1. High-Volume Screening
Michel Pagé
pp. 3-22
2. High-Throughput Screening in Industry
Michael Boisclair; David Egan; Kety Huberman; Ralph Infantino
pp. 23-40
3. The NCI Human Tumor Cell Line (60-Cell) Screen: Concept, Implementation, and Applications
Michael Boyd
pp. 41-62
4. Human Tumor Screening
Axel-R. Hanauske; Susan Hilsenbeck; Daniel Von Hoff
pp. 63-76
5. Murine L1210 and P388 Leukemias
William Waud
pp. 79-98
6. In Vivo Methods for Screening and Preclinical Testing: Use of Rodent Solid Tumors for Drug Discovery
Thomas Corbett; Lisa Polin; Patricia LoRusso; Fred Valeriote; Chiab Panchapor; Susan Pugh; Kathryn White; Juiwanna Knight; Lisa Demchik; Julie Jones; Lynne Jones; Loretta Lisow
pp. 99-124
7. Human Tumor Xenograft Models in NCI Drug Development
Michael Alley; Melinda Hollingshead; Donald Dykes; William Waud
pp. 125-152
8. NCI Specialized Procedures in Preclinical Drug Evaluations
Melinda Hollingshead; Michael Alley; Gurmeet Kaur; Christine Pacula-Cox; Sherman Stinson
pp. 153-182
9. Patient-Like Orthotopic Metastatic Models of Human Cancer
Robert Hoffman
pp. 183-212
10. Preclinical Models for Combination Therapy
Beverly Teicher
pp. 213-242
11. Models for Biomarkers and Minimal Residual Tumor
Tumor Teicher
pp. 243-258
12. Spontaneously Occurring Tumors in Companion Animals As Models for Drug Development
David Vail; Douglas Thamm
pp. 259-284
13. Nonclinical Testing: From Theory to Practice
Denis Roy; Paul Andrews
pp. 287-312
14. Nonclinical Testing for Oncology Drug Products
Paul Andrews; Denis Roy
pp. 313-324
15. Nonclinical Testing for Oncology Biologic Products
Carolyn Laurençot; Denis Roy; Paul Andrews
pp. 325-336
16. Working With the National Cancer Institute
Paul Thambi; Edward Sausville
pp. 339-350
17. Phase I Trial Design and Methodology for Anticancer Drugs
Patrick Acevedo; Deborah Toppmeyer; Eric Rubin
pp. 351-362
18. Phase II Trials: Conventional Design and Novel Strategies in the Era of Targeted Therapies
Keith Flaherty; Peter O'Dwyer
pp. 363-380
19. Drug Development in Europe: The Academic Perspective
Chris Twelves; Mike Bibby; Denis Lacombe; Sally Burtles
pp. 381-400
20. The Phase III Clinical Cancer Trial
Ramzi Dagher; Richard Pazdur
pp. 401-410
21. Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials: A Regulatory Perspective
Judy Chiao; Grant Williams; Donna Griebel
pp. 411-420
22. The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products
Leslie Vaccari
pp. 421-428
23. FDA Role in Cancer Drug Development and Requirements for Approval
Susan Honig
pp. 429-442
Abstract:
This thoroughly updated and expanded second edition of Beverly Teicher's widely used classic survey provides a step-by-step guide to anticancer drug development from initial design through FDA approval. The authors have included new material on the use of high throughput screening in industry, on specialized in vitro/in vivo procedures employed by the National Cancer Institute (NCI) in preclinical drug evaluations, and on nonclinical testing to support both human clinical trials, as well as trials of biologic oncology products. The chapters on phase I, II, and III clinical trials and on novel phase II clinical trial designs for targeted therapies have been significantly updated, along with those on cancer drug development in Europe, working with the NCI, and the FDA's role in cancer drug development and setting requirements for approval.