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Section 1: Chapter 1: Basic Biostatistics for the Clinical Trialist Authors: Elizabeth G. Hill and Elizabeth Garrett-Mayer Chapter 2: Fundamental Concepts in Clinical Pharmacology Authors: Daniel L. Gustafson and Erica L. Bradshaw-Pierce Chapter 3: Bioanalytical Methods in Clinical Drug Development Authors: Walter J. Loos, Peter de Bruijn, Alex Sparreboom Section 2 Chapter 1: Preclinical Models for Anticancer Drug Development Author: Edward Sausville Section 3 Chapter 1: Phase I Clinical Trials with Anticancer Agents Authors: Stephen Leong, Justin Call, Alex Adjei, Wells Messersmith Chapter 2: Phase II Clinical Trials with Anticancer Agents Authors: Hui Gan, J. Jack Lee, Lillian L. Siu Chapter 3: Phase III Clinical Trials with Anticancer Agents Authors: Wendy Parulekar and Daniel J. Sargent Chapter 4: Pharmacokinetic Studies in Early Anticancer Drug Development Authors: Sharyn D Baker and Alex Sparreboom Chapter 5: Pharmacodynamic Studies in Early Phase Drug Development Authors: D. Ross Camidge, Robert C. Doebele and Antonio Jimeno Chapter 6: Prediction of Antitumor response Authors: Yu Shyr and Fred R. Hirsch Chapter 7: Imaging Studies in Anticancer Drug Development Author: David Mankoff Section 4 Chapter 1: Role of the US Food and Drug Administration in Cancer Drug Development Authors: Ann T. Farrell, Ramzi N. Dagher and Richard Pazdur Section 5 Chapter 1: Early Clinical Trials with Cytotoxic Agents Authors: M.J.A. de Jonge and Jaap Verweij Chapter 2: Challenges and Sucesses in Developing Effective Anti-Angiogenic Agents Authors: Laura QM Chow and S Gail Eckhardt Chapter 3: Targeted Therapeutics in Cancer Treatment Authors: Colin D. Weekes and Manuel Hidalgo Chapter 4: Cancer Chemoprevention Authors: Christopher H. Lieu, William N. William Jr., Scott M. Lippman Chapter 5: Combined Modality Therapy in Cancer Management Authors: David Raben and Kyle Rusthoven Chapter 6: Cancer Vaccines Author: Dan Laheru Chapter 7: Optimizing the Development of Antibodies as Treatment for Cancer Authors: Craig P Carden, Hendrik-Tobias Arkenau and JS de Bono Chapter 8: Oligonucleotide Therapeutics Authors: Cy A Stein, Britta Hoehn, John Rossi Chapter 9: Anticancer Drug Development in Pediatric Patients Authors: Lia Gore and Margaret Macy Chapter 10: Clinical Trials in Special Populations Authors: S. Percy Ivy, MD; Merrill J. Egorin, MD; Chris H. Takimoto, MD, PhD; and Jeannette Y. Wick, RPh Section 6: Chapter 1. NCI Sponsored Clinical Trials Author: Janet E. Dancey and Andriana Papaconstantinou