This book offers professionals in clinical research essential insights into the complex issues surrounding the design, execution, and management of clinical trials. It effectively addresses these challenges and provides practical guidance on applying modern statistical techniques to safety evaluations during medical product development. Each chapter is rich with detailed information necessary for designing and analyzing experiments at different stages of product development, complemented by comprehensive references to relevant literature.

The guide covers a wide range of topics, assisting readers in undertaking the design and analysis of experiments at various stages of product development. It features numerous case studies throughout, along with SAS and R code examples, enhancing the reader’s understanding and application of statistical methods in this field.