323 results on '"SISTARE, FRANK D."'
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2. ICH S1 prospective evaluation study and weight of evidence assessments: commentary from industry representatives
3. Magnitude of Urine Albumin and KIM-1 Changes Can be Used to Differentiate Glomerular Injury From Tubular Injury in Rats
4. Evaluation of Urinary Renal Biomarkers for Early Prediction of Acute Kidney Injury Following Partial Nephrectomy: A Feasibility Study
5. Urine kidney safety biomarkers improve understanding of indirect intra-renal injury potential in dogs with a drug-induced prerenal azotemia
6. Kidney Safety Assessment: Current Practices in Drug Development
7. A mechanistic biomarker investigation of fialuridine hepatotoxicity using the chimeric TK-NOG Hu-liver mouse model and in vitro micropatterned hepatocyte cocultures.
8. Overview of the Application of Transcription Profiling Using Selected Nephrotoxicants for Toxicology Assessment
9. Dye-Bias Correction in Dual-Labeled cDNA Microarray Gene Expression Measurements
10. Identification of Platform-Independent Gene Expression Markers of Cisplatin Nephrotoxicity
11. Early-Onset albuminuria and Associated Renal Pathology in Leucine-Rich Repeat Kinase 2 Knockout Rats
12. Role of chronic toxicology studies in revealing new toxicities
13. Carcinogenicity Testing Strategies for Small Molecules
14. What evidence do we need for biomarker qualification?
15. Using human genetics to improve safety assessment of therapeutics
16. Novel advances in biotransformation and bioactivation research – 2020 year in review
17. A Collaborative Initiative to Establish Genomic Biomarkers for Assessing Tumorigenic Potential to Reduce Reliance on Conventional Rodent Carcinogenicity Studies
18. Universal Accessible Biomarkers of Drug-Induced Tissue Injury and Systemic Inflammation in Rat: Performance Assessment of TIMP-1, A2M, AGP, NGAL, and Albumin
19. Survey of tumorigenic sensitivity in 6-month rasH2-Tg mice studies compared with 2-year rodent assays
20. Kidney Injury Monitoring in Tobramycin-Treated Rhesus Monkeys: Supplementing Urinary Kidney Biomarkers With Kidney Biopsy Gene Expression Profiling
21. Regulatory Forum Commentary* Counterpoint: Dose Selection for Tg.rasH2 Mouse Carcinogenicity Studies
22. Supplemental Material, sj-docx-1-tpx-10.1177_01926233211049171 - Kidney Injury Monitoring in Tobramycin-Treated Rhesus Monkeys: Supplementing Urinary Kidney Biomarkers With Kidney Biopsy Gene Expression Profiling
23. Collaborative Initiative to Establish Genomic Biomarkers for Assessing Tumorigenic Potential to Reduce Reliance on Conventional Rodent Carcinogenicity Studies.
24. Universal Toxicity Gene Signatures for Early Identification of Drug-Induced Tissue Injuries in Rats
25. Early alterations in heart gene expression profiles associated with doxorubicin cardiotoxicity in rats
26. Regulatory Forum Commentary*: Alternative Mouse Models for Future Cancer Risk Assessment
27. Evaluation of the Relative Performance of 12 Urinary Biomarkers for Renal Safety Across 22 Rat Sensitivity and Specificity Studies
28. Supplemental Material, sj-docx-1-tpx-10.1177_0192623320932159 - Evaluation of 10 Urinary Biomarkers for Renal Safety With 5 Nephrotoxicants in Nonhuman Primates
29. A Performance Evaluation of Three Drug-Induced Liver Injury Biomarkers in the Rat: Alpha-Glutathione S-Transferase, Arginase 1, and 4-Hydroxyphenyl-Pyruvate Dioxygenase
30. Kidney Injury Monitoring in Tobramycin-Treated Rhesus Monkeys: Supplementing Urinary Kidney Biomarkers With Kidney Biopsy Gene Expression Profiling.
31. Applications of Toxicogenomics to Nonclinical Drug Development: Regulatory Science Considerations
32. Promise of new translational safety biomarkers in drug development and challenges to regulatory qualification
33. An Analysis of Pharmaceutical Experience with Decades of Rat Carcinogenicity Testing: Support for a Proposal to Modify Current Regulatory Guidelines
34. A Two-Tiered In Vitro Approach to De-Risk Drug Candidates for Potential Bile Salt Export Pump Inhibition Liabilities in Drug Discovery
35. Evaluation of 10 Urinary Biomarkers for Renal Safety With 5 Nephrotoxicants in Nonhuman Primates
36. Mechanistic Investigations Support Liver Safety of Ubrogepant
37. Development and Application of a Transcriptomic Signature of Bioactivation in an Advanced In Vitro Liver Model to Reduce Drug-induced Liver Injury Risk Early in the Pharmaceutical Pipeline
38. Application of a Rat Liver Drug Bioactivation Transcriptional Response Assay Early in Drug Development That Informs Chemically Reactive Metabolite Formation and Potential for Drug-induced Liver Injury
39. Tg.rasH2 Mouse Model for Assessing Carcinogenic Potential of Pharmaceuticals: Industry Survey of Current Practices
40. Qualification of Safety Biomarkers for Application to Early Drug Development
41. Quantitative Transcriptional Biomarkers of Xenobiotic Receptor Activation in Rat Liver for the Early Assessment of Drug Safety Liabilities
42. An Industry Perspective on the Utility of Short-Term Carcinogenicity Testing in Transgenic Mice in Pharmaceutical Development
43. Histopathology of Vascular Injury in Sprague-Dawley Rats Treated with Phosphodiesterase IV Inhibitor SCH 351591 or SCH 534385
44. Biomarkers in Peripheral Blood Associated with Vascular Injury in Sprague-Dawley Rats Treated with the Phosphodiesterase IV Inhibitors SCH 351591 or SCH 534385
45. Mechanisms and Biomarkers of Cardiovascular Injury Induced by Phosphodiesterase Inhibitor III SK&F 95654 in the Spontaneously Hypertensive Rat
46. Use of a mixed tissue RNA design for performance assessments on multiple microarray formats
47. The Utility of Genetically Modified Mouse Assays for Identifying Human Carcinogens: A Basic Understanding and Path Forward
48. Toxicoproteomics: Serum Proteomic Pattern Diagnostics for Early Detection of Drug Induced Cardiac Toxicities and Cardioprotection
49. Use of Transgenic Mice in Carcinogenicity Hazard Assessment
50. Evaluation of the Tg.AC Assay: Specificity Testing with Three Noncarcinogenic Pharmaceuticals that Induce Selected Stress Gene Promoters in Vitro and the Inhibitory Effects of Solvent Components
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