1. Molecular Targets -- 2. Preclinical Screening for New Anticancer Agents -- 3. Natural Product Screening -- 4. Defining the Starting Dose: Should it be mg/kg, mg/m2 or Fixed? -- 5. Phase 0 Trials in Oncology -- 6. Phase I Trials in Oncology - Design and Endpoints -- 7. Quantitative Analytical Methods: Development and Clinical Considerations -- 8. Validation and Control of Bioanalytical Methods -- 9. Anti-Cancer Clinical Pharmacology Overview -- 10. Pharmacokinetic Modeling -- 11. Pharmacometrics -- 12. Pharmacodynamic Modeling -- 13. Protein Binding -- 14. Metabolism (Non-CyP Enzymes) -- 15. Pharmacogenomics and Cancer Therapy: Somatic and Germline Polymorphisms -- 16. Cytochrome P450 -- 17. Polymorphisms in Genes of Drug Targets and Metabolism -- 18. DNA Repair: ERCC1, Nucleotide Excision Repair, and Platinum Resistance -- 19. Drug Interactions -- 20. ABC Transporters: Involvement in Multidrug Resistance and Drug Disposition -- 21. Solute carriers -- 22. High Throughput Platforms in Drug Metabolism and Transport Pharmacogenetics -- 23. Intrathecal Administration -- 24. Microdialysis -- 25. Regional Drug Delivery for Inoperable Pulmonary Malignancies -- 26. Blood-Brain-Barrier & CNS Malignancy -- 27. Radiation and Altering Clinical Pharmacology -- 28. Therapeutic Cancer Vaccines: An Emerging Approach to Cancer Treatment -- 29. Recombinant Immunotoxins -- 30. Monoclonal Antibodies -- 31. Clinical Pharmacology in Pediatrics -- 32. Clinical Pharmacology in the Elderly -- 33. Organ Dysfunction Trials:  Background, Historical Barriers, Progress in Overcoming Barriers and Suggestions for Future Trials -- 34. Drug Formulations: How this Affects Anticancer Drug Pharmacokinetics and Pharmacodynamics -- 35. Nanotechnology in Cancer -- 36. Imaging in Drug Development -- 37. Exposure-Response Relationship of Anticancer Agents: Application in Drug Development and Drug Label -- 38. The Role of Phase III Trials in Modern Drug Development -- 39. Clinical Trial Designs for Approval of New Anticancer Agents -- 40. Clinical Pharmacogenetics.

There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration. In this thoroughly updated and expanded second edition of the Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes of anticancer drug development, creating a single indispensable reference that covers all the steps from the identification of cancer-specific molecular targets to screening techniques and the development and validation of bioanalytical methods to clinical trial design and all phases of clinical trials. The authors have included new material on phase 0 trials in oncology, organ dysfunction trials, drug formulations and their impact on anticancer drug PK/PD including strategies to improve drug delivery, pharmacogenomics and cancer therapy, high throughput platforms in drug metabolism and transport pharmacogenetics, imaging in drug development and nanotechnology in cancer. Authoritative and up-to-date, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, 2nd Edition provides in one comprehensive and highly practical volume a detailed step-by-step guide to the successful design and approval of anticancer drugs. Road map to anticancer drug development from discovery to NDA submission Discussion of molecular targets and preclinical screening Development and validation of bioanalytical methods Chapters on clinical trial design and phase 0, I, II, III clinical trials Pharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agents Review of the drug development process from both laboratory and clinical perspectives New technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development