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MORE ABOUT THIS BOOK
Main description:
This unique volume traces the critically important pathway by which a "molecule" becomes an "anticancer agent. " The recognition following World War I that the administration of toxic chemicals such as nitrogen mustards in a controlled manner could shrink malignant tumor masses for relatively substantial periods of time gave great impetus to the search for molecules that would be lethal to specific cancer cells. Weare still actively engaged in that search today. The question is how to discover these "anticancer" molecules. Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, Second Edition describes the evolution to the present of preclinical screening methods. The National Cancer Institute's high-throughput, in vitro disease-specific screen with 60 or more human tumor cell lines is used to search for molecules with novel mechanisms of action or activity against specific phenotypes. The Human Tumor Colony-Forming Assay (HTCA) uses fresh tumor biopsies as sources of cells that more nearly resemble the human disease. There is no doubt that the greatest successes of traditional chemotherapy have been in the leukemias and lymphomas. Since the earliest widely used in vivo drug screening models were the murine L 1210 and P388 leukemias, the community came to assume that these murine tumor models were appropriate to the discovery of "antileukemia" agents, but that other tumor models would be needed to discover drugs active against solid tumors.
Contents:
Part I: In Vitro Methods
High-Volume Screening
Michel Page
High-Throughput Screening in Industry
Michael D. Boisclair, David A. Egan, Kety Huberman, and Ralph Infantino
The NCI Human Tumor Cell Line (60-Cell) Screen: Concept, Implementation, and Applications
Michael R. Boyd
Human Tumor Screening
Axel-R. Hanauske, Susan G. Hilsenbeck, and Daniel D. Von Hoff
Part II: In Vivo Methods
Murine L1210 and P388 Leukemias
William R. Waud
In Vivo Methods for Screening and Preclinical Testing: Use of Rodent Solid Tumors for Drug Discovery
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
Human Tumor Xenograft Models in NCI Drug Development
Michael C. Alley, Melinda G. Hollingshead, Donald J. Dykes, and William R. Waud
NCI Specialized Procedures in Preclinical Drug Evaluations
Melinda G. Hollingshead, Michael C. Alley, Gurmeet Kaur, Christine M. Pacula-Cox, and Sherman F. Stinson
Patient-Like Orthotopic Metastatic Models of Human Cancer
Robert M. Hoffman
Preclinical Models for Combination Therapy
Beverly A. Teicher
Models for Biomarkers and Minimal Residual Tumor
Beverly A. Teicher
Spontaneously Occurring Tumors in Companion Animals As Models for Drug Development
David M. Vail and Douglas H. Thamm
Part III: Nonclinical Testing to Support Human Trials
Nonclinical Testing: From Theory to Practice
Denis Roy and Paul A. Andrews
Nonclinical Testing for Oncology Drug Products
Paul A. Andrews and Denis Roy
Nonclinical Testing for Oncology Biologic Products
Carolyn M. Laurencot, Denis Roy, and Paul A. Andrews
Part IV: Clinical Testing
Working With the National CancerInstitute
Paul Thambi and Edward A. Sausville
Phase I Trial Design and Methodology for Anticancer Drugs
Patrick V. Acevedo, Deborah L. Toppmeyer, and Eric H. Rubin
Phase II Trials: Conventional Design and Novel Strategies in the Era of Targeted Therapies
Keith T. Flaherty and Peter J. O'Dwyer
Drug Development in Europe: The Academic Perspective
Chris Twelves, Mike Bibby, Denis Lacombe, and Sally Burtles
The Phase III Clinical Cancer Trial
Ramzi N. Dagher and Richard Pazdur
Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials: A Regulatory Perspective
Judy H. Chiao, Grant Williams, and Donna Griebel
The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products
Leslie A. Vaccari
FDA Role in Cancer Drug Development and Requirements for Approval
Susan Flamm Honig
Index
PRODUCT DETAILS
Publisher: Springer (Humana Press Inc.)
Publication date: August, 2012
Pages: 451
Weight: 883g
Availability: Available
Subcategories: Oncology, Pharmacology
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