This book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality pharmaceutical products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes, and for providing the underpinnings for science-based regulation the pharmaceutical industry. Edited by three renowned researchers, the book is divided into three main sections.
The first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical modeling. The seven chapters in the second section present case studies. The last section discusses the needs for integrated tools and the status of the tools available for systematic data and knowledge management to support QbD.
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