Anticancer Drug Development Guide,9781588292285

Anticancer Drug Development Guide

by ;
Edition: 2nd
ISBN13: 9781588292285
ISBN10: 1588292282
Format: Hardcover
Pub. Date: 2004-02-01
Publisher(s): Humana Pr Inc
List Price: $279.99

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Summary

This thoroughly updated and expanded second edition of Beverly Teicher's widely used classic survey provides 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. 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, working with the NCI, and the FDA's role in cancer drug development and setting requirements for approval.

Table of Contents

Preface vii
Contributors xi
Value-Added eBook/PDA xiv
Part I: In Vitro Methods
1 High-Volume Screening
3(20)
Michel Pagé
2 High-Throughput Screening in Industry
23(18)
Michael D. Boisclair, David A. Egan, Kety Huberman, and Ralph Infantino
3 The NCI Human Tumor Cell Line (60-Cell) Screen: Concept, Implementation, and Applications
41(22)
Michael R. Boyd
4 Human Tumor Screening
63(16)
Axel-R. Hanauske, Susan G. Hilsenbeck, and Daniel D. Von Hoff
Part II: In Vivo Methods
5 Murine L1210 and P388 Leukemias
79(20)
William R. Waud
6 In Vivo Methods for Screening and Preclinical Testing: Use of Rodent Solid Tumors for Drug Discovery
99(26)
Thomas Corbett, Lisa Polin, Patricia LoRusso, Fred Valeriote, Chiab Panchapor, Susan Pugh, Kathryn White, Juiwanna Knight, Lisa Demchik, Julie Jones, Lynne Jones, and Loretta Lisow
7 Human Tumor Xenograft Models in NCI Drug Development
125(28)
Michael C. Alley, Melinda G. Hollingshead, Donald J. Dykes, and William R. Waud
8 NCI Specialized Procedures in Preclinical Drug Evaluations
153(30)
Melinda G. Hollingshead, Michael C. Alley, Gurmeet Kaur, Christine M. Pacula-Cox, and Sherman F. Stinson
9 Patient-Like Orthotopic Metastatic Models of Human Cancer
183(30)
Robert M. Hoffman
10 Preclinical Models for Combination Therapy
213(30)
Beverly A. Teicher
11 Models for Biomarkers and Minimal Residual Tumor
243(16)
Beverly A. Teicher
12 Spontaneously Occurring Tumors in Companion Animals As Models for Drug Development
259(28)
David M. Vail and Douglas H. Thamm
Part III: Nonclinical Testing to Support Human Trials
13 Nonclinical Testing: From Theory to Practice
287(26)
Denis Roy and Paul A. Andrews
14 Nonclinical Testing for Oncology Drug Products
313(12)
Paul A. Andrews and Denis Roy
15 Nonclinical Testing for Oncology Biologic Products
325(14)
Carolyn M. Laurencot, Denis Roy, and Paul A. Andrews
Part IV: Clinical Testing
16 Working With the National Cancer Institute
339(12)
Paul Thambi and Edward A. Sausville
17 Phase I Trial Design and Methodology for Anticancer Drugs
351(12)
Patrick V. Acevedo, Deborah L. Toppmeyer, and Eric H. Rubin
18 Phase II Trials: Conventional Design and Novel Strategies in the Era of Targeted Therapies
363(18)
Keith T. Flaherty and Peter J. O'Dwyer
19 Drug Development in Europe: The Academic Perspective
381(20)
Chris Twelves, Mike Bibby, Denis Lacombe, and Sally Burtles
20 The Phase III Clinical Cancer Trial
401(10)
Ramzi N. Dagher and Richard Pazdur
21 Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials: A Regulatory Perspective
411(10)
Judy H. Chiao, Grant Williams, and Donna Griebel
22 The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products
421(8)
Leslie A. Vaccari
23 FDA Role in Cancer Drug Development and Requirements for Approval
429(14)
Susan Flamm Honig
Index 443

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