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Phase I cancer clinical trials : a practical guide /

Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeu...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Eisenhauer, Elizabeth A. (Editor ), Twelves, Chris (Editor ), Buyse, Marc E. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Oxford ; New York : Oxford University Press, [2015]
Edición:Second edition.
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 1. Introduction / Elizabeth A. Eisenhauer
  • 2. Preclinical data and requirements / Sophie Postel-Vinay, Jean-Charles Soria, Elizabeth A. Eisenhauer
  • 3. Phase 0 clinical trials / Shivaani Kummar and James H. Doroshow
  • 4. Basics of phase I design : first-in-human studies / Donna M. Graham, Aaron R. Hansen, Elizabeth A. Eisenhauer, and Lillian L. Siu
  • 5. Ethical issues in first-in-human phase I cancer trials / Elizabeth A. Eisenhauer
  • 6. Phase I trials in special populations and circumstances / Rajiv Kumar, Chris Twelves, and Udai Banerji
  • 7. Phase I trials of immunotherapeutics / Christy Ralph, Emma King, Chris Twelves, and Christian Ottensmeier
  • 8. Statistical designs for first-in-man phase I cancer trials / Xavier Paoletti and Marc Buyse
  • 9. Writing the protocol / Penelope A. Bradbury and Elizabeth A. Eisenhauer
  • 10. Practical aspects of pharmacokinetics and pharmacodynamics / Chris Twelves, Maria Jove, and Paul Loadman
  • 11. Process, pitfalls, and logistics of phase I trials / Elizabeth A. Eisenhauer, Chris Twelves, Hayley Farmer, Philip Ross
  • 12. Reporting and interpreting results / Lesleigh S. Abbott, Elizabeth A. Eisenhauer and Lesley K. Seymour.