A TWO-STAGE DESIGN FOR BRIDGING STUDIES

Author:

Hsiao Chin-Fu1,Xu Jia-Zhen1,Liu Jen-pei23

Affiliation:

1. a Division of Biostatistics and Bioinformatics , National Health Research Institutes , Taipei, Taiwan

2. b Division of Biostatistics and Bioinformatics , National Health Research Institutes , Taipei, Taiwan

3. c Division of Biometry, Department of Agronomy , National Taiwan University , Taipei, Taiwan

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference8 articles.

1. ASSESSING SENSITIVITY AND SIMILARITY IN BRIDGING STUDIES

2. A Group Sequential Approach to Evaluation of Bridging Studies

3. ICH, International Conference on Harmonisation . ( 1998 ). Tripartite Guidance E5, Ethnic Factors in the Acceptability of Foreign Data . Washington , DC : The U.S. Federal Register , 83 , pp. 31,790 – 31,796 .

4. Sample Size Requirements for Evaluation of Bridging Evidence

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