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.

"Authoritative and up-to-date...takes oncologists, pharmacologists, medicinal chemists and other cancer researchers on an encyclopedic tour of the cancer drug development and approval process, moving from the design and execution of high throughput screens, to preclinical testing under FDA requirements, to early clinical trials, and on to final FDA approval." - Tumori