Anticancer drug development guide : preclinical screening, clinical trials, and approval /
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| Edition: | 2nd ed. |
|---|---|
| Imprint: | Totowa, N.J. : Humana Press, c2004. |
| Description: | xiv, 450 p. : ill. ; 26 cm. + 1 CD-ROM (4 3/4 in.). |
| Language: | English |
| Series: | Cancer drug discovery and development |
| Subject: | |
| Format: | Print Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/5128434 |
Table of Contents:
- Preface
- Contributors
- Value-Added eBook/PDA
- Part I. In Vitro Methods
- 1. High-Volume Screening
- 2. High-Throughput Screening in Industry
- 3. The NCI Human Tumor Cell Line (60-Cell) Screen: Concept, Implementation, and Applications
- 4. Human Tumor Screening
- Part II. In Vivo Methods
- 5. Murine L1210 and P388 Leukemias
- 6. In Vivo Methods for Screening and Preclinical Testing: Use of Rodent Solid Tumors for Drug Discovery
- 7. Human Tumor Xenograft Models in NCI Drug Development
- 8. NCI Specialized Procedures in Preclinical Drug Evaluations
- 9. Patient-Like Orthotopic Metastatic Models of Human Cancer
- 10. Preclinical Models for Combination Therapy
- 11. Models for Biomarkers and Minimal Residual Tumor
- 12. Spontaneously Occurring Tumors in Companion Animals As Models for Drug Development
- Part III. Nonclinical Testing to Support Human Trials
- 13. Nonclinical Testing: From Theory to Practice
- 14. Nonclinical Testing for Oncology Drug Products
- 15. Nonclinical Testing for Oncology Biologic Products
- Part IV. Clinical Testing
- 16. Working With the National Cancer Institute
- 17. Phase I Trial Design and Methodology for Anticancer Drugs
- 18. Phase II Trials: Conventional Design and Novel Strategies in the Era of Targeted Therapies
- 19. Drug Development in Europe: The Academic Perspective
- 20. The Phase III Clinical Cancer Trial
- 21. Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials: A Regulatory Perspective
- 22. The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products
- 23. FDA Role in Cancer Drug Development and Requirements for Approval
- Index
