Part I: In Vitro Methods; High-Volume Screening Michel Page; High-Throughput Screening in Industry Michael D. Boisclair, David A. Egan, Kety Huberman, and Ralph Infantino; The NCI Human Tumor Cell Line (60-Cell) Screen: Concept, Implementation, and Applications Michael R. Boyd; Human Tumor Screening Axel-R. Hanauske, Susan G. Hilsenbeck, and Daniel D. Von Hoff; Part II: In Vivo Methods; Murine L1210 and P388 Leukemias William R. Waud; 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, and Loretta Lisow; Human Tumor Xenograft Models in NCI Drug Development Michael C. Alley, Melinda G. Hollingshead, Donald J. Dykes, and William R. Waud; NCI Specialized Procedures in Preclinical Drug Evaluations Melinda G. Hollingshead, Michael C. Alley, Gurmeet Kaur, Christine M. Pacula-Cox, and Sherman F. Stinson; Patient-Like Orthotopic Metastatic Models of Human Cancer Robert M. Hoffman; Preclinical Models for Combination Therapy Beverly A. Teicher; Models for Biomarkers and Minimal Residual Tumor Beverly A. Teicher; Spontaneously Occurring Tumors in Companion Animals As Models for Drug Development David M. Vail and Douglas H. Thamm; Part III: Nonclinical Testing to Support Human Trials; Nonclinical Testing: From Theory to Practice Denis Roy and Paul A. Andrews; Nonclinical Testing for Oncology Drug Products Paul A. Andrews and Denis Roy; Nonclinical Testing for Oncology Biologic Products Carolyn M. Laurencot, Denis Roy, and Paul A. Andrews; Part IV: Clinical Testing; Working With the National Cancer Institute Paul Thambi and Edward A. Sausville; Phase I Trial Design and Methodology for Anticancer Drugs Patrick V. Acevedo, Deborah L. Toppmeyer, and Eric H. Rubin; Phase II Trials: Conventional Design and Novel Strategies in the Era of Targeted Therapies Keith T. Flaherty and Peter J. O'Dwyer; Drug Development in Europe: The Academic Perspective Chris Twelves, Mike Bibby, Denis Lacombe, and Sally Burtles; The Phase III Clinical Cancer Trial Ramzi N. Dagher and Richard Pazdur; Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials: A Regulatory Perspective Judy H. Chiao, Grant Williams, and Donna Griebel; The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products Leslie A. Vaccari; FDA Role in Cancer Drug Development and Requirements for Approval Susan Flamm Honig; Index