Introduction

The introductory chapter explains the book's context, describing the scope and impact of pharmaceutical process research and development. Each chapter is a story describing activities that are interdependent, but occur over several years from discovery of an active pharmaceutical to its commercial production. The book aims to provide an overview of how safe and scalable synthetic routes are designed, selected and developed, the importance of chemical engineering, analytical and manufacturing interfaces, as well as green chemistry and solid form issues. Several examples illustrate the increasingly difficult type of process issues being faced, and the innovative solutions being implemented, as the drug candidates being discovered and developed are becoming more active, selective and, in many cases, more complex.