Phase I Cancer Clinical Trials: A Practical Guide
作者： Marc E. Buyse , Elizabeth A Eisenhauer , Christopher Twelves
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摘要: 1. Introduction 2. Preclinical data and requirements 3. Basics of Phase I Design: first-in-man studies 4. Ethical issues in Cancer Trials 5. special populations 6. Statistical designs for 7. Writing the protocol 8. Before you begin 9. Practical aspects pharmacokinetics pharmacodynamics 10. Running study 11. Reporting interpreting results Appendices
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