This book provides a comprehensive and unified summary of the growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology pertaining to the design and evaluation of bridging studies, which provide pharmacodynamic or clinical data that allow extrapolation of the foreign clinical data to a new region. Along with a thorough overview of bridging studies, the text addresses issues arising from bridging studies, including ethnic sensitivity, necessity of bridging studies, types of bridging studies, and assessment of similarity between regions based on bridging evidence

Introduction—Examples and Regulatory Requirements. Designs for Bridging Studies. Criteria for Assessment of Bridging Studies. Predictive Power Approach. Weighted Approach. Bayesian Approach. Issue of Sample Size in Bridging Studies. Statistical Inference of Bridging Studies in Global Drug Development. The Application of Genomic Technologies in Bridging Studies. Interaction/Confounding Effects in Bridging Studies. Special Population in Bridging Studies. Feasibility and Implementation of Bridging Studies—Experience from Asian Pacific Regions.