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- 1 IntroductionElizabeth A. Eisenhauer
- 2 Preclinical Data and RequirementsSophie Postel-Vinay, Jean-Charles Soria, and Elizabeth A. Eisenhauer
- 3 Phase 0 Clinical TrialsShivaani Kummar and James H. Doroshow
- 4 Basics of Phase I Design: First-in-Human StudiesDonna M. Graham, Aaron R. Hansen, Elizabeth A. Eisenhauer, and Lillian L. Siu
- 5 Ethical Issues in First-in-Human Phase I Cancer TrialsElizabeth A. Eisenhauer
- 6 Phase I Trials in Special Populations and CircumstancesRajiv Kumar, Chris Twelves, and Udai Banerji
- 7 Phase I Trials of ImmunotherapeuticsChristy Ralph, Emma King, Chris Twelves, and Christian Ottensmeier
- 8 Statistical Designs for First-in-Man Phase I Cancer TrialsXavier Paoletti and Marc Buyse
- 9 Writing the ProtocolPenelope A. Bradbury and Elizabeth A. Eisenhauer
- 10 Practical Aspects of Pharmacokinetics and PharmacodynamicsChris Twelves, Maria Jove, and Paul Loadman
- 11 Process, Pitfalls, and Logistics of Phase I TrialsElizabeth A. Eisenhauer, Chris Twelves, Hayley Farmer, and Philip Ross
- 12 Reporting and Interpreting Results Lesleigh S. Abbott, Elizabeth A. Eisenhauer, and Lesley K. Seymour