{"product_id":"design-and-analysis-of-bridging-jen-pei-liu-9781439846346","title":"Design and Analysis of Bridging Studies","description":"\u003cp\u003eAs 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.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eDesign and Analysis of Bridging Studies\u003c\/strong\u003e 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.\u003c\/p\u003e\u003cp\u003eTaking 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.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Jen-Pei Liu\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1439846340\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781439846346\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 07\/26\/2012\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 287\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.28lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.21h x 6.14w x 0.69d","brand":"Jen-Pei Liu","offers":[{"title":"Hardcover","offer_id":43980368150783,"sku":"9781439846346","price":140.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_6bb8575c-a560-45c3-bb83-8644b3d3691f.jpg?v=1683249530","url":"https:\/\/www.whiterainbookhouse.com\/products\/design-and-analysis-of-bridging-jen-pei-liu-9781439846346","provider":"WR Book House","version":"1.0","type":"link"}