BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

449 related articles for article (PubMed ID: 17656486)

  • 1. Recent developments in the risk assessment of potentially genotoxic impurities in pharmaceutical drug substances.
    Humfrey CD
    Toxicol Sci; 2007 Nov; 100(1):24-8. PubMed ID: 17656486
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Overall impact of the regulatory requirements for genotoxic impurities on the drug development process.
    Giordani A; Kobel W; Gally HU
    Eur J Pharm Sci; 2011 May; 43(1-2):1-15. PubMed ID: 21420491
    [TBL] [Abstract][Full Text] [Related]  

  • 3. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity.
    Müller L; Mauthe RJ; Riley CM; Andino MM; Antonis DD; Beels C; DeGeorge J; De Knaep AG; Ellison D; Fagerland JA; Frank R; Fritschel B; Galloway S; Harpur E; Humfrey CD; Jacks AS; Jagota N; Mackinnon J; Mohan G; Ness DK; O'Donovan MR; Smith MD; Vudathala G; Yotti L
    Regul Toxicol Pharmacol; 2006 Apr; 44(3):198-211. PubMed ID: 16412543
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Overview of genotoxic impurities in pharmaceutical development.
    Bercu JP; Dobo KL; Gocke E; McGovern TJ
    Int J Toxicol; 2009; 28(6):468-78. PubMed ID: 19966139
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance.
    Bercu JP; Hoffman WP; Lee C; Ness DK
    Regul Toxicol Pharmacol; 2008 Aug; 51(3):270-7. PubMed ID: 18550240
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Improved in silico prediction of carcinogenic potency (TD50) and the risk specific dose (RSD) adjusted Threshold of Toxicological Concern (TTC) for genotoxic chemicals and pharmaceutical impurities.
    Contrera JF
    Regul Toxicol Pharmacol; 2011 Feb; 59(1):133-41. PubMed ID: 20933038
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective.
    Raman NV; Prasad AV; Ratnakar Reddy K
    J Pharm Biomed Anal; 2011 Jun; 55(4):662-7. PubMed ID: 21193280
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Guidelines and pharmacopoeial standards for pharmaceutical impurities: overview and critical assessment.
    Snodin DJ; McCrossen SD
    Regul Toxicol Pharmacol; 2012 Jul; 63(2):298-312. PubMed ID: 22507740
    [TBL] [Abstract][Full Text] [Related]  

  • 9. In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances.
    Bercu JP; Morton SM; Deahl JT; Gombar VK; Callis CM; van Lier RB
    Regul Toxicol Pharmacol; 2010; 57(2-3):300-6. PubMed ID: 20363275
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.
    EFSA GMO Panel Working Group on Animal Feeding Trials
    Food Chem Toxicol; 2008 Mar; 46 Suppl 1():S2-70. PubMed ID: 18328408
    [TBL] [Abstract][Full Text] [Related]  

  • 11. The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development.
    Dobo KL; Greene N; Cyr MO; Caron S; Ku WW
    Regul Toxicol Pharmacol; 2006 Apr; 44(3):282-93. PubMed ID: 16464524
    [TBL] [Abstract][Full Text] [Related]  

  • 12. A perspective on testing of existing pharmaceutical excipients for genotoxic impurities.
    Brusick DJ
    Regul Toxicol Pharmacol; 2009 Nov; 55(2):200-4. PubMed ID: 19607870
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Toxicological overview of impurities in pharmaceutical products.
    Jacobson-Kram D; McGovern T
    Adv Drug Deliv Rev; 2007 Jan; 59(1):38-42. PubMed ID: 17188779
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Determination of compound-specific acceptable daily intakes for 11 mutagenic carcinogens used in pharmaceutical synthesis.
    Ellis P; Kenyon M; Dobo K
    Regul Toxicol Pharmacol; 2013 Mar; 65(2):201-13. PubMed ID: 23228434
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Potentially mutagenic impurities: analysis of structural classes and carcinogenic potencies of chemical intermediates in pharmaceutical syntheses supports alternative methods to the default TTC for calculating safe levels of impurities.
    Galloway SM; Vijayaraj Reddy M; McGettigan K; Gealy R; Bercu J
    Regul Toxicol Pharmacol; 2013 Aug; 66(3):326-35. PubMed ID: 23688841
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Assessment of the genotoxic and carcinogenic risks of p-nitrophenol when it is present as an impurity in a drug product.
    Eichenbaum G; Johnson M; Kirkland D; O'Neill P; Stellar S; Bielawne J; DeWire R; Areia D; Bryant S; Weiner S; Desai-Krieger D; Guzzie-Peck P; Evans DC; Tonelli A
    Regul Toxicol Pharmacol; 2009 Oct; 55(1):33-42. PubMed ID: 19500632
    [TBL] [Abstract][Full Text] [Related]  

  • 17. The Threshold of Toxicological Concern (TTC) in risk assessment.
    Munro IC; Renwick AG; Danielewska-Nikiel B
    Toxicol Lett; 2008 Aug; 180(2):151-6. PubMed ID: 18573621
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Safety assessment of personal care products/cosmetics and their ingredients.
    Nohynek GJ; Antignac E; Re T; Toutain H
    Toxicol Appl Pharmacol; 2010 Mar; 243(2):239-59. PubMed ID: 20005888
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Principles of risk assessment for determining the safety of chemicals: recent assessment of residual solvents in drugs and di(2-ethylhexyl) phthalate.
    Hasegawa R; Koizumi M; Hirose A
    Congenit Anom (Kyoto); 2004 Jun; 44(2):51-9. PubMed ID: 15198717
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Ethyl methanesulfonate toxicity in Viracept--a comprehensive human risk assessment based on threshold data for genotoxicity.
    Müller L; Gocke E; Lavé T; Pfister T
    Toxicol Lett; 2009 Nov; 190(3):317-29. PubMed ID: 19443141
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 23.