F D Sistare

Summary

Affiliation: Merck Research Laboratories
Country: USA

Publications

  1. ncbi request reprint Preclinical predictors of clinical safety: opportunities for improvement
    F D Sistare
    Safety Assessment, Merck and Co Inc, West Point, Pennsylvania, USA
    Clin Pharmacol Ther 82:210-4. 2007
  2. pmc Diagnosis of drug-induced renal tubular toxicity using global gene expression profiles
    Ying Jiang
    Safety Assessment, Merck Research Laboratories, Merck and Co, Inc, 770 Sumneytown Pike, West Point, PA 19486, USA
    J Transl Med 5:47. 2007
  3. doi request reprint Towards consensus practices to qualify safety biomarkers for use in early drug development
    Frank D Sistare
    Merck Research Laboratories, Safety Assessment, West Point, Pennsylvania, USA
    Nat Biotechnol 28:446-54. 2010
  4. doi request reprint An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines
    Frank D Sistare
    Merck and Co, Inc, West Point, Pennsylvania 19486 0004, USA
    Toxicol Pathol 39:716-44. 2011
  5. doi request reprint Promise of new translational safety biomarkers in drug development and challenges to regulatory qualification
    Frank D Sistare
    Safety Assessment and Laboratory Animal Resources, Merck and Co, Inc, West Point, PA 19486 0004, USA
    Biomark Med 5:497-514. 2011
  6. doi request reprint An evaluation of chronic 6- and 12-month rat toxicology studies as predictors of 2-year tumor outcome
    M V Reddy
    Safety Assessment, Merck and Co, Inc, WP 45 201, 770 Sumneytown Pike, West Point, PA 19486 0004, USA
    Vet Pathol 47:614-29. 2010
  7. doi request reprint A critical review of the effectiveness of rodent pharmaceutical carcinogenesis testing in predicting for human risk
    C L Alden
    Millennium Pharmaceuticals, Inc, Cambridge, MA, USA
    Vet Pathol 48:772-84. 2011
  8. ncbi request reprint Transgenic tumor models for carcinogen identification: the heterozygous Trp53-deficient and RasH2 mouse lines
    R D Storer
    Department of Genetic and Cellular Toxicology, Merck Research Laboratories, WP45 311, West Point, PA 19486, USA
    Mutat Res 540:165-76. 2003
  9. ncbi request reprint The utility of the K6/ODC transgenic mouse as an alternative short term dermal model for carcinogenicity testing of pharmaceuticals
    T J Miller
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Regul Toxicol Pharmacol 50:87-97. 2008

Detail Information

Publications9

  1. ncbi request reprint Preclinical predictors of clinical safety: opportunities for improvement
    F D Sistare
    Safety Assessment, Merck and Co Inc, West Point, Pennsylvania, USA
    Clin Pharmacol Ther 82:210-4. 2007
    ....
  2. pmc Diagnosis of drug-induced renal tubular toxicity using global gene expression profiles
    Ying Jiang
    Safety Assessment, Merck Research Laboratories, Merck and Co, Inc, 770 Sumneytown Pike, West Point, PA 19486, USA
    J Transl Med 5:47. 2007
    ..We achieved a Sn (sensitivity) = 88% and a Sp (specificity) = 91%. The diagnosis performance underscores the potential application of toxicogenomics in a preclinical lead optimization process of drugs entering into development...
  3. doi request reprint Towards consensus practices to qualify safety biomarkers for use in early drug development
    Frank D Sistare
    Merck Research Laboratories, Safety Assessment, West Point, Pennsylvania, USA
    Nat Biotechnol 28:446-54. 2010
    ....
  4. doi request reprint An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines
    Frank D Sistare
    Merck and Co, Inc, West Point, Pennsylvania 19486 0004, USA
    Toxicol Pathol 39:716-44. 2011
    ..This proposed decision paradigm has the potential to eliminate over 40% of rat two-year testing on new pharmaceuticals without compromise to patient safety...
  5. doi request reprint Promise of new translational safety biomarkers in drug development and challenges to regulatory qualification
    Frank D Sistare
    Safety Assessment and Laboratory Animal Resources, Merck and Co, Inc, West Point, PA 19486 0004, USA
    Biomark Med 5:497-514. 2011
    ....
  6. doi request reprint An evaluation of chronic 6- and 12-month rat toxicology studies as predictors of 2-year tumor outcome
    M V Reddy
    Safety Assessment, Merck and Co, Inc, WP 45 201, 770 Sumneytown Pike, West Point, PA 19486 0004, USA
    Vet Pathol 47:614-29. 2010
    ....
  7. doi request reprint A critical review of the effectiveness of rodent pharmaceutical carcinogenesis testing in predicting for human risk
    C L Alden
    Millennium Pharmaceuticals, Inc, Cambridge, MA, USA
    Vet Pathol 48:772-84. 2011
    ..Significant opportunities exist for improving the effectiveness and efficiency of the current cancer risk assessment paradigm...
  8. ncbi request reprint Transgenic tumor models for carcinogen identification: the heterozygous Trp53-deficient and RasH2 mouse lines
    R D Storer
    Department of Genetic and Cellular Toxicology, Merck Research Laboratories, WP45 311, West Point, PA 19486, USA
    Mutat Res 540:165-76. 2003
    ....
  9. ncbi request reprint The utility of the K6/ODC transgenic mouse as an alternative short term dermal model for carcinogenicity testing of pharmaceuticals
    T J Miller
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Regul Toxicol Pharmacol 50:87-97. 2008
    ....