This will be the third edition of Statistical Issues in Drug Development, and will be fully revised and updated to include information on the latest industry standards and guidelines. Both the first (1997) and second (2007) editions were very well received and the book has become a standard.
This book is unique in providing a thorough and critical discussion of the most important and controversial issues encountered by statisticians and their life scientist colleagues on both sides of the regulatory divide in drug development. The primary purpose of the book is to encourage and facilitate discussion between statisticians and their colleagues of the many complex statistical issues that arise in drug development. The book will be suitable as a course of self-instruction for statisticians who are new to the pharmaceutical industry, either because of recent graduation or change of career. It will also act as an authoritative reference for those working in drug development, and provide possible topics for discussion in journal forums.