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Handbook of adaptive designs in pharmaceutical and clinical development /
This comprehensive guide offers a unified presentation of the principles and methodologies in adaptive design and analysis. It gives a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. The handbook provides some insight regarding early...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Boca Raton, FL :
CRC Press,
2010.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 245 | 0 | 0 | |a Handbook of adaptive designs in pharmaceutical and clinical development / |c edited by Annpey Pong, Shein-Chung Chow. |
| 264 | 1 | |a Boca Raton, FL : |b CRC Press, |c 2010. | |
| 300 | |a 1 online resource (475 pages) | ||
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| 520 | |a This comprehensive guide offers a unified presentation of the principles and methodologies in adaptive design and analysis. It gives a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. The handbook provides some insight regarding early phase and later phase adaptive designs. With a focus on the implementation of adaptive methods in clinical trials, it introduces the concepts of role, responsibility, function, and activity of a data safety monitoring board (DSMB) when applying these methods. Other important topics covered in detail. | ||
| 505 | 0 | |a Overview of adaptive design methods in clinical trials / Annpey Pong and Shein-Chung Chow -- Fundamental theory of adaptive designs with unplanned design change in clinical trials with blinded data / Qing Liu and George Y.H. Chi -- Bayesian approach for adaptive design / Guosheng Yin and Ying Yuan -- The impact of protocol amendments in adaptive trial designs / Shein-Chung Chow and Annpey Pong -- From group sequential to adaptive designs / Christopher Jennison and Bruce W. Turnbull -- Determining sample size for classical designs / Simon Kirby and Christy Chuang-Stein -- Sample size reestimation design with applications in clinical trials / Lu Cui and Xiaoru Wu -- Adaptive interim analyses in clinical trials / Gernot Wassmer -- Classical dose-finding trial / Naitee Ting -- Improving dose-finding: a philosophic view / Carl-Fredrik Burman, Frank Miller, and Kiat Wee Wong -- Adaptive dose-ranging studies / Marc Vandemeulebroecke [and others] -- Seamless phase I/II designs / Vladimir Dragalin -- Phase II/III seamless designs / Jeff Maca -- Sample size estimation/allocation for two-stage seamless adaptive trial designs / Shein-Chung Chow and Annpey Pong -- Optimal response-adaptive randomization for clinical trials / Lanju Zhang and William Rosenberger -- Hypothesis-adaptive design / Gerhard Hommel -- Treatment adaptive allocations in randomized clinical trials: an overview / Atanu Biswas and Rahul Bhattacharya -- Integration of predictive biomarker diagnostics into clinical trials for new drug development / Richard Simon -- Clinical strategy for study endpoint selection / Siu Keung Tse, Shein-Chung Chow, and Qingshu Lu -- Adaptive infrastructure / Bill Byrom, Damian McEntegart, and Graham Nicholls / Independent data monitoring committees / Steven Snapinn and Qi Jiang -- Targeted clinical trials / Jen-Pei Liu -- Functional genome-wide association studies of longitudinal traits / Jiangtao Luo [and others] -- Adaptive trial simulation / Mark Chang -- Efficiency of adaptive designs / Nigel Stallard and Tim Friede -- Case studies in adaptive design / Ning Li, Yonghong Gao, and Shiowjen Lee -- Good practices for adaptive clinical trials / Paul Gallo. | |
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| 700 | 1 | |a Pong, Annpey. | |
| 700 | 1 | |a Chow, Shein-Chung, |d 1955- | |
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| 776 | 0 | 8 | |i Print version: |a Pong, Annpey. |t Handbook of Adaptive Designs in Pharmaceutical and Clinical Development. |d Hoboken : CRC Press, ©2010 |z 9781439810163 |
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