The application of Quality by Design (QbD) has been increasingly receiving worldwide attention at all levels of the chemical engineering industry. The book covers a widespread view of Quality by Design (QbD) encompassing the multiple steps involved in the development of a new drug. These steps are traditionally studied by separate and statistical means. This book focuses on practical aspects of QbD for establishing links between these steps. Establishing the necessary theory to identify these relationships enhances the level of process understanding and provides the means for a science-based regulation of the pharmaceutical industry. The book guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, how to utilize QbD practices and applications effectively while complying with government regulations. This methodology has been applied in several industry sectors, but has only recently attracted the attention of the pharmaceutical industry. The material is divided into six main sections, each of which will include between 3 and 12 chapters/contributions: Overview of QbD in the pharmaceutical sector; Regulatory aspects of QbD; QbD applications across different product categories; Use of modeling and process control in QbD; Lessons from QbD practice in other industry sectors; Emerging QbD developments
