Author:
Edition: 1
Publisher: Chapman and Hall/CRC
Binding: Hardcover
ISBN: 1439846340
Design and Analysis of Bridging Studies (Chapman & Hall/CRC Biostatistics Series)
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. Medical books Design and Analysis of Bridging Studies . To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol.
Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores 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 Medical books Design And Analysis Of Bridging Studies Liu, Jen-pei (edited By)/ Chow, Shein-ch. format hardback language english publication year 08 08 2012 series chapman hall crc biostatistics series subject medicine subject 2 clinical medicine professional title design and analysis of bridging studies author liu jen pei edited by chow shein chung edited by hsiao chin fu edited by publisher chapman hall publication date may 26 2012 pages 350 binding hardcover edition 1 st dimensions 6 40 wx 9 30 hx 0 70 d isbn 1439846340 subject mathematics probability statistics general description in
Download link for Design And Analysis Of Bridging Studies By Chin-fu Hsiao Hardcover Book (eng
Medical Book Design and Analysis of Bridging Studies
To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol.
Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores 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.
Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.
