :
Fibroblasts/*radiation effects
PUVA Therapy/*adverse effects
Photochemotherapy/*adverse effects
Skin Neoplasms/*etiology
Adult ; Aged ; Carcinoma, Squamous Cell/etiology ; Cell Survival ; Female ; Humans ; In Vitro Techniques ; Male ; Neoplasms, Radiation-Induced/etiology ; Skin/cytology
Raport

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