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Design and Analysis of Bridging Studies
About this book
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
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Yes, you can access Design and Analysis of Bridging Studies by Jen-pei Liu,Shein-Chung Chow,Chin-Fu Hsiao in PDF and/or ePUB format, as well as other popular books in Mathematics & Biostatistics. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Cover Page
- Halftitle Page
- Series Page
- Chapman & Hall/CRC Biostatistics Series
- Title Page
- Copyright Page
- Contents
- Preface
- Contributors
- 1 : Bridging Diversity: Extrapolating Foreign Data to a New Region
- 2: Two-Stage Designs of Bridging Studies
- 3: Consistency of Treatment Effects in Bridging Studies and Global Multiregional Trials
- 4 : Assessing Similarity Using the Reproducibility and Generalizability Probabilities and the Sensitivity Index
- 5: Combining Information in Clinical Drug Development: Bridging Studies and Beyond
- 6: A Bayesian Approach for Evaluation of Bridging Studies
- 7: Issues of Sample Size in Bridging Trials and Global Clinical Trials*
- 8: Design and Sample Size Considerations for Global Trials*
- 9: Application of Genomic Technologies for Bridging Strategy Involving Different Race and Ethnicity in Pharmacogenomics Clinical Trials*
- 10: Interaction Effects in Bridging Studies*
- 11: Multiregional Clinical Trials*
- 12 : Multiregional Clinical Trials for Global Simultaneous Drug Development in Japan
- 13 : Feasibility and Implementation of Bridging Studies in Taiwan*