Multiregional Clinical Trials for Simultaneous Global New Drug Development

全球同步新药开发的多区域临床试验

药物化学

原   价:
616.00
售   价:
493.00
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平台大促 低至8折优惠
发货周期:预计5-7周发货
出  版 社
出版时间
2020年12月18日
装      帧
平装
ISBN
9780367737221
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页      码
376
开      本
234 x 156 mm (6.14 x 9.21
语      种
英文
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图书简介
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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