Design and Analysis of Bridging Studies
Liu, Jen-pei / Chow, Shein-Chung / Hsiao, Chin-Fu
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 betw...