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Design and analysis of cross-over trials / Byron Jones and Michael G. Kenward.

By: Contributor(s): Material type: TextTextSeries: Monographs on statistics and applied probability ; 138.Publication details: Boca Raton : CRC Press, c2015.Edition: 3rd edDescription: xxvi, 412 p. : illustrations ; 25 cmISBN:
  • 9781439861424 (hardback)
Subject(s): DDC classification:
  • 000SA.2 23 J76
Contents:
1. Introduction -- 2. The 2x2 cross-over trial -- 3. Higher-order for two treatments -- 4. Designing cross-over trials -- 5. Analysis of continuous data -- 6. Analysis of discrete data -- 7. Bioequivalence trials -- 8. Case study : phase I dose-response noninferiority trial -- 9. Case study : choosing a dose-response model -- 10. Case study : conditional power -- 11. Case study : proof of concept trial with sample size re-estimation -- 12. Case study : blinded sample size re-estimation in a bioequivalence study -- 13. Case study : unblinded sample size re-estimation in a bioequivalence study that has a group sequential design -- 14. Case study : various methods for an unblinded sample size re-estimation in a bioequivalence study-- Appendix-- Bibliography-- Index.
Summary: This edition has been updated with recent references and new material on analysis of small trials, analysis of baseline measurements, bioequivalence, cross-over trials in early phase drug development, and adaptive cross-over trials. The book includes numerous real examples, including some new data sets to illustrate the methods described, with SAS code available for their implementation.
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Includes bibliographical references and index.

1. Introduction --
2. The 2x2 cross-over trial --
3. Higher-order for two treatments --
4. Designing cross-over trials --
5. Analysis of continuous data --
6. Analysis of discrete data --
7. Bioequivalence trials --
8. Case study : phase I dose-response noninferiority trial --
9. Case study : choosing a dose-response model --
10. Case study : conditional power --
11. Case study : proof of concept trial with sample size re-estimation --
12. Case study : blinded sample size re-estimation in a bioequivalence study --
13. Case study : unblinded sample size re-estimation in a bioequivalence study that has a group sequential design --
14. Case study : various methods for an unblinded sample size re-estimation in a bioequivalence study--
Appendix--
Bibliography--
Index.

This edition has been updated with recent references and new material on analysis of small trials, analysis of baseline measurements, bioequivalence, cross-over trials in early phase drug development, and adaptive cross-over trials. The book includes numerous real examples, including some new data sets to illustrate the methods described, with SAS code available for their implementation.

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