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Multiregional Clinical Trials for Simultaneous Global New Drug Development (Paperback)
Loot Price: R1,467
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Multiregional Clinical Trials for Simultaneous Global New Drug Development (Paperback)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 working days
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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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