Title | Anticancer Drug Development Guide [electronic resource] : Preclinical Screening, Clinical Trials, and Approval / edited by Beverly A. Teicher, Paul A. Andrews |
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Imprint | Totowa, NJ : Humana Press : Imprint: Humana Press, 2004 |
Edition | Second Edition |
Connect to | http://dx.doi.org/10.1007/978-1-59259-739-0 |
Descript | XIV, 451 p. 161 illus. online resource |
I: In Vitro Methods -- 1 High-Volume Screening -- 2 High-Throughput Screening in Industry -- 3 The NCI Human Tumor Cell Line (60-Cell) Screen: Concept, Implementation, and Applications -- 4 Human Tumor Screening -- II: In Vivo Methods -- 5 Murine L1210 and P388 Leukemias -- 6 In Vivo Methods for Screening and Preclinical Testing: Use of Rodent Solid Tumors for Drug Discovery -- 7 Human Tumor Xenograft Models in NCI Drug Development -- 8 NCI Specialized Procedures in Preclinical Drug Evaluations -- 9 Patient-Like Orthotopic Metastatic Models of Human Cancer -- 10 Preclinical Models for Combination Therapy -- 11 Models for Biomarkers and Minimal Residual Tumor -- 12 Spontaneously Occurring Tumors in Companion Animals As Models for Drug Development -- III: Nonclinical Testing to Support Human Trials -- 13 Nonclinical Testing: From Theory to Practice -- 14 Nonclinical Testing for Oncology Drug Products -- 15 Nonclinical Testing for Oncology Biologic Products -- IV: Clinical Testing -- 16 Working With the National Cancer Institute -- 17 Phase I Trial Design and Methodology for Anticancer Drugs -- 18 Phase II Trials: Conventional Design and Novel Strategies in the Era of Targeted Therapies -- 19 Drug Development in Europe: The Academic Perspective -- 20 The Phase III Clinical Cancer Trial -- 21 Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials: A Regulatory Perspective -- 22 The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products -- 23 FDA Role in Cancer Drug Development and Requirements for Approval