229 results on '"Jacobson-Kram, David"'
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2. Assessment of the biochemical pathways for acetaminophen toxicity: Implications for its carcinogenic hazard potential
3. Application of the DILIsym® Quantitative Systems Toxicology drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen
4. A critical review of the acetaminophen preclinical carcinogenicity and tumor promotion data and their implications for its carcinogenic hazard potential
5. History and Current Regulatory Requirements
6. Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials
7. Surveillance of Depleted Uranium Exposed Gulf War Veterans: Health Effects Observed in an Enlarged "Friendly Fire" Cohort
8. Scientific and Regulatory Policy Committee (SRPC) Review*: Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment
9. Heritable Hypersensitivity to Induced Mutagenesis in the Progeny of Cell Populations Exposed to UVC (254 nm)
10. Measurement of Chromosomal Aberrations, Sister Chromatid Exchange, hprt Mutations, and DNA Adducts in Peripheral Lymphocytes of Human Populations at Increased Risk for Cancer
11. Biological monitoring and surveillance results of Gulf War I veterans exposed to depleted uranium
12. Toxicological overview of impurities in pharmaceutical products
13. Concept and Application of Safety Thresholds in Drug Development
14. Development and Evaluation of a Genomic Signature for the Prediction and Mechanistic Assessment of Nongenotoxic Hepatocarcinogens in the Rat
15. Transgenic Animal Models in Toxicology: Historical Perspectives and Future Outlook
16. New and emerging technologies for genetic toxicity testing
17. ICH Guidelines: Inception, Revision, and Implications for Drug Development
18. Cancer Risk Assessment Approaches at the FDA/CDER: Is the Era of the 2-Year Bioassay Drawing to a Close?
19. Interlaboratory Evaluation of Genomic Signatures for Predicting Carcinogenicity in the Rat
20. Development of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal Drug Product Evaluation
21. Genetic Toxicity Assessment: Employing the Best Science for Human Safety Evaluation Part I: Early Screening for Potential Human Mutagens
22. Genetic Toxicology
23. Human Carcinogenic Risk Evaluation, Part III: Assessing Cancer Hazard and Risk in Human Drug Development
24. Challenge of Molecular Risk Assessment
25. Pharmacogenomic data submissions to the FDA: non-clinical case studies
26. Use of Transgenic Mice in Carcinogenicity Hazard Assessment
27. Distribution and toxicity resulting from adenoviral vector administration to a single salivary gland in adult rats
28. Use of Transgenic Animals for Carcinogenicity Testing: Considerations and Implications for Risk Assessment
29. Re-evaluation of the mutagenic potential of quinacrine dihydrochloride dihydrate
30. Modernizing Human Cancer Risk Assessment of Therapeutics
31. Differential and Similar Responses Between Rodent and Human Cells to DNA-Damaging Agents: Possible Implications for Cellular Aging
32. Induction of sister chromatid exchanges by inhibitors of topoisomerases
33. Comparison of the Ames assay and the induction of sister chromatid exchanges: Results with ten pharmaceuticals and five selected agents
34. Use of an established human hepatoma cell line with endogenous bioactivation for gene mutation studies
35. Effect of chronic exposure to 2,3,7,8-tetrachlorodibenzo-p-dioxin on sister chromatid exchange levels in peripheral lymphocytes of the Rhesus monkey
36. Induction of sister chromatid exchanges by benzidine in rat and human hepatoma cell lines and inhibition by indomethacin
37. Distribution and toxicity resulting from adenoviral vector administration to a single salivary gland in adult rats.
38. Methylphenidate and chromosome damage
39. New and emerging technologies for genetic toxicity testing
40. Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact
41. Towards consensus practices to qualify safety biomarkers for use in early drug development
42. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium
43. Genetic Toxicology Testing of Biopharmaceuticals
44. Cancer Risk Assessment Approaches at the FDA/CDER: Is the Era of the 2-Year Bioassay Drawing to a Close?
45. S14: Use of transgenic mice in carcinogenicity hazard assessment: Is this the future?
46. Relevance and follow-up of positive results in in vitro genetic toxicity assays: An ILSI-HESI initiative
47. Leveraging Exploratory Investigational New Drug Studies to Accelerate Drug Development
48. Genetic Toxicology Testing of Biopharmaceuticals
49. Issues in the Design and Interpretation of Chronic Toxicity and Carcinogenicity Studies in Rodents: Approaches to Dose Selection
50. Exploratory Investigational New Drug (IND) Studies in Humans
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