Multiregional_Clinical_Trials_for_Simultaneous_Global_New_Drug_Development_Chapman_Hall_CRC_Biostat

Multiregional Clinical Trials for Simultaneous Global New
Drug Development (Chapman & Hall/CRC Biostatistics
Series)
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Multiregional Clinical Trials for Simultaneous Global New
Drug Development (Chapman & Hall/CRC Biostatistics
Series)
BOOK DETAIL
Series: Chapman & Hall/CRC Biostatistics Series Hardcover: 375 pages Publisher: Chapman and Hall/CRC;
1 edition (April 1, 2016) Language: English ISBN-10: 1498701469 ISBN-13: 978-1498701464 Product
Dimensions: 6.1 x 9.2 inches Shipping Weight: 1.7 pounds (View shipping rates and policies)
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Book Description
In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the
development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New
Drug Development presents a comprehensive overview on the current status of conducting
MRCTs in clinical development. International experts from academia, industry, and health
organizations address various aspects of the important problems in global clinical development
and MRCTs. The book first provides a high-level introduction to the context, motivation,
opportunities, and challenges in simultaneous global clinical development using MRCTs. It then
focuses on the design, monitoring, and analysis/interpretation of MRCTs. The book concludes
with an examination of the latest research topics from MRCT perspectives, such as special
considerations by local health authorities, health economic evaluations, benefit-risk assessment,
and medical devices. Explaining how to design, conduct, and interpret MRCTs, this book will
help biostatisticians working in the late-stage clinical development of medical products. It will
also be useful for statisticians and clinicians in the biopharmaceutical industry, regulatory
agencies, and medical research institutes.

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