30 results on '"Leighton, John K."'
Search Results
2. An FDA Oncology Perspective of Juvenile Toxicity Studies to Support Pediatric Drug Development
3. An FDA Oncology Perspective of Juvenile Toxicity Studies to Support Pediatric Drug Development
4. An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products
5. An FDA oncology analysis of toxicities associated with PBD-containing antibody-drug conjugates
6. Workgroup Report: Review of Genomics Data Based on Experience with Mock Submissions: View of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee
7. An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection
8. An FDA oncology analysis of immune activating products and first-in-human dose selection
9. An FDA oncology analysis of antibody-drug conjugates
10. ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals: A Perspective from Regulators on the Development of the Guideline
11. FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer
12. Regulatory Aspects of Estrogens and Progestins in Human Food: Past, Present, and Future
13. FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer
14. An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs
15. Insulin-Like Growth Factors and Their Binding Proteins: Ovarian Modulators of FSH Action
16. ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals: A Perspective from Regulators on the Development of the Guideline
17. Summary of a workshop on preclinical and translational safety assessment of CD3 bispecifics
18. Pharmacogenomic data submissions to the FDA: non-clinical case studies
19. Hepatotoxicity in Oncology Drug Development
20. Tasigna for Chronic and Accelerated Phase Philadelphia Chromosome–Positive Chronic Myelogenous Leukemia Resistant to or Intolerant of Imatinib
21. Approval Summary: Azacitidine for Treatment of Myelodysplastic Syndrome Subtypes
22. Application of Emerging Technologies in Toxicology and Safety Assessment: Regulatory Perspectives
23. Center for Veterinary Medicine’s Perspective on the Beef Hormone Case
24. Expression of cytochrome P450 1A1, an estrogen hydroxylase, in ovarian granulosa cells is developmentally regulated
25. IGF-binding proteins are differentially regulated in an ovarian granulosa cell line
26. Expression of the IGF system in primary and immortalized porcine ovarian granulosa cells
27. Isolation and sequence analysis of three cloned cDNAs for rabbit liver proteins that are related to rabbit cytochrome P-450 (form 2), the major phenobarbital-inducible form
28. Characterization of rabbit cytochrome P450IIC4 cDNA and induction by phenobarbital of related hepatic mRNA levels
29. FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer.
30. FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.
Catalog
Books, media, physical & digital resources
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.