Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval

Description

In this thoroughly updated and expanded second edition of Beverly Teicher's widely used classic survey, Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, leading cancer researchers from pharmaceutical companies, government laboratories, and academia provide 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. There are also new chapters on health-related quality of life (HRQL) issues in cancer clinical trials, and FDA review and requirements for approval of oncologic 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, on working with the NCI, as well as on the FDA's role in cancer drug development and in setting requirements for approval. Authoritative and up-to-date, Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval takes oncologists, pharmacologists, medicinal chemists, and other cancer researchers on an encyclopedic tour of the cancer drug development and approval process, moving from the design and execution of high-throughput screens, to preclinical testing, to safety and toxicity testing under FDA requirements, to early clinical trials, and on to final FDA approval. Front Matter....Pages i-xiv Front Matter....Pages 1-1 High-Volume Screening....Pages 3-21 High-Throughput Screening in Industry....Pages 23-39 The NCI Human Tumor Cell Line (60-Cell) Screen....Pages 41-61 Human Tumor Screening....Pages 63-76 Front Matter....Pages 77-77 Murine L1210 and P388 Leukemias....Pages 79-97 In Vivo Methods for Screening and Preclinical Testing....Pages 99-123 Human Tumor Xenograft Models in NCI Drug Development....Pages 125-152 NCI Specialized Procedures in Preclinical Drug Evaluations....Pages 153-182 Patient-Like Orthotopic Metastatic Models of Human Cancer....Pages 183-212 Preclinical Models for Combination Therapy....Pages 213-242 Models for Biomarkers and Minimal Residual Tumor....Pages 243-258 Spontaneously Occurring Tumors in Companion Animals as Models for Drug Development....Pages 259-284 Front Matter....Pages 285-285 Nonclinical Testing....Pages 287-311 Nonclinical Testing for Oncology Drug Products....Pages 313-323 Nonclinical Testing for Oncology Biologic Products....Pages 325-335 Front Matter....Pages 337-337 Working With the National Cancer Institute....Pages 339-349 Phase I Trial Design and Methodology for Anticancer Drugs....Pages 351-362 Phase II Trials....Pages 363-380 Drug Development in Europe....Pages 381-399 The Phase III Clinical Cancer Trial....Pages 401-410 Front Matter....Pages 337-337 Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials....Pages 411-419 The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products....Pages 421-427 FDA Role in Cancer Drug Development and Requirements for Approval....Pages 429-441 Back Matter....Pages 443-451