Böcker 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

Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability testing, focuses on short-term stability studies, and reviews several methods for estimating drug expiration dating periods. The author compares some commonly employed study designs and discusses both

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

-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.

Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability testing. It focuses on short-term stability studies, and reviews several methods for estimating drug expiration dating periods.