Joel P Bercu

Summary

Publications

  1. ncbi Toxicogenomics and cancer risk assessment: a framework for key event analysis and dose-response assessment for nongenotoxic carcinogens
    Joel P Bercu
    Eli Lilly and Company, Lilly Research Laboratories, Health Safety and Environmental, Indianapolis, IN 46285, USA
    Regul Toxicol Pharmacol 58:369-81. 2010
  2. ncbi Overview of genotoxic impurities in pharmaceutical development
    Joel P Bercu
    Eli Lilly and Company, Lilly Research Laboratories, Health Safety and Environmental, Indianapolis, IN 46285, USA
    Int J Toxicol 28:468-78. 2009
  3. ncbi In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances
    Joel P Bercu
    Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
    Regul Toxicol Pharmacol 57:300-6. 2010
  4. ncbi Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance
    Joel P Bercu
    Eli Lilly and Company, Lilly Research Laboratories, 2001 W Main Street, Greenfield, IN 46140, USA
    Regul Toxicol Pharmacol 51:270-7. 2008

Detail Information

Publications4

  1. ncbi Toxicogenomics and cancer risk assessment: a framework for key event analysis and dose-response assessment for nongenotoxic carcinogens
    Joel P Bercu
    Eli Lilly and Company, Lilly Research Laboratories, Health Safety and Environmental, Indianapolis, IN 46285, USA
    Regul Toxicol Pharmacol 58:369-81. 2010
    ....
  2. ncbi Overview of genotoxic impurities in pharmaceutical development
    Joel P Bercu
    Eli Lilly and Company, Lilly Research Laboratories, Health Safety and Environmental, Indianapolis, IN 46285, USA
    Int J Toxicol 28:468-78. 2009
    ..It includes recent regulatory developments such as the "staged threshold of toxicological concern" when administration is of short duration (eg, during clinical trials)...
  3. ncbi In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances
    Joel P Bercu
    Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
    Regul Toxicol Pharmacol 57:300-6. 2010
    ..This approach for non-potent compounds can be used to establish safe levels greater than the TTC for GTIs in a drug substance...
  4. ncbi Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance
    Joel P Bercu
    Eli Lilly and Company, Lilly Research Laboratories, 2001 W Main Street, Greenfield, IN 46140, USA
    Regul Toxicol Pharmacol 51:270-7. 2008
    ..Findings based on probabilistic analysis here can be very useful in making appropriate decisions about risk management of multiple genotoxic impurities measured in the final drug substance...