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Design and Analysis of Bridging Studies

By Jen-Pei Liu

Design and Analysis of Bridging Studies Medicine

Design and Analysis of Bridging Studies

By Jen-Pei Liu

- Default Title
Description
Taking into account the International Conference Harmonisation E5 framework for bridging studies, this book covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials. For bridging studies, the authors explore ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region.
Product details
Edition:
1
Number of Pages:
288
Release Date:
2012-07-26
Publication Date:
2012-07-26
Publisher:
Chapman and Hall/CRC
Languages:
Original: English
ISBN10:
1439846340
ISBN13:
9781439846346
GPSR Manufacturer Reference:
[email protected]
Weight:
599 g
Height:
161 cm
Width:
240 cm
Thickness:
20 cm
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