Description: Multiregional Clinical Trials for Simultaneous Global New Drug Development, Hardcover by Chen, Joshua (EDT); Quan, Hui (EDT), ISBN 1498701469, ISBN-13 9781498701464, Brand New, Free shipping in the US 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. Th 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. Th 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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Book Title: Multiregional Clinical Trials for Simultaneous Global New Drug De
Number of Pages: 353 Pages
Publication Name: Multiregional Clinical Trials for Simultaneous Global New Drug Development
Language: English
Publisher: CRC Press LLC
Item Height: 1 in
Subject: Biostatistics, Clinical Medicine, Probability & Statistics / General, Pharmacology
Publication Year: 2016
Type: Textbook
Item Weight: 24.1 Oz
Author: Hui Quan
Subject Area: Mathematics, Medical
Item Length: 9.5 in
Series: Chapman and Hall/Crc Biostatistics Ser.
Item Width: 6.4 in
Format: Hardcover
