Principles of Anticancer Drug Development

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Summary

A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.


Basic Biosatistics for the Clinical Trialist	p. 3
Fundamental Concepts in Clinical Pharmacology	p. 37
Bioanalytical Methods in Clinical Drug Development	p. 63

Preclinical Models for Anticancer Drug Development	p. 89

Phase I Clinical Trials with Anticancer Agents	p. 117
Phase II Trials with Anticancer Agents	p. 141
Phase III Clinical Trials with Anticancer Agents	p. 163
Pharmacokinetic Studies in Early Anticancer Drug Development	p. 189
Pharmacodynamic Studies in Early Phase Drug Development	p. 215
Prediction of Antitumor Response	p. 257
Imaging Studies in Anticancer Drug Development	p. 275
Role of the US Food and Drug Administration in Cancer Drug Development	p. 305

Early Clinical Trials with Cytotoxic Agents	p. 335
Challenges and Saccesses in Developing Effective Anti-angiogenic Agents	p. 347
Targeted Therapeutics in Cancer Treatment	p. 403
Cancer Chemoprevention	p. 463
Combined Modality Therapy in Cancer Management	p. 483
Cancer Vaccines	p. 519
Optimising the Development of Antibodies as Treatment for Cancer	p. 535
Oligonucleotide Therapeutics	p. 569
Anticancer Drug Development in Pediatric Patients	p. 589
Clinical Trials in Special Populations	p. 603

NCI-Sponsored Clinical Trials	p. 631
Index	p. 659
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