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Pharmaceutical Book from C.H.I.P.S.

Statisical Methods for Dose-Finding Experiments
edited by Sylvie Chevret

Statisical Methods for Dose-Finding Experiments reviews the main statistical approaches for dose-finding in phase I/II clinical trials and presents practical guidance on their correct use.

Features:

  • Includes an introductory section, summarizing the essential concepts in dose-finding
  • Contains a section on algorithm-based approaches, such as the traditional 3+3 design, and a section on model-based approaches, such as the continual reassessment method
  • Explains fundamental issues, such as how to stop trials early and how to cope with delayed or ordinal outcomes
  • Discusses in detail the main websites and software used to implement the methods
  • Features numerous worked examples making use of real data

Contents

  1. Basic concepts in dose-finding
  2. Philosophy and methodology of dose-finding – a regulatory perspective (Robert Hemmings).
  3. Traditional and modified algorithm-based designs for phase I cancer clinical trials (Weichung Joe Shih and Yong Lin).
  4. Accelerated titration designs (Janet Dancey, Boris Freidlin and Larry Rubinstein)
  5. Group up-and-down designs in toxicity studies (Anna Ivanova and Nancy Flournoy).
  6. The continual reassessment method (Sylvie Chevret and Sarah Zohar).
  7. Using Bayesian decision theory in dose-escalation studies (John Whitehead).
  8. Dose-escalation with overdose control (Mourad Tighiouart and Andr´e Rogatko).
  9. Dose-escalation methods for phase I healthy volunteer studies (Y. Zhou).
  10. Defining stopping rules (Sarah Zohar).
  11. Dose-finding with delayed binary outcomes in cancer trials (Ying Kuen Cheung).
  12. Dose-finding based on multiple ordinal toxicities in phase I oncology trials (B. Nebiyou Bekele and Peter F. Thall).
  13. A two-stage design for dose-finding with two agents (Peter F. Thall)
  14. Using both efficacy and toxicity for dose-finding (Peter F. Thall and John D. Cook).
  15. Websites and software

Index

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Statisical Methods for Dose-Finding Experiments
edited by Sylvie Chevret
2006 • 334 pages • $109.00 + shipping
Texas residents please add 6.75 % sales tax

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