From Reviews of the First Edition: "...traces the critically important pathway by which a 'molecule' becomes an 'an anticancer agent'." -Unlisted Drugs "...this book is a must for all oncology fellows and junior faculty interested in drug development and will be a welcome addition on the bookshelf of all oncologists, pharmacists and other professionals interested in understanding this complex area." -Journal of Clinical Oncology

• I: In Vitro Methods.- 1 High-Volume Screening.- 2 High-Throughput Screening in Industry.- 3 The NCI Human Tumor Cell Line (60-Cell) Screen: Concept, Implementation, and Applications.- 4 Human Tumor Screening.- II: In Vivo Methods.- 5 Murine L1210 and P388 Leukemias.- 6 In Vivo Methods for Screening and Preclinical Testing: Use of Rodent Solid Tumors for Drug Discovery.- 7 Human Tumor Xenograft Models in NCI Drug Development.- 8 NCI Specialized Procedures in Preclinical Drug Evaluations.- 9 Patient-Like Orthotopic Metastatic Models of Human Cancer.- 10 Preclinical Models for Combination Therapy.- 11 Models for Biomarkers and Minimal Residual Tumor.- 12 Spontaneously Occurring Tumors in Companion Animals As Models for Drug Development.- III: Nonclinical Testing to Support Human Trials.- 13 Nonclinical Testing: From Theory to Practice.- 14 Nonclinical Testing for Oncology Drug Products.- 15 Nonclinical Testing for Oncology Biologic Products.- IV: Clinical Testing.- 16 Working With the National Cancer Institute.- 17 Phase I Trial Design and Methodology for Anticancer Drugs.- 18 Phase II Trials: Conventional Design and Novel Strategies in the Era of Targeted Therapies.- 19 Drug Development in Europe: The Academic Perspective.- 20 The Phase III Clinical Cancer Trial.- 21 Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials: A Regulatory Perspective.- 22 The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products.- 23 FDA Role in Cancer Drug Development and Requirements for Approval.

From Reviews of the First Edition: "...traces the critically important pathway by which a 'molecule' becomes an 'an anticancer agent'." -Unlisted Drugs "...this book is a must for all oncology fellows and junior faculty interested in drug development and will be a welcome addition on the bookshelf of all oncologists, pharmacists and other professionals interested in understanding this complex area." -Journal of Clinical Oncology

• I: In Vitro Methods.- 1 High-Volume Screening.- 2 High-Throughput Screening in Industry.- 3 The NCI Human Tumor Cell Line (60-Cell) Screen: Concept, Implementation, and Applications.- 4 Human Tumor Screening.- II: In Vivo Methods.- 5 Murine L1210 and P388 Leukemias.- 6 In Vivo Methods for Screening and Preclinical Testing: Use of Rodent Solid Tumors for Drug Discovery.- 7 Human Tumor Xenograft Models in NCI Drug Development.- 8 NCI Specialized Procedures in Preclinical Drug Evaluations.- 9 Patient-Like Orthotopic Metastatic Models of Human Cancer.- 10 Preclinical Models for Combination Therapy.- 11 Models for Biomarkers and Minimal Residual Tumor.- 12 Spontaneously Occurring Tumors in Companion Animals As Models for Drug Development.- III: Nonclinical Testing to Support Human Trials.- 13 Nonclinical Testing: From Theory to Practice.- 14 Nonclinical Testing for Oncology Drug Products.- 15 Nonclinical Testing for Oncology Biologic Products.- IV: Clinical Testing.- 16 Working With the National Cancer Institute.- 17 Phase I Trial Design and Methodology for Anticancer Drugs.- 18 Phase II Trials: Conventional Design and Novel Strategies in the Era of Targeted Therapies.- 19 Drug Development in Europe: The Academic Perspective.- 20 The Phase III Clinical Cancer Trial.- 21 Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials: A Regulatory Perspective.- 22 The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products.- 23 FDA Role in Cancer Drug Development and Requirements for Approval.

From Reviews of the First Edition: "...traces the critically important pathway by which a 'molecule' becomes an 'an anticancer agent'." -Unlisted Drugs "...this book is a must for all oncology fellows and junior faculty interested in drug development and will be a welcome addition on the bookshelf of all oncologists, pharmacists and other professionals interested in understanding this complex area." -Journal of Clinical Oncology

• I: In Vitro Methods.- 1 High-Volume Screening.- 2 High-Throughput Screening in Industry.- 3 The NCI Human Tumor Cell Line (60-Cell) Screen: Concept, Implementation, and Applications.- 4 Human Tumor Screening.- II: In Vivo Methods.- 5 Murine L1210 and P388 Leukemias.- 6 In Vivo Methods for Screening and Preclinical Testing: Use of Rodent Solid Tumors for Drug Discovery.- 7 Human Tumor Xenograft Models in NCI Drug Development.- 8 NCI Specialized Procedures in Preclinical Drug Evaluations.- 9 Patient-Like Orthotopic Metastatic Models of Human Cancer.- 10 Preclinical Models for Combination Therapy.- 11 Models for Biomarkers and Minimal Residual Tumor.- 12 Spontaneously Occurring Tumors in Companion Animals As Models for Drug Development.- III: Nonclinical Testing to Support Human Trials.- 13 Nonclinical Testing: From Theory to Practice.- 14 Nonclinical Testing for Oncology Drug Products.- 15 Nonclinical Testing for Oncology Biologic Products.- IV: Clinical Testing.- 16 Working With the National Cancer Institute.- 17 Phase I Trial Design and Methodology for Anticancer Drugs.- 18 Phase II Trials: Conventional Design and Novel Strategies in the Era of Targeted Therapies.- 19 Drug Development in Europe: The Academic Perspective.- 20 The Phase III Clinical Cancer Trial.- 21 Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials: A Regulatory Perspective.- 22 The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products.- 23 FDA Role in Cancer Drug Development and Requirements for Approval.