Description: 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.
Price: 253 AUD
Location: Hillsdale, NSW
End Time: 2025-01-09T00:05:24.000Z
Shipping Cost: 31.22 AUD
Product Images
Item Specifics
Return shipping will be paid by: Buyer
Returns Accepted: Returns Accepted
Item must be returned within: 60 Days
Return policy details:
EAN: 9780367565602
UPC: 9780367565602
ISBN: 9780367565602
MPN: N/A
Item Length: 23.4 cm
Item Weight: 0.62 kg
Book Title: Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after Ich E17
Item Height: 234mm
Item Width: 156mm
Author: William Wang, Hui Quan, Bruce Binkowitz, Josh Chen, Gang Li
Format: Hardcover
Language: English
Publisher: Taylor & Francis Ltd
Publication Year: 2021
Number of Pages: 304 Pages