Experienced cancer researchers from pharmaceutical companies, government laboratories, and academia comprehensively review and describe the arduous process of cancer drug discovery and approval. They focus on using preclinical in vivo and in vitro methods to identify molecules of interest, detailing the targets and criteria for success in each type of testing and defining the value of the information obtained from the various tests. They also define each stage of clinical testing, explain the criteria for success, and outline the requirements for FDA approval. A companion volume by the same editor (Cancer Therapeutics: Experimental and Clinical Agents) reviews existing anticancer drugs and potential anticancer therapies. These two volumes in the Cancer Drug Discovery and Development series reveal how and why molecules become anticancer drugs and thus offer a blueprint for the present and the future of the field.

Inhalt
I. In Vitro Methods.- 1 High-Volume Screening.- 2 The NCI In Vitro Anticancer Drug Discovery Screen:Concept, Implementation, and Operation, 19851995.- 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.