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 submissionDiscussion of molecular targets and preclinical screeningDevelopment and validation of bioanalytical methodsChapters on clinical trial design and phase 0, I, II, III clinical trialsPharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agentsReview of the drug development process from both laboratory and clinical perspectivesNew technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development

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 submissionDiscussion of molecular targets and preclinical screeningDevelopment and validation of bioanalytical methodsChapters on clinical trial design and phase 0, I, II, III clinical trialsPharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agentsReview of the drug development process from both laboratory and clinical perspectivesNew technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development

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 submissionDiscussion of molecular targets and preclinical screeningDevelopment and validation of bioanalytical methodsChapters on clinical trial design and phase 0, I, II, III clinical trialsPharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agentsReview of the drug development process from both laboratory and clinical perspectivesNew technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development

Prostate cancer is the most common noncutaneous prostate cancer. Research has revealed several distinct malignancy and the second leading cause of cancer mechanisms of castration-resistant disease that may deaths among men in the United States. It is a critical converge in patients with disease progression on public health problem and remains incurable in the ADT. Many approaches are currently being evaluated metastatic setting with mortality that usually occurs as to improve the treatment of this condition and these a result of castration-resistant disease. fndings have identifed several potential targets for Since Huggins and Hodges’ report of the dra- therapeutic intervention. These include drugs that are matic clinical effects of suppressing serum testos- more active or less toxic chemotherapy agents; drugs terone levels in men with advanced prostate cancer that induce androgen deprivation; drugs that target in 1941, hormone therapy (also called androgen the androgen receptor and/or androgen synthesis; deprivation therapy [ADT]) has become widely drugs that target specifc pathways, including ang- accepted as the mainstay of therapy for the treat- genesis and tyrosine kinase inhibitors, endothelin ment of advanced prostate cancer. ADT combined antagonists and matrix metalloproteinase inhibitors; with radiation therapy is a standard of care in the and immunologic approaches. Many of these agents treatment of men with locally advanced prostate seem promising and the rationale and effcacy of cancer on the basis of evidence that shows improved these emerging therapies remain to be validated in survival. The role of ADT in the management of future clinical trials.

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 submissionDiscussion of molecular targets and preclinical screeningDevelopment and validation of bioanalytical methodsChapters on clinical trial design and phase 0, I, II, III clinical trialsPharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agentsReview of the drug development process from both laboratory and clinical perspectivesNew technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development

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 submissionDiscussion of molecular targets and preclinical screeningDevelopment and validation of bioanalytical methodsChapters on clinical trial design and phase 0, I, II, III clinical trialsPharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agentsReview of the drug development process from both laboratory and clinical perspectivesNew technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development

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 submissionDiscussion of molecular targets and preclinical screeningDevelopment and validation of bioanalytical methodsChapters on clinical trial design and phase 0, I, II, III clinical trialsPharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agentsReview of the drug development process from both laboratory and clinical perspectivesNew technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development

Prostate cancer is the most common noncutaneous prostate cancer. Research has revealed several distinct malignancy and the second leading cause of cancer mechanisms of castration-resistant disease that may deaths among men in the United States. It is a critical converge in patients with disease progression on public health problem and remains incurable in the ADT. Many approaches are currently being evaluated metastatic setting with mortality that usually occurs as to improve the treatment of this condition and these a result of castration-resistant disease. fndings have identifed several potential targets for Since Huggins and Hodges’ report of the dra- therapeutic intervention. These include drugs that are matic clinical effects of suppressing serum testos- more active or less toxic chemotherapy agents; drugs terone levels in men with advanced prostate cancer that induce androgen deprivation; drugs that target in 1941, hormone therapy (also called androgen the androgen receptor and/or androgen synthesis; deprivation therapy [ADT]) has become widely drugs that target specifc pathways, including ang- accepted as the mainstay of therapy for the treat- genesis and tyrosine kinase inhibitors, endothelin ment of advanced prostate cancer. ADT combined antagonists and matrix metalloproteinase inhibitors; with radiation therapy is a standard of care in the and immunologic approaches. Many of these agents treatment of men with locally advanced prostate seem promising and the rationale and effcacy of cancer on the basis of evidence that shows improved these emerging therapies remain to be validated in survival. The role of ADT in the management of future clinical trials.