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Multiregional Clinical Trials for Simultaneous Global New Drug Development
Engelsk Hardback
SPAR
kr 186
Multiregional Clinical Trials for Simultaneous Global New Drug Development
Engelsk Hardback

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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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.

Produktdetaljer
Sprog: Engelsk
Sider: 353
ISBN-13: 9781498701464
Indbinding: Hardback
Udgave:
ISBN-10: 1498701469
Kategori: Kliniske forsøg
Udg. Dato: 1 apr 2016
Længde: 27mm
Bredde: 243mm
Højde: 284mm
Oplagsdato: 1 apr 2016
Forfatter(e):
Forfatter(e)


Kategori Kliniske forsøg


Sprog Engelsk


Indbinding Hardback


Sider 353


Udgave


Længde 27mm


Bredde 243mm


Højde 284mm

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