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Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 (Chapman & Hall/CRC Biostatistics Series) - Softcover
- PublisherChapman and Hall/CRC
- Publication date2024
- ISBN 10 0367625792
- ISBN 13 9780367625795
- BindingPaperback
- Edition number1
- Number of pages302
- EditorLi Gang, Binkowitz Bruce, Wang William, Quan Hui, Chen Josh
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Simultaneous Global New Drug Development : Multi-regional Clinical Trials After Ich E17
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Simultaneous Global New Drug Development (Paperback)
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Paperback. Condition: NEW. Paperback. Global simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from many geographical regions around the world, MRCTs can speed up the patient enrolment, thus resulting in quicker drug development and obtaining faster approval of the drug globally.After the publication of the editors first volume on this topic, there have been new developments on MRCTs. The International Council for Harmonisation (ICH) issued ICH E17, a guideline document on MRCTs, in November 2017, laying out principles on MRCTs. Beyond E17, new methodologies have been developed as well. Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 collects chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. In addition, in contrast to the first book, new perspectives are brought to MRCT from regulatory agencies. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products. It will also be especially helpful for statisticians in regulatory agencies, and medical research institutes.This book is comprehensive across the MRCT topic spectrum, including Issues regarding ICH E17 Implementation MRCT Design and Analysis Methodologies Perspectives from authorities in regulatory agencies, as well as statisticians practicing in the medical product industry Many examples of real-life applications based on actual MRCTs. This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. Seller Inventory # 9780367625795
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Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17
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Taylor & Francis Ltd, 2024
ISBN 10: 0367625792
ISBN 13: 9780367625795
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Paperback. Condition: Brand New. 316 pages. 9.19x6.13x0.67 inches. In Stock. This item is printed on demand. Seller Inventory # __0367625792
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Condition: NEW. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Dr. Gang Li is Senior Director, Real World Evidence (RWE) and Medical Value, the Neurology Business Group of Eisai Inc. He received his PhD in Mathematical Statistics from the State University of New York at Binghamton. He co-authored ov. Seller Inventory # 1241774621
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