By Jen-pei Liu, Shein-Chung Chow, Chin-Fu Hsiao
This e-book offers a finished and unified precis of the growing to be literature and study actions on regulatory standards, medical and useful matters, and statistical technique bearing on the layout and review of bridging experiences, which supply pharmacodynamic or medical facts that permit extrapolation of the overseas medical facts to a brand new quarter. in addition to a radical assessment of bridging experiences, the textual content addresses matters coming up from bridging stories, together with ethnic sensitivity, necessity of bridging reviews, forms of bridging reviews, and overview of similarity b. Read more...
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Additional resources for Design and analysis of bridging studies
Chapter 4 discusses the possibility for assessing similarity based on the reproducibility and generalizability and sensitivity index proposed by Shao and Chow (2002) and Chow et al. (2002), respectively. , number of patients) for domestic registration of a new compound. A Bayesian approach for assessment of bridging studies is discussed in Chapter 6. Chapters 7 and 8 give a comprehensive overview of statistical methods for bridging studies and multiregional clinical trials conducted in global development.
This makes sense, since the original region will spend more power than the new region as γ2 decreases. In addition, the critical value at the final analysis also increases as γ2 decreases. 7. On the other hand, it is notable that the sample size in the original region increases as γ1 increases. This fact is because that the larger the γ1, the more power under HO will be spent by the original region. In other words, the regulatory agencies in both original and new regions and the sponsor should make considerable decision on how they want to spend the type I and type II error probabilities at each stage.
Sample size considerations for Japanese patients based on MHLW guidance. Pharmaceutical Statistics, 9: 100–112. , and Chow, S. C. (2002). Reproducibility probability in clinical trials. Statistics in Medicine, 21: 1727–1742. Shih, W. J. (2001). Clinical trials for drug registration in Asian-Pacific countries: Proposal for a new paradigm from a statistical perspective. Controlled Clinical Trials, 22: 357–366. Uesaka, H. (2009). Sample size allocation to regions in multiregional trial. Journal of Biopharmaceutical Statistics, 19: 580–595.