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Published by Chapman and Hall/CRC 2012-08-31, 2012
ISBN 10: 1439846340 ISBN 13: 9781439846346
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Add to basketGebunden. Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Jen-pei Liu is a professor in the Division of Biometry, Department of Agronomy, and Institute of Epidemiology and Preventative Medicine at National Taiwan University. He is also an adjunct investigator in the Institute of Population Heal.
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ISBN 10: 1439846340 ISBN 13: 9781439846346
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Add to basketBuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Taking into account the International Conference Harmonisation E5 framework for bridging studies, this book covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials. For bridging studies, the authors explore ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region.