Principles of Anticancer Drug Development

Front Matter....Pages i-xvii
Front Matter....Pages 1-1
Basic Biostatistics for the Clinical Trialist....Pages 3-35
Fundamental Concepts in Clinical Pharmacology....Pages 37-62
Bioanalytical Methods in Clinical Drug Development....Pages 63-86
Front Matter....Pages 87-87
Preclinical Models for Anticancer Drug Development....Pages 89-114
Front Matter....Pages 115-115
Phase I Clinical Trials with Anticancer Agents....Pages 117-139
Phase II Trials with Anticancer Agents....Pages 141-161
Phase III Clinical Trials with Anticancer Agents....Pages 163-188
Pharmacokinetic Studies in Early Anticancer Drug Development....Pages 189-214
Pharmacodynamic Studies in Early Phase Drug Development....Pages 215-256
Prediction of Antitumor Response....Pages 257-274
Imaging Studies in Anticancer Drug Development....Pages 275-302
Front Matter....Pages 303-303
Role of the US Food and Drug Administration in Cancer Drug Development....Pages 305-332
Front Matter....Pages 333-333
Early Clinical Trials with Cytotoxic Agents....Pages 335-345
Challenges and Successes in Developing Effective Anti-angiogenic Agents....Pages 347-401
Targeted Therapeutics in Cancer Treatment....Pages 403-461
Cancer Chemoprevention....Pages 463-481
Combined Modality Therapy in Cancer Management....Pages 483-517
Cancer Vaccines....Pages 519-533
Optimising the Development of Antibodies as Treatment for Cancer....Pages 535-567
Oligonucleotide Therapeutics....Pages 569-587
Front Matter....Pages 333-333
Anticancer Drug Development in Pediatric Patients....Pages 589-601
Clinical Trials in Special Populations....Pages 603-628
Front Matter....Pages 629-629
NCI-Sponsored Clinical Trials....Pages 631-657
Back Matter....Pages 659-673