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Simultaneous Global New Drug Development

Simultaneous Global New Drug Development

Pages: 316

Publisher: Chapman & Hall

Year of Publication: 2024

Author(s) : Gang Li, Bruce Binkowitz, William Wang, Hui Quan, Josh Chen

Book Description:

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.

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