Bøker av Shein-Chung (Duke Univ Chow

This second edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. This edition significantly updates the chapters on p

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

-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.

Presents statistical designs and methods of analysis for various stages of pharmaceutical development. This book emphasizes biopharmaceutical applications and demonstrates statistical techniques with real-world examples.