Anticancer Drug Development Guide

1. Front Matter

   Pages i-xii

   PDF

2. In Vitro Methods

   1. Front Matter

      Pages 1-1

      PDF

   2. High-Volume Screening

      • Michel Pagé

      Pages 3-21

   3. The NCI In Vitro Anticancer Drug Discovery Screen

      • Michael R. Boyd

      Pages 23-42

   4. Human Tumor Screening

      • Axel-R. Hanauske, Susan G. Hilsenbeck, Daniel D. Von Hoff

      Pages 43-56

3. In Vivo Methods

   1. Front Matter

      Pages 57-57

      PDF

   2. Murine L1210 and P388 Leukemias

      • William R. Waud

      Pages 59-74

   3. In Vivo Methods for Screening and Preclinical Testing

      • Thomas Corbett, Fred Valeriote, Patricia LoRusso, Lisa Polin, Chiab Panchapor, Susan Pugh et al.

      Pages 75-99

   4. Human Tumor Xenograft Models in NCI Drug Development

      • Jacqueline Plowman, Donald J. Dykes, Melinda Hollingshead, Linda Simpson-Herren, Michael C. Alley

      Pages 101-125

   5. Fertile Seed and Rich Soil

      • Robert M. Hoffman

      Pages 127-144

   6. Preclinical Models for High-Dose Therapy

      • Beverly A. Teicher

      Pages 145-182

   7. Models for Minimal Residual Tumor

      • Beverly A. Teicher

      Pages 183-196

   8. Spontaneously Occurring Tumors in Companion Animals as Models for Drug Development

      • David M. Vail, E. Gregory MacEwen

      Pages 197-213

4. Clinical Testing

   1. Front Matter

      Pages 215-215

      PDF

   2. Working with the National Cancer Institute

      • Edward A. Sausville

      Pages 217-226

   3. Phase I Trial Design and Methodology

      • Deborah L. Toppmeyer

      Pages 227-247

   4. Phase II Clinical Trials in Oncology

      • Christine Khater, Paul Laub, James M. Gallo, André Rogatko, Peter J. O’Dwyer

      Pages 249-270

   5. Drug Development in Europe

      • Thomas Anthony Connors, Herbert M. Pinedo

      Pages 271-288

   6. The Phase III Cancer Clinical Trial

      • Emil Frei III

      Pages 289-292

   7. FDA Role in Cancer Drug Development and Requirements for Approval

      • Robert L. Justice

      Pages 293-304

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.

• cancer
• cancer research
• clinical trial
• drug
• drug development
• drug discovery
• leukemia
• methodology
• research
• screening
• tumor

"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

• Dana-Farber Cancer Institute, Boston, USA

  Beverly A. Teicher

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