Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval

Part I. In Vitro Methods. High-Volume Screening, Michel Pagé. The NCI In Vitro Anticancer Drug Discovery Screen: Concept, Implementation, and Operation, 1985-1995, 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, Fred Valeriote, Patricia LoRusso, Lisa Polin, 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, Jaqueline Plowman, Donald J. Dykes, Melinda Hollingshead, Linda Simpson-Herren, and Michael C. Alley. Fertile Seed and Rich Soil: The Development of Clinically Relevant Models of Human Cancer by Surgical Orthotopic Implantation of Intact Tissue, Robert M. Hoffman. Preclinical Models for High-Dose Therapy, Beverly A. Teicher. Models for Minimal Residual Tumor, Beverly A. Teicher. Spontaneously Occurring Tumors in Companion Animals as Models for Drug Development, David M. Vail and E. Gregory MacEwen. Part III. Clinical Testing. Working with the National Cancer Institute, Edward A. Sausville. Phase I Trial Design and Methodology, Deborah L. Toppmeyer. Phase II Clinical Trials in Oncology, Christine Khater, Paul Laub, James M. Gallo, André Rogatko, and Peter J. O'Dwyer. Drug Development in Europe, Thomas Anthony Connors and Herbert M. Pinedo. The Phase III Cancer Clinical Trial, Emil Frei III. FDA Role in Cancer Drug Development and Requirements for Approval, Robert L. Justice. Index.