Contents · Walter J. Loos, Peter de Bruijn, and Alex Sparreboom Part II 4 Preclinical Models for...
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ix Contents Part I 1 Basic Biostatistics for the Clinical Trialist ............................................ 3 Elizabeth G. Hill and Elizabeth Garrett-Mayer 2 Fundamental Concepts in Clinical Pharmacology............................... 37 Daniel L. Gustafson and Erica L. Bradshaw-Pierce 3 Bioanalytical Methods in Clinical Drug Development ........................ 63 Walter J. Loos, Peter de Bruijn, and Alex Sparreboom Part II 4 Preclinical Models for Anticancer Drug Development ........................ 89 Edward A. Sausville Part III 5 Phase I Clinical Trials with Anticancer Agents.................................... 117 Stephen Leong, Justin Call, Alex Adjei, and Wells Messersmith 6 Phase II Trials with Anticancer Agents ................................................ 141 Hui K. Gan, J. Jack Lee, and Lillian L. Siu 7 Phase III Clinical Trials with Anticancer Agents ................................ 163 Wendy R. Parulekar and Daniel J. Sargent 8 Pharmacokinetic Studies in Early Anticancer Drug Development .................................................................................. 189 Alex Sparreboom and Sharyn D. Baker 9 Pharmacodynamic Studies in Early Phase Drug Development .......... 215 D. Ross Camidge, Robert C. Doebele, and Antonio Jimeno 10 Prediction of Antitumor Response ........................................................ 257 Fred R. Hirsch and Yu Shyr 11 Imaging Studies in Anticancer Drug Development ............................. 275 David A. Mankoff
Transcript of Contents · Walter J. Loos, Peter de Bruijn, and Alex Sparreboom Part II 4 Preclinical Models for...
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Contents
Part I
1 Basic Biostatistics for the Clinical Trialist ............................................ 3Elizabeth G. Hill and Elizabeth Garrett-Mayer
2 Fundamental Concepts in Clinical Pharmacology............................... 37Daniel L. Gustafson and Erica L. Bradshaw-Pierce
3 Bioanalytical Methods in Clinical Drug Development ........................ 63Walter J. Loos, Peter de Bruijn, and Alex Sparreboom
Part II
4 Preclinical Models for Anticancer Drug Development ........................ 89Edward A. Sausville
Part III
5 Phase I Clinical Trials with Anticancer Agents.................................... 117Stephen Leong, Justin Call, Alex Adjei, and Wells Messersmith
6 Phase II Trials with Anticancer Agents ................................................ 141Hui K. Gan, J. Jack Lee, and Lillian L. Siu
7 Phase III Clinical Trials with Anticancer Agents ................................ 163Wendy R. Parulekar and Daniel J. Sargent
8 Pharmacokinetic Studies in Early Anticancer Drug Development .................................................................................. 189Alex Sparreboom and Sharyn D. Baker
9 Pharmacodynamic Studies in Early Phase Drug Development .......... 215D. Ross Camidge, Robert C. Doebele, and Antonio Jimeno
10 Prediction of Antitumor Response ........................................................ 257Fred R. Hirsch and Yu Shyr
11 Imaging Studies in Anticancer Drug Development ............................. 275David A. Mankoff
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Part IV
12 Role of the US Food and Drug Administration in Cancer Drug Development................................................................. 305Ann T. Farrell, Ramzi N. Dagher, and Richard Pazdur
Part V
13 Early Clinical Trials with Cytotoxic Agents ......................................... 335M.J.A. de Jonge and Jaap Verweij
14 Challenges and Successes in Developing Effective Anti-angiogenic Agents ........................................................................... 347Laura Q.M. Chow and S. Gail Eckhardt
15 Targeted Therapeutics in Cancer Treatment ....................................... 403Colin D. Weekes and Manuel Hidalgo
16 Cancer Chemoprevention ....................................................................... 463Christopher H. Lieu, William N. William Jr, and Scott M. Lippman
17 Combined Modality Therapy in Cancer Management ....................... 483David Raben and Kyle Rusthoven
18 Cancer Vaccines ...................................................................................... 519Daniel Laheru
19 Optimising the Development of Antibodies as Treatment for Cancer ......................................................................... 535Craig P. Carden, Hendrik-Tobias Arkenau, and Johann S. de Bono
20 Oligonucleotide Therapeutics ................................................................ 569Cy A. Stein, Britta Hoehn, and John Rossi
21 Anticancer Drug Development in Pediatric Patients ........................... 589Lia Gore and Margaret Macy
22 Clinical Trials in Special Populations .................................................... 603S. Percy Ivy, Merrill J. Egorin, Chris H. Takimoto, and Jeannette Y. Wick
Part VI
23 NCI-Sponsored Clinical Trials ............................................................... 631Andriana Papaconstantinou and Janet E. Dancey
Index ................................................................................................................. 659
