F D Sistare
Affiliation: Merck Research Laboratories
- Preclinical predictors of clinical safety: opportunities for improvementF D Sistare
Safety Assessment, Merck and Co Inc, West Point, Pennsylvania, USA
Clin Pharmacol Ther 82:210-4. 2007....
- Diagnosis of drug-induced renal tubular toxicity using global gene expression profilesYing 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...
- Towards consensus practices to qualify safety biomarkers for use in early drug developmentFrank D Sistare
Merck Research Laboratories, Safety Assessment, West Point, Pennsylvania, USA
Nat Biotechnol 28:446-54. 2010....
- An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelinesFrank 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...
- Promise of new translational safety biomarkers in drug development and challenges to regulatory qualificationFrank D Sistare
Safety Assessment and Laboratory Animal Resources, Merck and Co, Inc, West Point, PA 19486 0004, USA
Biomark Med 5:497-514. 2011....
- An evaluation of chronic 6- and 12-month rat toxicology studies as predictors of 2-year tumor outcomeM 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....
- A critical review of the effectiveness of rodent pharmaceutical carcinogenesis testing in predicting for human riskC 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...
- Transgenic tumor models for carcinogen identification: the heterozygous Trp53-deficient and RasH2 mouse linesR D Storer
Department of Genetic and Cellular Toxicology, Merck Research Laboratories, WP45 311, West Point, PA 19486, USA
Mutat Res 540:165-76. 2003....
- The utility of the K6/ODC transgenic mouse as an alternative short term dermal model for carcinogenicity testing of pharmaceuticalsT 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....