Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 (Chapman & Hall/CRC Biostatistics Series)

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Synopsis
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. 　
Copyright:
2022

Book Details

Book Quality:
Publisher Quality
Book Size:
302 Pages
ISBN-13:
9781000485066
Related ISBNs:
9781003109785, 9780367625795, 9780367565602
Publisher:
CRC Press
Date of Addition:
Copyrighted By:
selection and editorial matter, Gang Li, Bruce Binkowitz, William Wang, Hui Quan, and Josh Chen
Adult content:
No
Language:
English
Has Image Descriptions:
No
Categories:
Nonfiction, Mathematics and Statistics, Medicine
Submitted By:
Bookshare Staff
Usage Restrictions:
This is a copyrighted book.
Edited by:
Gang Li
Edited by:
Bruce Binkowitz
Edited by:
William Wang
Edited by:
Hui Quan
Edited by:
Josh Chen

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