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Anticancer Drug Development Guide

Preclinical Screening, Clinical Trials, and Approval

  • Beverly A. Teicher
  • Paul A. Andrews

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

Table of contents

  1. Front Matter
    Pages i-xiv
  2. In Vitro Methods

    1. Front Matter
      Pages 1-1
    2. Michel Pagé
      Pages 3-21
    3. Michael D. Boisclair, David A. Egan, Kety Huberman, Ralph Infantino
      Pages 23-39
    4. Axel-R. Hanauske, Susan G. Hilsenbeck, Daniel D. Von Hoff
      Pages 63-76
  3. In Vivo Methods

    1. Front Matter
      Pages 77-77
    2. William R. Waud
      Pages 79-97
    3. Thomas Corbett, Lisa Polin, Patricia LoRusso, Fred Valeriote, Chiab Panchapor, Susan Pugh et al.
      Pages 99-123
    4. Michael C. Alley, Melinda G. Hollingshead, Donald J. Dykes, William R. Waud
      Pages 125-152
    5. Melinda G. Hollingshead, Michael C. Alley, Gurmeet Kaur, Christine M. Pacula-Cox, Sherman F. Stinson
      Pages 153-182
    6. Beverly A. Teicher
      Pages 213-242
    7. Beverly A. Teicher
      Pages 243-258
  4. Nonclinical Testing to Support Human Trials

    1. Front Matter
      Pages 285-285
    2. Denis Roy, Paul A. Andrews
      Pages 287-311
    3. Paul A. Andrews, Denis Roy
      Pages 313-323
    4. Carolyn M. Laurençot, Denis Roy, Paul A. Andrews
      Pages 325-335
  5. Clinical Testing

    1. Front Matter
      Pages 337-337
    2. Paul Thambi, Edward A. Sausville
      Pages 339-349
    3. Patrick V. Acevedo, Deborah L. Toppmeyer, Eric H. Rubin
      Pages 351-362
    4. Keith T. Flaherty, Peter J. O’Dwyer
      Pages 363-380
    5. Chris Twelves, Mike Bibby, Denis Lacombe, Sally Burtles
      Pages 381-399
    6. Ramzi N. Dagher, Richard Pazdur
      Pages 401-410
  6. Back Matter
    Pages 443-451

About this book

Introduction

In this thoroughly updated and expanded second edition of Beverly Teicher's widely used classic survey, Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, leading cancer researchers from pharmaceutical companies, government laboratories, and academia provide a step-by-step guide to anticancer drug development from initial design through FDA approval. The authors have included new material on the use of high-throughput screening in industry, on specialized in vitro/in vivo procedures employed by the National Cancer Institute (NCI) in preclinical drug evaluations, and on nonclinical testing to support both human clinical trials, as well as trials of biologic oncology products. There are also new chapters on health-related quality of life (HRQL) issues in cancer clinical trials, and FDA review and requirements for approval of oncologic products. The chapters on phase I, II, and III clinical trials and on novel phase II clinical trial designs for targeted therapies have been significantly updated, along with those on cancer drug development in Europe, on working with the NCI, as well as on the FDA's role in cancer drug development and in setting requirements for approval.
Authoritative and up-to-date, Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval 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, to safety and toxicity testing under FDA requirements, to early clinical trials, and on to final FDA approval.

Keywords

cancer cell clinical trial drug drug development drug discovery leukemia research screening tumor

Editors and affiliations

  • Beverly A. Teicher
    • 1
  • Paul A. Andrews
    • 2
  1. 1.Oncology Discovery and ResearchGenzyme CorporationFraminghamUSA
  2. 2.Preclinical SciencesAton Pharma Inc.TarrytownUSA

Bibliographic information