Books by Shein-Chung (Duke Univ Chow

Written by one of the preeminent experts in the field, this book covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. It focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development

"Focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It will cover current issues, and recent development in analytical similarity assessment"--

-A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc.-

This acclaimed book covers the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures based on accrued data of ongoing clinical trials. It presents a well-balanced summary of current regulatory perspectives, recently developed statistical methods, and statistical tests for seamless phase II/III adaptive designs. This edition features two new chapters as well as a complete rewrite of the chapter on computer simulation. It also includes computer simulations and various case studies to ensure a practical understanding of the methodologies.