Başlık:
Design and analysis of cross-over trials
Yazar:
Jones, Byron, author.
ISBN:
9781439861431
Basım Bilgisi:
Third edition.
Fiziksel Tanımlama:
1 online resource
Seri:
Chapman & Hall / CRC monographs on statistics & applied probability ; 138
İçerik:
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.
Özet:
Since the publication of the second edition, there has been significant research and development in cross-over trials, which continue to be an important design technique in the pharmaceutical industry. This new 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-- Provided by publisher.
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