ABSTRACT

As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. 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 w

chapter 1|16 pages

- Bridging Diversity: Extrapolating Foreign Data to a New Region

ByShein-Chung Chow, Chin-Fu Hsiao

chapter 2|16 pages

- Two-Stage Designs of Bridging Studies

ByChin-Fu Hsiao, Hsiao-Hui Tsou, Jen-pei Liu, and Yuh-Jenn Wu

chapter 3|16 pages

- Consistency of Treatment Effects in Bridging Studies and Global Multiregional Trials

ByWeichung J. Shih, Hui Quan

chapter 5|10 pages

- Combining Information in Clinical Drug Development: Bridging Studies and Beyond

ByKuang-Kuo Gordon Lan, José Pinheiro

chapter 6|16 pages

- A Bayesian Approach for Evaluation of Bridging Studies

ByChin-Fu Hsiao, Hsiao-Hui Tsou, Jen-pei Liu, and Yuh-Jenn Wu

chapter 7|16 pages

- Issues of Sample Size in Bridging Trials and Global Clinical Trials

ByHsien-Ming James Hung, Sue-Jane Wang, and Robert O’Neill

chapter 8|30 pages

- Design and Sample Size Considerations for Global Trials

ByChristy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama, Kazuhiko Kuribayashi

chapter 10|22 pages

- Interaction Effects in Bridging Studies

ByEric Tsung-Cheng Hsieh and Jen-pei Liu

chapter 11|16 pages

- Multiregional Clinical Trials

ByYi Tsong, Hsiao-Hui Tsou

chapter 12|16 pages

- Multiregional Clinical Trials for Global Simultaneous Drug Development in Japan

ByKihito Takahashi, Mari Ikuta, Hiromu Nakajima

chapter 13|14 pages

- Feasibility and Implementation of Bridging Studies in Taiwan

ByMey Wang, Yeong-Liang Lin, Herng-Der Chern