With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

What was Muhammad Ali really like? Award winning photojournalist Michael Gaffney captures a rare insider's view of Ali's world as his personal photographer in 1977-1978. THE CHAMP is a journey with one of the most extraordinary treasures in our lifetime, Muhammad Ali, The Greatest. These stories - poignant, hilarious and authentic - reveal Ali's true courageous heart and go far beyond his glories in the ring. THE CHAMP is a perfect trilogy in the legendary fighter's career: a tough win against Earnie Shavers, a shocking loss of the World Heavyweight Championship to Leon Spinks, and a glorious redemptive comeback victory against Spinks to win the title for an unprecedented third time. THE CHAMP sustains the legacy of Muhammad Ali who continues to inspire millions and make the world a better place. "Congratulations to you, Michael Gaffney. THE CHAMP is one helluva achievement and one helluva book." BERT RANDOLPH SUGAR, Hall of Fame Boxing Historian

What does it take to achieve lasting improvement in student numeracy? According to the contributors in this volume, high quality teaching - combined with educational leadership at a school's and system's level - can attain just that. Founded upon evidence and research from the Leading Aligned Numeracy Development/LAND project (an Australian government initiative), this groundbreaking book provides a practical framework, as well as guidelines and tools, to develop teacher competence and to enhance leadership systems that support and consolidate student numeracy skills. Divided into sections that build on step-by-step principles and knowledge, the book is designed to address the 'numeracy challenge' from the perspectives of student achievement, teacher quality, school leadership, and system policy. Real-world insights, quotes, and examples are drawn from a range of schools and central offices in remote, rural, and metropolitan regions. A supporting website provides documentation that will assist school/departmental staff in implementing change and facilitating improvements in student numeracy that are measurable, achievable, and sustained. Packed with insights, actions, and expertise from educators who have participated in the project to achieve sustained school and system-wide numeracy improvement, the book provides a framework, the guidelines, and the tools for building alignment across school systems, taking a top-down, bottom-up approach.