Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval - Couverture souple
Livre 2 sur 96: Cancer Drug Discovery and Development
Synopsis
Part I: In Vitro Methods High-Volume Screening Michel Pagé 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. Laurençot, 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
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