Design and Analysis of Bridging Studies (Chapman & Hall/crc Biostatistics Series)

個数：

Design and Analysis of Bridging Studies (Chapman & Hall/crc Biostatistics Series)

Liu, Jen-pei (EDT)/ Chow, Shein-Chung (EDT)/ Hsiao, Chin-Fu (EDT)

ウェブストア価格 ¥12,771（本体¥11,610）
Chapman & Hall/CRC（2020/06発売）
外貨定価 US$ 62.99
ポイント 116pt

在庫がございません。海外の書籍取次会社を通じて出版社等からお取り寄せいたします。
通常6～9週間ほどで発送の見込みですが、商品によってはさらに時間がかかることもございます。
【重要ご説明事項】
1. 納期遅延や、ご入手不能となる場合がございます。
2. 複数冊ご注文の場合、分割発送となる場合がございます。
3. 美品のご指定は承りかねます。

●3Dセキュア導入とクレジットカードによるお支払いについて

【入荷遅延について】
世界情勢の影響により、海外からお取り寄せとなる洋書・洋古書の入荷が、表示している標準的な納期よりも遅延する場合がございます。
おそれいりますが、あらかじめご了承くださいますようお願い申し上げます。

◆画像の表紙や帯等は実物とは異なる場合があります。

◆ウェブストアでの洋書販売価格は、弊社店舗等での販売価格とは異なります。
また、洋書販売価格は、ご注文確定時点での日本円価格となります。
ご注文確定後に、同じ洋書の販売価格が変動しても、それは反映されません。

製本 Paperback:紙装版/ペーパーバック版／ページ数 287 p.
言語 ENG
商品コード 9780367576745
DDC分類 615.10727

Full Description

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 world under the same protocol.

Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores 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.

Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.

Bridging Diversity: Extrapolating Foreign Data to a New Region. Two-Stage Designs of Bridging Studies. Consistency of Treatment Effects in Bridging Studies and Global Multiregional Trials. Assessing Similarity Using the Reproducibility and Generalizability Probabilities and the Sensitivity Index. Combining Information in Clinical Drug Development: Bridging Studies and Beyond. A Bayesian Approach for Evaluation of Bridging Studies. Issues of Sample Size in Bridging Trials and Global Clinical Trials. Design and Sample Size Considerations for Global Trials. Application of Genomic Technologies for Bridging Strategy Involving Different Race and Ethnicity in Pharmacogenomics Clinical Trials. Interaction Effects in Bridging Studies. Multiregional Clinical Trials. Multiregional Clinical Trials for Global Simultaneous Drug Development in Japan. Feasibility and Implementation of Bridging Studies in Taiwan. Index.