Anticancer Drug Development Guide

I. In Vitro Methods.- 1 High-Volume Screening.- 2 The NCI In Vitro Anticancer Drug Discovery Screen:Concept, Implementation, and Operation, 1985—1995.- 3 Human Tumor Screening.- II. In Vivo Methods.- 4 Murine L1210 and P388 Leukemias.- 5 In Vivo Methods for Screening and Preclinical Testing: Use of Rodent Solid Tumors for Drug Discovery.- 6 Human Tumor Xenograft Models in NCI Drug Development.- 7 Fertile Seed and Rich Soil: The Development of Clinically Relevant Models of Human Cancer by Surgical Orthotopic Implantation of Intact Tissue.- 8 Preclinical Models for High-Dose Therapy.- 9 Models for Minimal Residual Tumor.- 10 Spontaneously Occurring Tumors in Companion Animals as Models for Drug Development.- III. Clinical Testing.- 11 Working with the National Cancer Institute.- 12 Phase I Trial Design and Methodology.- 13 Phase II Clinical Trials in Oncology.- 14 Drug Development in Europe.- 15 The Phase III Cancer Clinical Trial.- 16 FD A Role in Cancer Drug Development and Requirements for Approval.