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Pong, Annpey (Herausgeber); Chow, Shein-Chung (Herausgeber)

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development (Gebundene Ausgabe)

CRC PR INC, Oktober 2010


New. - 496 S. - Sprache: Englisch - 268x184x28 mm

ISBN: 1439810168 EAN: 9781439810163

Offers a unified presentation of the principles and methodologies in adaptive design and analysis. This title gives a summary of the regulatory perspectives and developed statistical methods in this area. It provides some insight regarding early phase and later phase adaptive designs.

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Inhaltsverzeichnis

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, Frank Bretz, Jose Pinheiro, and Bjorn Bornkamp 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, Arthur Berg, Kwangmi Ahn, Kiranmoy Das, Jiahan Li, Zhong Wang, Yao Li, and Rongling Wu Adaptive Trial Simulation, Mark Chang Efficiency of Adaptive Designs, Nigel Stallard and Tim Friede Cases Studies in Adaptive Design, Ning Li, Yonghong Gao, and Shiowjen Lee Good Practices for Adaptive Clinical Trials, Paul Gallo Index

Über den Autor

Annpey Pong is a manager in the Department of Biostatistics and Research Decision Sciences at Merck Research Laboratories. Dr. Pong is also the associate editor of the Journal of Biopharmaceutical Statistics. She earned her Ph.D. in statistics from Temple University. Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke-National University of Singapore Graduate Medical School and the editor of the Journal of Biopharmaceutical Statistics. He earned his Ph.D. in statistics from the University of Wisconsin-Madison.

ISBN 1-439810-16-8, ISBN 1-43-981016-8, ISBN 1-43981-016-8, ISBN 1-439-81016-8, ISBN 1-4398-1016-8

ISBN 978-1-439810-16-3, ISBN 978-1-43-981016-3, ISBN 978-1-43981-016-3, ISBN 978-1-439-81016-3, ISBN 978-1-4398-1016-3

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