CiNii 図書 - Anticancer drug development guide : preclinical screening, clinical trials, and approval

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.

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

巻冊次: : e-book ISBN 9781592597390

内容説明

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 theraples 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.

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 Cancer Institute 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

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Anticancer drug development guide : preclinical screening, clinical trials, and approval

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