Michael Gaffney

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.

The roads to school system improvement can be rocky. The nature of schools and school systems makes them very difficult to change. These are complex organisations, subject to a range of demands and opportunities from multiple stakeholders – from parents and governments, from local communities and business, from other educational authorities and institutions, and, of course, from their staff and students. Effective educational leaders appreciate this complexity and work with colleagues and others across and beyond their education system to make a positive and meaningful difference. Pathways to School System Improvement is designed for educators with an interest and responsibility for school system improvement. Drawing on data from two national pilot programs – Principals as Literacy Leaders (PALL) and Leading Aligned Numeracy Development (LAND) – it looks at effective strategies for implementing system improvement and presents approaches for capitalising on the successes and overcoming the shortcomings of initiative-based reforms. Key features:Uses two major pilot programs as case studies. Provides framework and principles for system development. Strong theoretical/research basis.

In the current economy, prospective brides, party givers, and commercial businesspeople are looking for ways to create their own sophisticated floral arrangements rather than hire expensive third parties. Featuring a well-known designer's foolproof methods, this lush guidebook brings readers into the world of the professional with secrets, tips, and formulas for great design, including step-by-step instructions on everything from Classic English design to Exotic Tropical design. With more than 400 color photos detailing dozens of start-to-finish arrangements, the book provides a beautiful display of finished projects for readers to replicate. It also guides them through the basics of opening a flower shop or becoming a professional flower designer.