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Anticancer Drug Development Guide

Preclinical Screening, Clinical Trials, and Approval

  • Book
  • © 1997

Overview

Editors:
  1. Beverly A. Teicher

    1. Dana-Farber Cancer Institute, Boston, USA

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    You can also search for this editor in PubMed   Google Scholar

Part of the book series: Cancer Drug Discovery and Development (CDD&D)

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Table of contents (16 chapters)

  1. Front Matter

    Pages i-xii
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  2. In Vitro Methods

    1. Front Matter

      Pages 1-1
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    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
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    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
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    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
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Keywords

About this book

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.

Reviews

"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

Editors and Affiliations

  • Dana-Farber Cancer Institute, Boston, USA

    Beverly A. Teicher

Bibliographic Information

  • Book Title: Anticancer Drug Development Guide

  • Book Subtitle: Preclinical Screening, Clinical Trials, and Approval

  • Editors: Beverly A. Teicher

  • Series Title: Cancer Drug Discovery and Development

  • DOI: https://doi.org/10.1007/978-1-4615-8152-9

  • Publisher: Humana Totowa, NJ

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer Science+Business Media New York 1997

  • Softcover ISBN: 978-1-4615-8154-3Published: 25 June 2013

  • eBook ISBN: 978-1-4615-8152-9Published: 11 November 2013

  • Series ISSN: 2196-9906

  • Series E-ISSN: 2196-9914

  • Edition Number: 1

  • Number of Pages: XII, 311

  • Number of Illustrations: 39 b/w illustrations

  • Topics: Pharmacology/Toxicology, Oncology

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